CRITERIA FOR
ACCEPTABILITY OF
RADIOLOGICAL,
NUCLEAR MEDICINE
AND RADIOTHERAPY
EQUIPMENT
FINAL DRAFT AMENDED-V1.4-091001
E U R O P E A N C O M M I S S I O N
C O N T R A C T N O . T R E N / 0 7 / N U C L / S 0 7 . 7 0 4 6 4
Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment
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FOREWORD (TO BE WRITTEN BY THE CEC)
Notes that may be useful aide memoir for Foreword:
Background to directives
Key points to be mentioned by the Commission
Key changes
More detailed report, extended in length from about 20 to over 100 pages.
Much more explicit attention to Radiotherapy and Nuclear Medicine.
Definition creep. Use of Suspension Levels (redefined) as key component of definition. Evidence base for criteria, and their classification according to evidence base. Some areas not as developed as we would have liked and evidence base for criteria in short supply.
Inclusion of process for dealing with exceptions including rapidly changing technology.
Harmonisation with requirements of MDD.
New: More explicit statements of process to be used for application of Criteria in practice.
The Commission is grateful to Dr Keith Faulkner who coordinated the overall project and to Professor Jim Malone (Introduction and Diagnostic Radiology Lead), Dr Stelios Christofides (Nuclear Medicine Lead) and Professor Stephen Lillicrap (Radiotherapy Lead), who coordinated the work in the specialist areas indicated.
FOREWORD TO ORIGINAL DOCUMENT
The work of the European Commission in the field of radiation protection is governed by the
Euratom Treaty and the Council Directives made under it.
The most prominent is the Basic Safety Standards Directive (BSS) on the protection of
exposed workers and the public (80/836/Euratom) revised in 1996 (96/29/Euratom).
In 1984 Council issued a complementary Directive to the BSS on the protection of persons
undergoing medical exposures (84/466/Euratom) revised in 1997 (97/43/Euratom).
Both Directives require the establishment by the Member States of criteria of acceptability of
radiological (including radiotherapy) installations and nuclear medicine installations.
Experience showed that drawing up such criteria, especially as regards the technical
parameters of the equipment, sometimes created difficulties.
Therefore in 1990, the Commission took the initiative to develop examples of criteria of
acceptability (Bland, N.R.P.B.).
Following two constructive meetings with competent authorities of the Member States
(18/9/1992 and 30/3/1994) a need for extension to specific radiological and nuclear medicine
installations was forwarded. In 1995 an inquiry among competent authorities was made (Kal
& Zoetelief) to make an evaluation of the existing situation resulting in a new report
suggesting additional criteria for these installations.
This report, amended with data from other sources, was discussed with competent
authorities in Luxembourg on 4 and 5 September 1996.
The result is a flavour of criteria of acceptability applicable to facilities in use for radiology,
radiotherapy and nuclear medicine. These criteria are not binding to the Member States but
were prepared to assist competent authorities in their task to establish or to review criteria of
acceptability, also called minimum criteria. They should not be confused with the
requirements for design and construction of radiological and nuclear medicine equipment as
mentioned in annex I, part 2, § 11,5 of the Council Directive on medical devices (93/42/EEC).
This report will be reviewed on a regular basis in order to take into account new scientific and
technical data as appropriate.
It forms part of a series of technical guides on different subjects developed to facilitate the
implementation of the Directive on medical exposures. It is my hope that the document will
help to ensure continuing improvement in radiation protection in the medical field.
Suzanne FRIGREN
Director Nuclear Safety and Civil Protection
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CONTENTS
FOREWORD (To be written by the CEC) ______________________________________________ 2
FOREWORD TO ORIGINAL DOCUMENT ______________________________________________ 3
CONTENTS ______________________________________________________________________ 4
1. INTRODUCTION ______________________________________________________________ 6
1.1. Purpose and Background __________________________________________________ 6
1.2. Basis for Criteria of Acceptability in European Directives _______________________ 8 1.2.1. Requirements of the Medical Exposure Directive _____________________________ 8 1.2.2. Wider context, the MDD Directive and Equipment Standards __________________ 10
1.3. To whom this document is addressed ______________________________________ 12
1.4. Criteria of Acceptability __________________________________________________ 13 1.4.1. Approaches to Criteria _________________________________________________ 13 1.4.2. Suspension Levels ___________________________________________________ 14 1.4.3. Identifying and Selecting Criteria _________________________________________ 16
1.5. Special Considerations, Exceptions and Exclusions __________________________ 18 1.5.1. Special Considerations ________________________________________________ 18 1.5.2. Exceptions __________________________________________________________ 19 1.5.3. rapidly evolving technologies ____________________________________________ 19 1.5.4. Exclusions __________________________________________________________ 20
1.6. Establishing criteria of acceptability have been met ___________________________ 20
2. DIAGNOSTIC RADIOLOGY ____________________________________________________ 23
2.1. Introduction ____________________________________________________________ 23
2.2. X-Ray Generators and equipment for General Radiography ____________________ 24 2.2.1. Introduction _________________________________________________________ 24 2.2.2. Criteria for X-Ray Generators, and General Radiography _____________________ 27
2.3. Radiographic Image Receptors and Viewing Facilities _________________________ 30 2.3.1. Introduction _________________________________________________________ 30 2.3.2. Criteria for Image Receptors and Viewing Facilities __________________________ 32
2.4. Mammography __________________________________________________________ 38 2.4.1. Introduction _________________________________________________________ 38 2.4.2. Measurements _______________________________________________________ 39
2.5. Dental Radiography ______________________________________________________ 42 2.5.1. Introduction _________________________________________________________ 42 2.5.2. Intra-Oral Systems ____________________________________________________ 42 2.5.3. Criteria for Dental Radiography __________________________________________ 43 2.5.4. Panoramic radiography ________________________________________________ 44 2.5.5. Cephalometry _______________________________________________________ 44
2.6. Fluoroscopic Systems ___________________________________________________ 45 2.6.1. Introduction _________________________________________________________ 45 2.6.2. Criteria for Acceptability of Fluoroscopy Equipment __________________________ 46
2.7. Computed Tomography __________________________________________________ 47 2.7.1. Introduction _________________________________________________________ 47 2.7.2. Criteria for Acceptability of CT Systems ___________________________________ 49
2.8. Dual Energy X-ray Absorptiometry _________________________________________ 50 2.8.1. Introduction _________________________________________________________ 50 2.8.2. Acceptability Criteria for DXA Systems ____________________________________ 50
3. NUCLEAR MEDICINE EQUIPMENT _____________________________________________ 51
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3.1. Introduction ____________________________________________________________ 51
3.2. Nuclear Medicine Therapeutic Procedures ___________________________________ 53 3.2.1. Introduction _________________________________________________________ 53 3.2.2. Activity Measurement Instruments _______________________________________ 54 3.2.3. Contamination Monitors ________________________________________________ 54 3.2.4. Patient Dose Rate Measuring Instruments _________________________________ 55 3.2.5. Radiopharmacy Quality Assurance Programme _____________________________ 56
3.3. Radiopharmacy for Gamma Camera based Diagnostic Procedures ______________ 57 3.3.1. Introduction _________________________________________________________ 57 3.3.2. Activity Measurement Instruments _______________________________________ 58 3.3.3. Gamma Counters ____________________________________________________ 58 3.3.4. Thin Layer Chromatography Scanners ____________________________________ 59 3.3.5. Contamination monitors ________________________________________________ 59
3.4. Radiopharmacy for Positron Emission Based Diagnostic Procedures ____________ 60
3.3 Gamma Camera based Diagnostic Procedures _______________________________ 60 3.3.1 Introduction ___________________________________________________________ 60 3.4.1. Planar Gamma Camera ________________________________________________ 61 3.4.2. Whole Body IMAGING System __________________________________________ 62 3.4.3. SPECT System ______________________________________________________ 63 3.4.4. Gamma Cameras used for Coincidence Imaging ____________________________ 64
3.5. Positron Emission Diagnostic Procedures ___________________________________ 65 3.5.1. Introduction _________________________________________________________ 65 3.5.2. Positron Emission Tomography System ___________________________________ 66 3.5.3. Hybrid Diagnostic Systems _____________________________________________ 67
3.4 Intra-Operative Probes ___________________________________________________ 68
4 RADIOTHERAPY ____________________________________________________________ 70
3.6. Introduction ____________________________________________________________ 70
3.3 Linear accelerators ______________________________________________________ 71
3.7. Simulators _____________________________________________________________ 74
3.8. CT Simulators __________________________________________________________ 77
3.9. Cobalt-60 units __________________________________________________________ 80
3.10. Kilovoltage Units ______________________________________________________ 82
3.11. Brachytherapy ________________________________________________________ 83
3.12. Treatment Planning Systems ____________________________________________ 84
3.13. Dosimetry Equipment __________________________________________________ 85
3.14. Radiotherapy Networks ________________________________________________ 86
APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE _______________________ 89
APPENDIX 2 AUTOMATIC EXPOSURE CONTROL ____________________________________ 90
APPENDIX 3 EQUIPMENT _________________________________________________________ 91
REFERENCES & SELECTED BIBLIOGRAPHY ________________________________________ 93
ACKNOWLEDGEMENTS _________________________________________________________ 104
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1. INTRODUCTION
1.1. PURPOSE AND BACKGROUND
The purpose of this publication is to specify minimum performance standards for
radiological, nuclear medicine and radiotherapy equipment. The criteria of
acceptability presented here are based on levels of performance that prompt
intervention and will result in the use of the equipment being curtailed or terminated,
if not corrected. The criteria are produced in response to Directive 97/43/Euratom,
which requires that medical exposures be justified and carried out in an optimized
fashion. To give effect to this Directive, Article 8.3 stipulates that Member States
shall adopt criteria of acceptability for radiological equipment in order to indicate
when action is necessary, including, if appropriate, taking the equipment out of
service. In 1997, the Commission published Radiation Protection 91: Criteria for
acceptability of radiological (including radiotherapy) and nuclear medicine
installations (EC, 1997), in pursuit of this objective. This specified minimum criteria
for acceptability and has been used to this effect in legislation, codes of practice and
by individual professionals throughout the member states and elsewhere in the world.
RP 91 considered diagnostic radiological installations including conventional and
computed tomography, dental radiography, and mammography, radiotherapy
installations and nuclear medicine installations. However, development of new
radiological systems and technologies, improvements in traditional technologies and
changing clinical/social needs have created circumstances where the criteria of
acceptability need to be reviewed to ensure the principles of justification and
optimization are upheld. To give effect to this, the Commission, on the advice of the
Article 31 Group of Experts, initiated a study aimed at reviewing and updating RP 91
(EC, 1997), which in due course has led to this publication.
This revised publication is, among other features, intended to:
1. Update existing acceptability criteria.
2. Update and extend acceptability criteria to new types of installations. In diagnostic
radiology, the range and scope of the systems available has been greatly
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extended (e.g. computed radiography, digital radiography, digital fluoroscopy,
multislice computed tomography (CT) and dual energy x-ray absorptiometry
(DXA)). In nuclear medicine, there are Positron Emission Tomography (PET)
systems and hybrid scanners. In radiotherapy, there are linear accelerators with
multileaf collimators capable of intensity modulated radiotherapy (IMRT).
3. Identify an updated and more explicit range of techniques employed to assess
criteria of acceptability,
4. Provide criteria that have a reasonable opportunity of being accepted, and that
are achievable throughout the member states.
5. Deal, where practical, with the implications for screening techniques, paediatrics,
high dose techniques and other special issues noted in the 1997 Directive.
6. Promote approaches based on an understanding of and that attempt to achieve
consistency with those employed by the Medical Devices Directive (MDD)
(Council Directive 93/42/EEC), industry, standards organizations and professional
bodies.
7. Make practical suggestions on implementation and verification.
To achieve this, the development and review process has involved a wide range of
individuals and organizations, including experts from relevant professions,
professional bodies, industry, standards organizations and relevant international
organizations. It was easier to achieve the last objective with radiotherapy than with
diagnostic radiology. This is because of a long tradition of close working relationships
between the medical physics and international standards communities, which has
facilitated the development and adoption of common standards in radiotherapy. An
attempt has been made, with the cooperation of the International Electrotechnical
Commission (IEC), to import this approach to the deliberations on diagnostic
radiology and to extend it, where it already exists, in nuclear medicine.
The intent has been to define parameters essential to the assessment of the
performance of radiological medical installations and set up tolerances within which
the technical quality and equipment safety standards for medical procedures are
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ensured. The methods for performance assessment recommended generally rely on
non-invasive measurements open to the end user. This publication will benefit the
holder of radiological installations, bodies responsible for technical surveillance and
authorities charged with verifying compliance of installations with regulations on
grounds of technical safety. However, it is important to bear in mind that the present
publication follows the precedent established in RP 91, is limited to the equipment
and does not address wider issues such as those associated with, for example, the
requirements for buildings and installations, information technology (IT) systems such
as picture archiving and communication systems (PACS) and/or radiological
information systems (RIS).
1.2. BASIS FOR CRITERIA OF ACCEPTABILITY IN EUROPEAN DIRECTIVES
1.2.1. REQUIREMENTS OF THE MEDICAL EXPOSURE DIRECTIVE
The work of the European Commission in the field of radiation protection is governed
by the Euratom Treaty and the Council Directives made under it. The most
prominent is the Basic Safety Standards Directive (BSS) on the protection of
exposed workers and the public (Council Directive 80/836/Euratom), revised in 1996
(Council Directive 96/29/Euratom). Radiation protection of persons undergoing
medical examination was first addressed in Council Directive 84/466/Euratom. This
was replaced in 1997 by Council Directive 97/43/EURATOM (MED) on health
protection of patients against the dangers of ionizing radiation in relation to medical
exposure. This prescribes a number of measures to ensure medical exposures are
delivered under appropriate conditions. It makes necessary the establishment of
quality assurance programmes and criteria of acceptability for equipment and
installations. These criteria apply to all installed radiological equipment used with
patients.
The directive also deals with the monitoring, evaluation and maintenance of the
required characteristics of performance of equipment that can be defined, measured
and controlled. In particular, it requires that all doses arising from medical exposure
of patients for medical diagnosis or health screening programmes shall be kept as
low as reasonably achievable consistent with obtaining the required diagnostic
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information, taking into account economic and social factors (ALARA). Specifically,
the requirements in respect of criteria of acceptability are stated as follows:
“Competent authorities shall take steps to ensure that necessary measures are taken
by the holder of the radiological installation to improve inadequate or defective
features of the equipment. They shall also adopt specific criteria of acceptability for
equipment in order to indicate when appropriate remedial action is necessary,
including, if appropriate, taking the equipment out of service.”
Additional requirements in respect of image intensification and dose monitoring
systems are explicitly specified. These extend to all new equipment which:
“shall have, where practicable, a device informing the practitioner of the quantity of
radiation produced by the equipment during the radiological procedure.”
Finally Article 9 requires that:
“Appropriate radiological equipment ----- and ancillary equipment are used for the
medical exposure
of children,
as part of a health screening programme,
involving high doses to the patient, such as interventional radiology, computed
tomography or radiotherapy.”
And that:
“Special attention shall be given to the quality assurance programmes, including
quality control measures and patient dose or administered activity assessment, as
mentioned in Article 8, for these practices.”
Practical consequences of these requirements are that:
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1. Acceptance testing must be carried out before the first use of the equipment
for clinical purposes to ensure it complies with its performance specification
and to provide reference values for future performance testing.
2. Further performance testing must be undertaken on a regular basis, and after
any major maintenance procedure.
3. Necessary measures must be taken by the holder of the radiological
installation to improve inadequate or defective features of the equipment.
4. Competent authorities must adopt specific criteria of acceptability for
equipment in order to indicate when appropriate action is necessary, including
taking the equipment out of service.
5. Appropriate quality assurance programmes including quality control measures
must be implemented by the holder of the radiological installation.
This publication deals with the first four points and will be germane to some aspects
of the fifth. It updates and extends the advice provided in 1997 in RP 91 (EC, 1997).
However, this document is not intended to act as a guide to quality assurance or
quality control programmes, which are comprehensively dealt with elsewhere (CEC
2006; APPM 2006a, b; IPEM 2005a, b; AAPM 2002; BIR 2001; Seibert 1999; IPEM,
1997a, b, c).
1.2.2. WIDER CONTEXT, THE MDD DIRECTIVE AND EQUIPMENT STANDARDS
Since 1993, safety aspects of design, manufacturing and placing on the market of
medical devices are dealt with by MDD. It is managed by the European Directorate
General Enterprise; its main goal is to define and list the Essential Requirements,
which must be fulfilled by Medical Devices. When such a device is in compliance
with the Essential Requirements of the MDD, it can be “CE marked”, which opens the
full European market to the product.
There are a number of ways with which manufacturers can demonstrate that their
products meet the Essential Requirements of the MDD; the one of most interest here
involves international standards. Further, demonstration of conformity with the
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essential requirements must include a clinical evaluation. Any undesirable side-
effects must constitute an acceptable risk when weighted against the performance
intended. For the types of system that are the subject of this publication,
demonstration of the essential requirements can be achieved by the procedures
described in the directive annexes. Conformity of all or part of these requirements
can be demonstrated or verified through compliance with harmonised international
standards. These are standards that specify essential requirements for the basic
safety and essential performance of the device, such as those issued by the IEC or
Comité Européen de Normalisation Electrotechnique (CENELEC).
Although the MDD includes requirements for devices emitting ionising radiation, this
does not affect the authorisations required by the directives adopted under the
Euratom treaty when the device is brought into use. In this regard, the Euratom
Treaty directives have precedence over the MDD. Conformity with an IEC or
CENELEC standard will frequently be included as part of the suppliers‟ specification
and will be confirmed during contractual acceptance (acceptance testing) of the
equipment by the purchaser. On the other hand the acceptability criteria in this
publication must be met during the useful life of the equipment and its compliance
with them will generally be regularly assessed.
The MDD was substantially amended by Directive 2007/47/EC. The amendments
include an undertaking by the manufacturer to institute and keep up to date a
systematic procedure to review experience gained from devices in the post-
production phase and to implement appropriate means to apply any necessary
corrective action. Furthermore, the clinical evaluation and its documentation must
be actively updated with data obtained from the post-market surveillance. Where
post-market clinical follow-up as part of the post-market surveillance plan for the
device is not deemed necessary, this must be duly justified and documented.
In transposing these European directives into national law, the acceptability criteria
required by the MED may be transposed into national law using country specific
criteria and approaches. It is clear that this may undermine the applicability essential
performance standards as required by the MDD or through compliance with the
international standardisation system. Such an approach conflicts with the concept of
free circulation and suppression of barriers to trade, which is one of the goals of the
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EU in general and the MDD in particular. To avoid these difficulties there is an
urgent and clear need for harmonisation between the requirements of the two
directives (MDD and MED). Thus it is desirable that all EU countries both transpose
the MED requirement for criteria of acceptability in a consistent fashion that will not
harm the efforts under the MDD, the standards and CE marking systems, to ensure
free circulation of goods and suppress trade barriers. The approach advocated in
this publication is consistent with this objective.
Thus, care must be exercised transposing the requirements of the MED based on
either partial or inappropriate adoption of this publication as national legislation.
Where this is envisaged, some caution is necessary and due discretion must be
allowed in respect of the clinical situations envisaged in this introduction and the
associated technology specific sections. Furthermore, adopting a regulation based
solely on national radiation protection considerations without due regard for the
issues arising from the MDD is likely to prove counterproductive for both suppliers
and end users. At a national level, the solution adopted should ensure patient safety
while fostering a cooperative framework between industry, standards, end users and
regulators. Internationally, there is a clear need for harmonization and a level of
uniformity between countries in recognition of the global nature of the equipment
supply industry. It is further necessary that there be harmonization between industry
and users, at least in terms of the methodologies employed.
1.3. TO WHOM THIS DOCUMENT IS ADDRESSED
Regulatory documents and standards, with respect to equipment performance, can
be addressed to or focused primarily on the needs or obligations of a particular
group. For example, the standards produced by IEC and CENELEC are primarily
aimed at manufacturers and suppliers. Many of the tests they specify are type tests
that could not be done in the field.
However, the possible audiences for this publication include holders, end users,
regulators, industry and standards organizations. It is recognized that each of these
has a necessary interest in this publication and its application. It was recognized that
the primary audience for the publication is the holders and end-users of the
equipment (specifically, the health agencies, hospitals, other institutions,
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practitioners, medical physicists and other staff and agents, who deploy the
equipment for use with patients). In addition, it was recognized that it must reflect the
requirements of regulators when they are acting in the medical area in the interests
of end users and/or patients. This is in keeping with the precedent implicitly
established through the scope and format adopted for RP 91. This publication
addresses the needs of these groups while taking due account of the reality of
globalization of the industry, standards and the harmonization objectives viz a viz the
MDD noted elsewhere. The technical parts of Sections 2, 3, and 4 assume those
reading and using them are familiar with this introduction and have a good working
knowledge of the relevant types of equipment and appropriate testing regimes.
1.4. CRITERIA OF ACCEPTABILITY
1.4.1. APPROACHES TO CRITERIA
Approaches to describing the acceptability and performance of equipment have
varied. They inevitably include requirements specifically prescribed in the directive,
such as:
“In the case of fluoroscopy, examinations without an image intensification or
equivalent techniques are not justified and shall therefore be prohibited”,
or,
“Fluoroscopic examinations without devices to control the dose rate shall be limited
to justified circumstances.”
With respect to other areas, they range from provision of hard numerical values for
performance indices to detailed specification of measurement methodologies without
indicating the performance level to be accepted. The latter approach has come to be
favoured in many of the standards issued by bodies like IEC or CENELEC and by
some professional bodies.1 While this approach has the advantage that it is
1 The IEC is the world's leading organization that prepares and publishes International Standards for all electrical, electronic and
related technologies. IEC standards cover a vast range of technologies, including power generation, transmission and distribution to home appliances and office equipment, semiconductors, fibre optics, batteries, and medical devices to mention just a few. Many, if not all, of the markets involved are global. Within the EU CENELEC is the parallel standards organization and in practice adopts many IEC standards as its own aligning them within the European context.
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easier/possible to get consensus on it among the manufacturers, professions and
other interests involved, it also has some disadvantages. These include an evident
lack of transparency, associated limitations on accountability and risks of
misapplication in the hands of inexperienced users.
A comprehensive, consistent suite of approaches to performance and safety
assessment of radiological equipment has been proposed by the UK Institute of
Physics and Engineering in Medicine (IPEM, 2005a, b; IPEM, 1997a, b, c]. The
American Association of Physics in Medicine (AAPM,, 2006a, b, 2005, 2002) and
British Institute of Radiology (BIR, 2001) have also, among other professional
organizations, published much useful material. The IPEM system is based on the
assumption that deviations from the baseline performance of equipment on
installation will provide an adequate means of detecting unsafe or inadequately
performing equipment. This approach is questionable within the meaning of criteria
of acceptability in the MED; if the baseline is, for one reason or another,
unsatisfactory, there are no criteria on which it can be rejected. In light of this issue,
the approach more recently favoured by IPEM and many standards organizations
has not been adopted in most instances. Where possible, the emphasis has been to
propose firm suspension levels. This is consistent with the approach adopted in
many countries, including, for example, France, Germany, Belgium, Spain, Italy,
Luxembourg and others which have adopted hard limits for performance values
based on RP 91 or other sources.
1.4.2. SUSPENSION LEVELS
A critical reading of the directive, RP 91 and the professional literature reveals some
shift or “creep” in the meaning of the terms remedial and suspension level since they
came into widespread use in the mid 1990s. In the interest of clarity, we have
redefined them in a way that is consistent with both their usage in the Directive and
their current usage, as follows:
Definition of Suspension Levels:
A level of performance that requires the immediate removal of the equipment
from use.
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Following a documented risk assessment involving the Medical Physics Expert
(MPE) and the practitioner, the suspended equipment may be considered for use in
limited circumstances. The holder and the operators must be advised in writing of the
suspension and/or the related limitation(s) in use. 2
A suspension level not being met requires that the equipment is taken out of service
immediately. Not meeting the level makes the equipment unsafe, or performance so
poor, that it would be unacceptable to society. The level is based on minimum
standards of safety and performance that would be acceptable in the EU and
represent the expert judgement of the working group and reviewers based on their
knowledge of what is acceptable among their peers and informed by the social, legal
and political circumstances that prevail in the EU. When suspension levels are
reached the equipment must be removed from use (or restricted in use) with patients,
either indefinitely or until it is repaired and again satisfies the criteria.
It is also possible that the equipment will pass an evaluation based on suspension
levels but be unsatisfactory in some other way. This may be because we have
mainly considered suspension levels as performance tolerances (particularly in
radiotherapy) whereas equipment may very well fail on safety issues which are
covered by the IEC general standards 60601-1 (IEC, 2003b) and associated
collateral and particular standards. Many quality assurance manuals refer to the
levels triggering such actions as remedial levels. In line with the precedent
established in RP 91 (EC, 1997), the main thrust of this publication is concerned with
suspension levels. Remedial levels are, on the other hand, well described in
numerous quality assurance publications detailing them (AAPM, 2005; IPEM, 2005a,
b; AAPM, 2002; EC, 1997, IPEM, 1997a, b, c; et al).
Suspension levels are taken as the criteria of acceptability. They must be clearly
distinguished from the levels set for acceptance tests. The latter are used to
establish that the equipment meets the supplier‟s specification or to verify some other
contractual issue; they may be quite different from the criteria of acceptability
2 Examples of how this might arise include the following: 1.In radiotherapy, a megavoltage unit with poor isocentric accuracy
could be restricted to palliative treatment until the unit could be replaced. 2. In nuclear medicine, a rotational gamma camera with inferior isocentric accuracy could be restricted to static examinations. 3. In diagnostic radiology, an x-ray set with the beam limiting device locked in the maximum field of view position might be used to expose films requiring that format in specific circumstances.
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envisaged in the directive. However, it is entirely possible that equipment meeting
the requirements of the acceptance test will automatically pass the criteria of
acceptability. This is because the acceptance test for modern equipment will often
be more demanding than the criterion of acceptability. Tests based on the criteria of
acceptability should be performed on installation and thereafter regularly or after
major maintenance.
In practice, acceptability testing should assure the equipment tested is serviceable
and provides acceptable clinical image quality using acceptable patient radiation
doses. QA testing may involve additional elements beyond the acceptability and will
inevitably involve reporting many remedial levels. It is presumed that by the time
acceptability is considered, acceptance tests, compliance with manufacturer‟s
specifications and commissioning tests have been successfully performed.
Equipment may be significantly reconfigured during its useful life arising from
updating, major maintenance or changes in its intended use. If this is done,
appropriate new acceptability tests will be required.
1.4.3. IDENTIFYING AND SELECTING CRITERIA
It was not possible to devise a single acceptable approach to proposing values or
levels for the criteria selected. Instead a number of approaches, with varying
degrees of authority and consensus attaching to them, have been adopted and
grouped under headings A to D as follows:
Type A Criterion
This type of criterion is based on a formal national/international regulation or an
international standard.
A reasonable case can sometimes be made for using a manufacturer‟s specification
as a criterion of acceptability. For example, all CE marked equipment, which meets
specification, will either meet or exceed the essential safety standards with which the
equipment complies. Thus, testing to the manufacturer‟s specification could be taken
as a means of ensuring the criteria of acceptability are met or exceeded in the area
they address.
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A case can also be made that compliance with the relevant IEC, CENELEC or
national standards might be taken as compliance with criteria that the industry has
deemed to be essential for safety. In practice, this approach may be limited in value
as the tests required may not be within the competence of end users or service
engineers in the field. Thus different agreed approaches to verification will be
required. Development in this area is essential to the harmonization referred to
above. In particular, agreed methodology is essential in any system of equipment
testing. Standards organizations provide a useful role model in this regard, which
this publication has tried to emulate.3
Type B Criterion
This type of criterion is based on formal recommendations of scientific, medical or
professional bodies.
Where industrial standards are not available or are out of date, advice is often
available from professional bodies, notably IPEM, AAPM, NEMA, BIR, ENMS, ACR
et al. More detailed advice on testing individual systems is available from the AAPM,
earlier IPEM publications and a wide range of material published by many
professional bodies and public service organizations. Much of the material is peer
reviewed and has been a valuable source where suitable standards are not available.
Type C Criterion
This type of criterion is based on material published in well established scientific,
medical or professional journals.
Where neither standards nor material issued by professional bodies are available,
the published scientific literature has been consulted and a recommendation from the
drafting group has been proposed and submitted to expert review by referees.
Where this process led to a consensus, the value has been adopted and is
recommended below.
3 When equipment standards are developed so that their recommendations can be addressed to and accepted by both
“manufacturers and users”, the question of establishing criteria of acceptability becomes much simplified. Highly developed initiatives in this regard have been undertaken in radiotherapy (see IEC 60976 and IEC 60977). These “provide guidance to manufacturers on the needs of radiotherapists in respect of the performance of MEDICAL ELECTRON ACCELERATORS and they provide guidance to USERS wishing to check the manufacturer‟s declared performance characteristics, to carry out
(footnote continued)
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Type D Criterion
The Type D situation arises where it has not been possible to make a
recommendation. In a small residue of areas it has not been possible to make
recommendations for a variety of reasons. For example, where the technology
involved is evolving rapidly, listing a value could be counterproductive. It could
become out of date very rapidly or it could act as an inhibitor of development. In
such situations we feel the criterion of acceptability should be determined by the
institution holding the equipment based on the advice of the MPE or Radiation
Protection Adviser (RPA) as appropriate.
The criteria of acceptability proposed are identified as belonging to one or another of
these categories. In addition, at least one reference to the primary source for the
value and the method recommended is provided. Some expansion on the approach
and the rationale for the choice is provided, where deemed necessary in an
Appendix. Test methods are only fully described if they cannot be referred to in a
high quality accessible reference.
1.5. SPECIAL CONSIDERATIONS, EXCEPTIONS AND EXCLUSIONS
1.5.1. SPECIAL CONSIDERATIONS
The directive requires that special consideration be given to equipment in the
following categories:
Equipment for screening,
Equipment for paediatrics and
High dose equipment, such as that used for CT, interventional radiology, or
radiotherapy.
acceptance tests and to check periodically the performance throughout the life of the equipment”. This approach has much to offer other areas.
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The chapters and sections in the attached volumes dealing with the high dose group
(CT, interventional radiology or radiotherapy), deal comprehensively with this
requirement.
Equipment used for paediatrics and in screening programmes is often similar or
possibly identical to general purpose equipment. Where this is the case, additional
guidance for the special problems of paediatrics, such as the requirement for a
removable grid in general radiology or fluoroscopy and the special needs with regard
to CT exposure programmes are noted in the technology specific sections. The
special requirements for mammography are based on those appropriate to screening
programmes.
1.5.2. EXCEPTIONS
Exceptions to the recommended criteria may arise in various circumstances. These
include the cases cited in Section 1.2 above, where equipment compliant with safety
and performance standards that predate the criteria for acceptability has to be
assessed. In such cases, the MPE should make a recommendation to the end user
or holder, on whether or not this level of compliance is sufficient to meet the
intentions of the directive. These recommendations must take a balanced view of the
overall situation, including the economic/social circumstances, older technology etc.;
they may be nuanced in that the RPA/MPE may recommend that the equipment be
accepted subject to restrictions on its use. Likewise it is always well to remember
that acceptability criteria, as already outlined, may depend on the use(s) for which
equipment is deployed.
1.5.3. RAPIDLY EVOLVING TECHNOLOGIES
Medical imaging is an area in which many new developments are occurring.
Encouragement of development in such an environment is not well served by the
imposition of rigid criteria of acceptability. Such criteria, when rigorously enforced,
could become obstacles to development and thereby undermine the functionality and
safety they were designed to protect. In such circumstances, the MPE should
recommend to the end-user a set of criteria that are framed to be effective with the
new technology and that takes account of related longer established technologies,
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any IEC/CEN/CENELEC standards available, the manufacturer‟s recommendations,
the related scientific and professional opinion/published literature and the maxim that
the new technology should aspire to be at least as safe as existing technology it is
replacing.
1.5.4. EXCLUSIONS
Within this publication, the term “equipment” has been interpreted to mean the main
types of equipment used in diagnostic radiology, nuclear medicine and radiotherapy.
This follows the precedent established in RP 91 (EC, 1997). It is important to be
aware that the full installation is not treated. Thus, the requirements for an
acceptable physical building and shielding that will adequately protect staff, the public
and, on occasions, patients; power supplies and ventilation have not been
addressed. However, this is an area of growing concern and one in which the
requirements have changed considerably as both equipment and legislation have
changed. In addition the acceptable solutions to the new problems, arising from both
equipment development and legislation, in different parts of the world, are different.
Consequently, this area is now in need of focused attention in its own right.
Likewise, the contribution of IT networks to improving or compromising equipment
functionality can bear on both justification and optimization. This can apply to either
PACS or RIS networks in diagnostic radiology and imaging, planning and treatment
networks in radiotherapy centres. The requirements for acceptability of such
networks are generally beyond the scope of this publication, although they have been
included occasionally, for example in radiotherapy, where they are integral to the
treatment.
As already mentioned elsewhere, the publication focuses on criteria of acceptability
and it does not offer advice intended for use in routine Quality Assurance
programmes.
1.6. ESTABLISHING CRITERIA OF ACCEPTABILITY HAVE BEEN MET
The criteria of acceptability will be applied by the competent authorities in each
member state. The authorities for the MED are generally not the same as those for
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the MDD. In addition the criteria will be introduced and applied in the context of the
unfolding requirements for clinical audit in healthcare in general and in the
radiological world in particular. This is accompanied by a general increase in the
requirements for individual and institutional accreditation. Thus the holder of
radiological equipment should appoint a competent person to establish that the
criteria of acceptability have been met. The person appointed should be an MPE or
a person of similar standing. Who performs the tests to verify compliance is a matter
for local arrangements. Thus the MPE may choose to perform the tests themselves,
write them up, report on them and sign them off. Alternatively, he/she may accept
results provided by the manufacturer‟s team. These may have been acquired, for
example, during acceptance testing or commissioning. Results for tests performed to
agreed methodology will be satisfactory in many cases. They provide the information
on which the MPE can make a judgement on whether or not the equipment meets
the criteria. These two approaches represent the extremes. Most institutions will
establish a local practice somewhere between that allows the criteria to be verified
with confidence by a suitably qualified agent acting on behalf of the end user. In
radiotherapy, joint acceptance testing by the manufacturer‟s team and the holder‟s
MPE is commonplace. Whichever approach is taken, where a suspension level is
not met, the outcome and any associated recommendations from the MPE and/or the
practitioner must be communicated promptly, in writing, to both the holder and the
operators/users of the equipment.
In situations where the formally recommended criteria of acceptability are incomplete,
lack precision, or where the equipment is very old, subject to exception, special
arrangements or exemptions, the judgement and advice of the MPE becomes even
more important. Additional, more complete, measurements may be needed to
determine the cause of the change in performance. When equipment fails to meet
the criteria, agreement must be established on how it will be withdrawn from use with
patients. This must be done in association with the MPE whose advice must be
obtained. The options, in practice, include those mentioned above and include the
possibility of immediate withdrawal, where the failure of compliance is serious
enough to warrant it. Alternatively a phased withdrawal or limitations on the range of
use of the equipment may be considered. In the latter case, the specific
circumstances under which the equipment may continue to be used must be carefully
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defined and documented. In addition, the advice of the MPE to the practitioner and/or
the holder or the holder‟s representative must be made available in a prompt and
timely way, consistent with the recommendations for action.
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2. DIAGNOSTIC RADIOLOGY
The technical parts of Sections 2, 3, and 4 assume those reading and using them are
familiar with the introduction and have a good working knowledge of the relevant types of
equipment and appropriate testing regimes.
2.1. INTRODUCTION
Since RP 91 (EC, 1997), there have been a number of major developments in diagnostic
radiology. Perhaps the key new developments are the introduction of direct digital detectors
(e.g. large area flat panel detectors) for use in radiology and fluoroscopy, as well as multiple
slice computed tomography scanners. Both these new developments have implications for
acceptability criteria, but suspension levels in these areas are less mature.
Manufacturers have also incorporated information technology and other developments into
medical imaging systems which have resulted in radiological imaging equipment being
more stable. For instance, the stability of the applied tube potential produced by high
frequency generators has been much improved when compared with previous x-ray
generator designs (e.g. single phase). As equipment performance evolves, so do
acceptability criteria.
With the implementation of the quality culture within radiology departments and the
evolution of quality assurance programmes, criteria have also changed. In part the
availability of instrumentation for determination of radiation exposure in radiology linked to
computers has also impacted on measurement approaches and quality assurance.
However, in rapidly evolving areas of radiology, such as CT scanning, acceptability criteria
have not kept pace with technological developments. There is a deficit in consensus based
acceptability criteria for these areas of practice which will need to be addressed in the
future. Acceptability criteria for all types of diagnostic radiology equipment are summarised
in the following sections.
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2.2. X-RAY GENERATORS AND EQUIPMENT FOR GENERAL RADIOGRAPHY
2.2.1. INTRODUCTION
General radiographic systems still provide the great majority of X-Ray examinations. They
may be subdivided in practice into a number of subsidiary specialist types of system. This
section deals with the Suspension Levels applicable to X-Ray generators, and general
radiographic equipment. It also includes or is applicable to mobile systems, traditional
conventional tomography and tomosynthesis systems, system subcomponents/devices
such as automatic exposure control (AEC), and grids. Much of what is presented here is
also applicable to generators for fluoroscopic equipment. However, the criteria have not
been developed with specialized X-ray equipment in mind: dental, mammographic, CT and
DXA units are mentioned in sections 2.4, 2.5, 2.7, and 2.8.
The criteria here refer to X-ray tube and generator, output, filtration and half value layer
(HVL), beam alignment, collimation, the grid, AEC, leakage radiation and dosimetry.
Suspension/tolerance levels are specified in the Tables below. Before presenting them a
few aspects of half value layer and filtration, image quality, paediatric concerns, AEC,
mobile devices, and spatial resolution must be mentioned to ensure that the approach and
the Tables are interpreted correctly.
HVL/filtration
Total filtration in general radiography should not normally be less than 2.5 mm Al. The half
value layer (HVL) is an important metric used as a surrogate measurement for filtration. It
shall not be less than the values given in Table 2.1.
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Table 2.1 Minimum half-value layer (HVL) requirements
Application Values of x-ray tube
voltage. (kV)
Minimum permissible (HVL) in mm Al
(IEC 60601-1-3 (IEC, 2008a) and see Notes 1
and 2)
General
radiography x-
ray equipment
<50
50
60
70
80
90
100
110
120
>120
See note 3
1.8
2.2
2.5
2.9
3.2
3.6
3.9
4.3
see note 3
Note 1: These HVLs correspond to a total filtration of 2.5 mm Al for equipment operating at constant potential
in tungsten anode.
Note 2: Linear extrapolation to be used here.
Note 3: Test methods differ for different modalities.
Paediatric Issues
Requirements for radiography of paediatric patients differ from those of adults, partly
related to differences in size and immobilization during examination (see notes in Tables
throughout Section 2). Beam alignment and collimation are particularly important in
paediatric radiology, where the whole body, individual organs and their separation distance
are smaller. The x-ray generator and tube must have sufficient power to make short
exposure times possible. In addition the option to remove the grid from a radiography
table/image receptor is essential in a system for paediatric use, as is the capacity to disable
the AEC and use manual factors. Systems used with manual exposures (like dedicated
mobile units for bedside examinations) should have exposure charts for paediatric patients.
Image Quality and Spatial Resolution
There are unresolved difficulties in determining objective measures of image quality that are
both reproducible and reflect clinical performance. Measurements here are limited to high
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contrast bar patterns, and may be augmented by subjective or semi subjective
assessments at the discretion of the MPE and the Practitioner. (Appendix 1)
Automatic exposure control for any radiographic detector
The AEC should provide limitation of under- and overexposure of the receptor and
exposure time. Digital generators also require that pre-programmed exposure systems be
assessed to ensure acceptability based on the suppliers‟ specification and the MPE‟s
evaluation. It may also, at the discretion of the MPE, and subject to its being an agreed
part of the equipment specification with the supplier, include assessment of Ka,e for a
specific type of examination (see Table 2.2 below for radiographic detectors (method in
Appendix 2). This should be such that the Ka,e for the patient phantom is below an agreed
diagnostic reference level (DRL). In addition, the optical density of the film should be
between 1.0 and 1.5 OD (SBHP-BVZF, 2008).
Table 2.2 Examples of image receptor Ka,e for various examinations for some specific
conditions see note 1
Examination Image receptor entrance air
kerma (incl. back scatter)
Ka,e (μGy)
PMMA
thickness (cm)
Tube
voltage
(kVp)
Abdomen radiograph adult) 5 20 80
Chest radiograph (adult) 5 11 120
Chest radiograph (child) 5 8 80
Note 1: For method see Appendix 2; this also includes some information on CR and DDR.
Mobile devices
For mobile devices the criteria for equipment for general radiography are applicable except
the requirements for alignment, which cannot be met in practice.
Conventional tomography
The parameters for conventional tomography equipment include cut height level, cut plane
incrementation, exposure angle, cut height uniformity and spatial resolution.
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2.2.2. CRITERIA FOR X-RAY GENERATORS, AND GENERAL RADIOGRAPHY
Table 2.3: Criteria for Acceptability of General Radiography Systems
Physical Parameter Suspension Level Reference Type Notes (Paediatrics)
Mechanical and
electrical safety
If defects pose an
immediate mechanical
or obvious electrical
hazard to patients or
staff
IEC 60601
Series
A Mechanical and
electrical safety
failures can be the
source of accidents
X-RAY SYSTEM
x-ray tube and
generator
tube voltage
accuracy
A Lower kVp often used
in paediatrics (EC,
1996c)
Dial calibration Maximum deviation: >
± 10% or ± 10 kV
EC (1997)
IPEM (2005a)
A
B
Variation with tube
current
Maximum variation: >
± 10%
EC (1997) B
Precision of tube
voltage
Deviation > ± 5% from
mean
EC (1997) A
x-ray tube output
Magnitude of output Y(1m) > 25 μGy/mAs
at 80 kV and 2.5 mm
Al
EC (1997) A
Consistency of output Y within ± 20% of
mean
EC (1997 )
IPEM (2005a)
B
Consistency of output
for range of qualities
Y within ± 20% of
mean
IPEM (2005a) B
Half-value layer (HVL
) /total filtration
HVL or sufficient total
filtration
HVL in excess for
values in Table 8.1
IEC (2008) A Additional Cu filtration
0.1 or 0.2 mm (EC,
1996c) (A)
Exposure time
Consistency of
exposure time
Actual exposure time
>
± 20% of indicated
value for values >
100ms
EC (1997)
IPEM (2005a)
A
B
Consistency and
absolute values
required for shorter
exposures,
particularly in
paediatrics (EC,
1996c)
Alignment
x-ray/light beam
alignment
Sum of misalignment
in principle directions
> 3% of dFID
IPEM (2005a) B
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Orthogonality of x-ray
beam and image
receptor (IR)
The angle between
central beam axis and
IR ≤ 1.5º from 90º
EC (1997) A
Collimation
Collimation of x-ray
beam
x-ray beam within
borders of image
receptor
EC (1997) A
Automatic collimation X-ray beam shall not
differ by more than
2% of dFID at any side
of image receptor
Borders within IR
EC (1997) A
Grid A Grids preferably not
to be used with
children (EC, 1996c)
Grid artefacts No artefacts should be
visible
EC (1997) A
Moving grid Lamellae should not
be visible on image
EC (1997) A
AEC verification See also Appendix 2
Focal spot (FS) size
through assessment
of spatial resolution
A Smaller sizes may be
required for various
applications including
paediatrics (EC,
1996c)
Spatial resolution
(limited by FS size
and detector
characteristics)
Spatial resolution ≥
1.6 lp/mm
JORF (2007a) B DIN standard
Limitation of
overexposure
Maximal focal spot
charge < 600 mAs
EC (1997) A Much equipment is
non compliant in
practice.Should this
be modified.
Limitation of exposure
time
Maximum exposure
time: 6s
EC (1997) A
Consistency of AEC
unit
Ka may not differ by
more than 10% from
mean value
SBPH-BVZ
(2008)
B See also Appendix 2
Verification of Ka,e at
image receptor for
reference examination
See table 2.2.
1.0 < OD >1.5
SBPH-BVZ
(2008)
B See also Appendix 2
Verification of sensors
of AEC
Film density for each
sensor may not differ
by more than 0.2 OD
from mean value
SBPH-BVZ
(2008)
B For chest
examinations sensors
are different on
purpose.
See also Appendix 2
Verification of AEC at Film density for a SBPH-BVZ B See also Appendix 2
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various phantom
thicknesses
phantom thickness
differs by more than
0.3 OD from mean
value for all
thicknesses
(2008)
Verification of AEC at
various tube voltages
Film density at a tube
voltage may not differ
by more than 0.2 OD
from mean value for
all tube voltages
SBPH-BVZ
(2008)
B See also Appendix 2
Dose to plate in CR
and DDR Systems
under AEC
≥ 10 μGy/plate Walsh et al
(2008.)
C NOTE: This is double
the max normally
encountered (3-5
uGy/plate). Grid in
position for this
measurement.
AEC performance in
CR and DDR
Systems:
> 50%*
Walsh et al
(2008)
C * >50% variation
allowed for 5 cm
PMMA.
Leakage radiation
Leakage radiation Ka(1m) < 1mGy in one
hour at maximum
rating
EC (1997) A
Dosimetry
For KAP meters see
2.6
Image quality Spatial better than 2.8
lp/mm for dose < 10
μGy.
And better than 2.4
lp/mm for dose < 5
μGy.
DIN 6868-58
(2001)
B Use phantom
described in the
standard
Contrast All seven steps are
not visible
DIN 6868-58
(2001)
B Use phantom
described in the
standard
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Table 2.4: Criteria for Acceptability of Conventional Tomography Systems
Physical Parameter Suspension Level Reference Type
Cut height level Difference between indicated and measured
value < 5 mm
EC (1997) A
Cut plane incrementation Reproducibility cut height < 2 mm EC (1997) A
Exposure angle Indicated and measured angle should agree
within 5° for angles more than 30°.
Agreement better for smaller angles
EC (1997) A
Cut height uniformity Image should reveal no overlaps,
inconsistencies of exposures, or
asymmetries in motion
EC (1997) A
Spatial resolution Resolution < 1.6 lp/mm EC (1997) A
2.3. RADIOGRAPHIC IMAGE RECEPTORS AND VIEWING FACILITIES
2.3.1. INTRODUCTION
The Criteria of Acceptability and the related suspension/tolerance levels for X-Ray Films,
Screens, Cassettes, CR, DR, Automatic Film Processors, the Dark Room, Light Boxes and
the Environment for general radiography are presented in Tables 2.5 to 2.12 below. They
do not deal with the requirements for mammography or dental radiography.
A wider approach to Quality Assurance of film, film processing and image receptors of all
types is a critical part of an overall day to day quality system (IPEM, 2005a; BIR, 2001,
IPEM, 1997a; Papp, 1998). Such a system includes commissioning. Detailed
commissioning tests are covered in other publications (IPEM, 1997a).
There are some fundamental differences between CR and film/screen systems. Proper
installation and calibration of a CR system in a radiology department is extremely important.
It is also important to note that the x-ray system needs to be properly set up so that it may
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be used with CR plates. In particular, the AEC needs to be appropriately set up (Section
2.2).
Details on desirable specifications and features of CR systems as well as their proper
installation can be found in AAPM Report No 93 (2006a). These guidelines should be
followed prior to the acceptability testing of CR systems. To date, unlike film systems, there
is little guidance on the performance of CR systems, and the suspension/tolerance levels
identified will almost inevitably need adjustment in line with future evidence and guidance
(Section 1.4).
Likewise, with DDR systems, the tube and generator, workstation and /or laser printer must
be known to be working properly. When undertaking the QA of the tube and generator, it is
advisable to keep the detector out of the beam or protected by lead. As with CR little
guidance is available on Suspension/Tolerance levels and the advice given above for CR
prevails. Suspension/ tolerance levels suitable for application at the present time are
provided in Table 2.7.
Display monitors and hardcopy images have a crucial role in the diagnostic process. IPEM
notes that inadequacies in the imaging viewing area may serve to negate the benefits of
other efforts made to maintain quality and consistency. Modern radiology departments
require digital images from many modalities and from PACS systems to be viewed in many
locations. Two classes of display are used: diagnostic (systems used for the interpretation
of medical images) and review (viewing medical images for purposes other than for
providing a medical interpretation). The requirements for each are different.
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2.3.2. CRITERIA FOR IMAGE RECEPTORS AND VIEWING FACILITIES
Table 2.5 Criteria of Acceptability for Automatic Film Processors, Films, Screens, Darkrooms
and Illuminators (mammography excluded)
Physical Parameter Suspension
Level
Reference Type Notes
Automatic Film
Processor:
Base plus Fog OD > 0.3 IPEM (2005a)
IPEM (1997a)
B See also IEC 61223-
2-1 (1993c), Papp
(1988) and EC
(1997)
Speed Index 1.2 ± 0.3 IPEM (2005a)
BIR (2001)
IPEM (1997a)
B See also IEC 61223-
2-1 (1993c) and
Papp (1988).
Contrast Index 1.0 ± 0.3 IPEM (2005a)
BIR (2001)
IPEM (1997a)
B See also IEC 61223-
2-1 (1993c) and
Papp (1988).
Films, Screens,
Darkroom and
Illuminators:
Screens and
Cassettes
Visible artefacts. IPEM (2005a)
BIR (2001)
IPEM (1997a)
B See also IEC 61223-
2-2 (1993d) and EC
(1997).
Relative Speed of
Intensifying Screens
> 10% or
> 0.3 OD across
film.
IPEM (2005a)
IPEM (1997a)
B See also EC (1997).
Film Screen Contact Non-uniform
density or loss of
sharpness.
IPEM (1997a) B See also IEC 61223-
2-2 (1993d) and EC
(1997).
Dark Room Safe
Lights and Film
fogging
Evidence of film
fogging after twice
the normal Film
Handling Time.
IPEM (2005a)
BIR (2001)
AAPM (2002)
B See also IEC 61223-
2-3 (1993e).
Ambient Lighting > 100 Lux. IPEM (1997a) B See also Papp
(1988), EC (1997).
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Table 2.6 Criteria for Acceptability of Cassettes and Image Plates:
Physical Parameter Suspension Level Reference Type Notes
Condition of
cassettes and image
plates
Damage to plate IPEM (2005a) B Suppliers‟
recommendations for
method
Uniformity Gross non-uniformity
Mean ± 20%
IPEM (2005a) B 70kV, 1.0 mm copper
at tube head, an
exposure for 10µGy,
read plate under linear
algorithm.
Table 2.7 Criteria for Acceptability of CR readers see notes 1 and 2
Physical Parameter Suspension Level Reference Type Notes
Dark Noise
Agfa SAL>130
Fuji pixel value > 280
Kodak EIGP > 80
Kodak EIHR > 380
Konica pixel value <
3975
AAPM (2006a)
B Erase plates, leave
plates 5 minutes, read
under standard
conditions.
Repeat for all plate
sizes.
Linearity and system
transfer properties
Manufacturer‟s
specification
KCARE (2005a) B KCARE CR QA.
Establish system
transfer properties
equation (STP)
Dose=f(pixel value)
Erasure cycle
efficiency
Blocker visible in
second image
IPEM (2005a) B High attenuation
material
Exposure index
consistency
Indicated exposure
does not agree with
measured exposure
within 20%
KCARE (2005a) B Record detector dose
indicator and calculate
indicated exposure
using the STP equation
for all plates
Detector dose
indicator consistency
The variation in the
calculated indicated
exposures differs by
greater than 20%
between plates for a
same exposure
KCARE (2005a) B
Scaling errors > 2% IPEM (2005a) B
Blurring Blurring present KCARE (2005a) B Use contact mesh
Image quality High
Contrast Resolution
(Limiting Spatial
Resolution)
Spatial resolution
better than 2.8 lp/mm
for dose < 10 μGy.
≥ 2.4 lp/mm for dose <
5 μGy.
DIN 6868-58
(2001)
A,C Use phantom described
in the standard. Also
note AAPM, 2006a &
Walsh et al. 2008
Contrast All seven steps visible DIN 6868-58
(2001)
A,C Use phantom described
in the standard
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Low-Contrast
Resolution
Manufacturers
specifications
AAPM (2006a)
B Low contrast resolution
test object
Laser beam function Edge not continuous
the full length of the
image
AAPM (2006a)
B Steel ruler
Moiré Patterns Moiré Patterns visible KCARE (2005a) B 70kV, 1.0mm of copper
at tube head, grid in
place, plate in the
bucky at 150cm from
the focus
1. The suspension values quoted for Dark Noise were valid at the time of Publication of this document.
However as CR is an evolving technology they are subject to change.
2. This is a test that has to be done during the acceptance testing of the CR Reader in order to establish
the relationship between receptor dose and pixel value. It tests whether the X-ray generator and the
CR reader have been properly set up in order to work together correctly.
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Table 2.8 Criteria of Acceptability for DDR systems see notes 1, 2
Physical
Parameter
Suspension Level Reference Type Notes
Dark Noise
Excessive noise in the
system
IPEM (2005a ) B Image without
exposure or very low
exposure
Linearity Manufacturers
recommendation
KCARE (2005b) C Establish system
transfer properties
equation (STP)
Dose=f(pixel value)
Image retention Ghosting present KCARE (2005b) C Low exposure with
closed collimators and
detector covered with
lead apron.
Exposure Index Indicated sensitivity
indices differ by greater
than 20% of equivalent
exposure sets.
KCARE (2005b) C 70kV, 1.0 mm copper
at tube head, at least
three times for 10
µGy. Repeat for 1
µGy and 12 µGy
Uniformity
Mean ± 5% IPEM (2005a) B 70kV, 1.0 mm copper
at tube head, 10 µGy.
Scaling errors >2% IPEM (2005a) B Grid, attenuating
object of known
dimensions or lead
ruler
Uniformity of
resolution
Blurring present IPEM (2005a) B Use fine wire mesh
Image quality High
Contrast
Resolution
(Limiting Spatial
Resolution)
Spatial resolution better
than 2.8 lp/mm for dose
< 10 μGy.
≥ 2.4 lp/mm for dose <
5 μGy.
DIN 6868-58
(2001)
A,C Use phantom
described in the
standard. Also note
AAPM (2006a) &
Walsh et al. (2008)
Contrast All seven steps are
visible
DIN 6868-58
(2001)
A,C Use phantom
described in the
standard
1. This test should be done at the acceptance testing of the DDR system in order to establish the relationship between receptor dose and pixel value. This is the relationship between the generator and the detector.
2. It should be noted that a number of manufacturers have installed on their DDR equipment automatic QA software in order to carry out a number of QA tests.
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Table 2.9 Criteria of Acceptability for Diagnostic Monitors
Physical Parameter Suspension Level Reference Type
luminance ratio <200 IPEM (2005a)
AAPM (2006a)
B
luminance ratio Black baseline ±35%
White baseline ±30%
IPEM (2005a)
AAPM (2006a)
B
Distance and angle calibration –
distortion (for CRT)
10% IPEM (2005a)
RCR (2002)
SEFM-SEPR (2002)
B
Resolution Visual inspection low
and high contrast
resolution different from
baseline
IPEM (2005a)
AAPM (2006a)
B
DICOM greyscale
(GSDF= DICOM Grayscale
Standard Display Function)
GSDF ±15% IPEM (2005a)
AAPM (2006a)
B
Uniformity >40% IPEM (2005a)
AAPM (2006a)
B
Variation between adjacent
monitors
>40% IPEM (2005a)
AAPM (2006a)
RCR (2002)
B
Room illumination >25 lux IPEM (2005a)
AAPM (2006a)
B
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Table 2.10 Criteria of Acceptability for Printers
Physical Parameter Suspension Level Reference Type Notes
Optical density
consistency
Baseline ±0.30 IPEM (2005a)
BIR (2001)
IEC (1994a)
B Note also AAPM
(2006a)
Image uniformity >10% IPEM (2005a)
B Note also AAPM
(2006a)
Table 2.11 Criteria of Acceptability for Film Scanners
Physical Parameter Suspension Level Reference Type
Grayscale >10% Halpern (1995)
Lim (1996)
Meeder et al (1995)
Seibert (1999)
Trueblood (1993)
SEFM-SEPR (2002)
C
Image uniformity >10% Halpern (1995)
Lim (1996)
Meeder et al (1995)
Seibert (1999)
Trueblood (1993)
SEFM-SEPR (2002)
C
Distortion >10% Halpern (1995)
Lim (1996)
Meeder et al (1995)
Seibert (1999)
Trueblood (1993)
SEFM-SEPR (2002)
C
Spatial resolution Visual inspection low and
high contrast spatial
resolution different from
baseline
Halpern (1995)
Lim (1996)
Meeder et al (1995)
Seibert (1999)
SEFM-SEPR (2002)
C
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Table 2.12 Criteria of Acceptability for Viewing Boxes
Physical Parameter Suspension Level Reference Type Notes
Luminance < 1000 cd/m2
Mammography
< 3,000 cd/m2
> 6,000 cd/m2
IPEM (2005a) B IEC (1993f)
Uniformity >30%
Mammography < 30%
IPEM (2005a) B IEC (1993f)
Variation between adjacent
viewing boxes
>30%
Mammography < 15%
IPEM (2005a) B IEC (1993f)
Room illumination (general
radiography)
>150 lux IPEM (2005a) B IEC (1993f)
Room illumination
(mammography)
>50 lux CEC (2006) A IEC (1993f)
2.4. MAMMOGRAPHY
2.4.1. INTRODUCTION
Mammography involves the radiological examination of the breast using x-rays. Mammography is
primarily used for the detection of breast cancer at an early stage and is widely used in screening
programmes involving healthy populations. It is also used with symptomatic patients. Early
detection of breast cancer in a healthy population places particular demands on the radiological
equipment as high quality images are required at a low dose. Perhaps because of the exacting
demands of mammography, acceptability criteria are particularly well developed (IPEM, 2005b;
CEC, 2006).
Mammography should be performed on equipment designed and dedicated specifically for imaging
breast tissue. Either film/screen or digital detectors may be used. The minimum features of a
mammography unit are described in table 2.13. Table 2.14 summarises the acceptability criteria for
conventional mammography equipment and 2.15 those for digital units.
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Table 2.13 Minimum Specification of an X-ray Unit Designed for mammography
Aspect Specification
X-ray Tube Nominal Focal Spot Broad focus 0.3 (IEC, 2003a)
Small focus 0.15
AEC (Analogue Equipment) Adjustable or automatically adjusted position
Fine control of optical density
Compression Motorized
Readout of compression thickness
Grid Moving (dedicated mammography)
Focus Film Distance ≥ 60cm
2.4.2. MEASUREMENTS
Measurements to assess the performance of mammography units should be performed using a
series of test equipment, some of which are specifically designed for the purpose.
Specific Tests are outlined in the tables below. The purpose of the test and a recommended
protocol are cited, together with alternative acceptable protocols. These should form part of a
quality system (BSI, 1994).
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Table 2.14 Film Screen Mammography
Physical Parameter Suspension Level Reference Type Notes
Target Film Density OD<1.3 or >2.1 IPEM (2005a) B
Not correctable
by AEC fine
control
AEC Consistency mAs > ±5% Variation in mAs
< CEC (2006) A
AEC Thickness
Compensation
Maximum deviation in OD ≥
0.15 from value at 4cm of
PMMA or range of ODs >
0.35
CEC (2006)
AFFSAPS
(2007)
A
B
Film/Screen Contact >1 cm² poor contact CEC (2006) A
High Contrast
Resolution < 12lp/mm CEC (2006) A
Threshold Contrast > 1.5% 5-6mm CEC (2006) A
X-ray/Film Alignment > 5mm CEC (2006) A
Compression
Maximum Force > 300N
200N not achievable by
adjustment of manual
control.
CEC (2006)
A
Tube Potential > 2kV difference from set
value. IPEM (2005a) B
HVL See Table 2.16 CEC (2006) A
Compression Force
Consistency > 20N CEC (2006) A In 30S
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Table 2.15 Digital Mammography Systems
Physical
Parameter Suspension Level Reference Type Notes
AEC Consistency mAs>±5% baseline CEC (2006) A
AEC Thickness
Compensation
CNR/PMMA Thickness, with the value at
5cm being used as reference, values at
other thicknesses are 2.0cm >115%
4.5cm >103% 3.0cm >110% 5.0cm >
100% 4.0cm >105% 6.0cm > 95%
7.0cm > 90%
CEC (2006) A
Threshold Contrast > 0.85% 5-6mm > 2.35%
0.5mm > 5.45% 0.25mm CEC (2006) A
X-ray/Film
Alignment >5mm CEC (2006) A
Compression Maximum Force > 300N and
200N not reachable.
IPEM (2005a)
CEC (2006)
B
A
Tube Potential
Accuracy > 2kV difference from set value. IPEM (2005a) B
HVL See Table 2.16 CEC (2006) B
Compression
Force Consistency > 20N CEC (2006) A In 30S
Table 2.16 Typical HVL measurements for different tube voltage and target filter
combinations. (Data includes the effect on measured HVL of attenuation by a PMMA
compression plate*) (CEC, 2006)
HVL (MM Al) for target filter combination
kV Mo +30 m Mo Mo +25 m RH RH +25 m RH W +50 m RH W +0.45 m Al
25 0.33 ± 0.2 0.40 ± .02 0.38 ± .02 0.52 ± .03 0.31 ±.03
28 0.36 ± .02 0.42 ± .02 0.43 ± .02 0.54 ± .03 0.37 ±.03
31 0.39 ± .02 0.44 ± .02 0.48 ± .02 0.56 ± .03 0.42 ± .03
34 0.47 ± .02 0.59 ± .03 0.47 ± .03
37 0.50 ± .02 0.51 ± .03
* Some compression paddles are made of Lexan, the HVL values with this type of compression
plate are 0.01 mm Al lower compared with the values in the table.
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2.5. DENTAL RADIOGRAPHY
2.5.1. INTRODUCTION
Dental radiography, though often delivering a low dose, is the most frequently conducted type of x-
ray examination. This section is applicable to radiographic systems for intra oral radiography using
both film and digital detectors.
2.5.2. INTRA-ORAL SYSTEMS
The following are not acceptable for dental imaging:
- Nominal or actual tube voltage < 60kVp for DC and 65-70Kvp for AC equipment
- Mechanical timers
- Film class lower than E
- Focus skin distance for intra oral equipment < 20cm.
- Non-rectangular collimators
- Systems without audible exposure indication.
Material and results of testing dental equipment are available in Gallagher et al. (2008), EC (1997),
IEC standards, and the criteria for dental equipment adopted by EU member states (Belsuit van het
FANC, 2008; IPEM, 2008; Luxembourg Annexe 7, 2008; JORF, 2007; IEC, 2000a; IPEM, 2005a;
Directive R-08-05, 2005; SEFM-SEPR, 2002).
Where exposure settings or pre-programmed exposure protocols are provided with the equipment,
their appropriateness should be checked as part of the confirmation that the equipment is
acceptable. A distinction should be made between exposure settings for adults and children.
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2.5.3. CRITERIA FOR DENTAL RADIOGRAPHY
Table 2.17 Criteria of Acceptability for Intra-Oral Dental Equipment
Physical parameter Suspension level Reference (type) Type Notes
Film development
Developer temperature <18°C and > 40°C IPEM (2005a)
Luxembourg
Annexe 7 (2008)
B Use
Thermometer
Dark room (or desktop
day light processor)
light proof
Gross fog > 0.3 OD IPEM (2005a) B Densitometer
Reproducibility of gross
fog, speed and contrast
Gross fog > 0.3 OD;
IPEM (2005a) B Densitometer;
X-ray tube and
generator
Tube voltage accuracy Maximum deviation
± 10%
JORF (2007) A kV meter,
Indication of exposure
time
Difference between
measured exposure
time and baseline >
50%
IPEM (2005a)
EC (1997)
A, B Dosimeter
Consistency of
exposure time
EC (1997) A Dosimeter???
Dosimetry
Incident air kerma for
upper molar tooth
Ka > 4mGy JORF (2007)
Luxembourg
Annexe 7 (2008)
A Measurement
of incident air
kerma at the
tip of the
collimator
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2.5.4. PANORAMIC RADIOGRAPHY
This section is applicable to radiographic systems for panoramic dental radiography.
Table 2.18 Criteria for Acceptability of OPG Systems
Physical Parameter Suspension Level Reference Type Notes
Image quality
Characteristics of the
panoramic image
Outside manufacturer‟s
specification
D Follow
manufacturer‟s
specifications and
test object
Dosimetry
Kerma area product of a
typical clinical exposure
or calculated kerma
area product from dose
width product or
equivalent
Deviation > 35% of
indicated PKA value.
JORF
(2007)
A KAP meter or
equivalent
dosimeter.
2.5.5. CEPHALOMETRY
This section is applicable to radiographic systems for cephalometry.
In addition, cephalometric systems should:
- have X-ray beams collimated to the detector and not larger than 24cmx30cm
- have at least a distance of 150cm between focus and skin
Table 2.19 Criteria for Acceptability of Cephalometry Systems
Physical parameter Suspension level Reference Type Notes
Dosimetry
Kerma area product of a typical
clinical exposure
PKA > 80 mGycm2 JORF (2007)
Luxembourg
Annexe 7
(2008)
A PKA meter or
equivalent
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2.6. FLUOROSCOPIC SYSTEMS
2.6.1. INTRODUCTION
Fluoroscopic systems can be highly flexible and are open to a wide range of applications.
They may offer a multiplicity of modes (and sub-modes) of operation. A representative
subset of the most probable intended uses of the equipment should be identified for
acceptability testing. For example, the main “cardiac mode(s)” and associated sub-modes
might be tested in a unit whose intended application will be in the area of cardiac imaging.
If the unit is later deployed for different purposes the need for a new acceptability test will
have to be considered by the practitioner and the MPE.
In many cases fluoroscopic systems are supplied as dedicated units suitable for cardiac,
vascular, gastrointestinal or other specific applications. Powerful mobile units are available
and are generally flexible. In all cases the MPE will have to consider the intended
application of the unit and the environment in which it will be installed and used. With
respect to the X-Ray generator, many of the criteria of acceptability are similar to those
prevailing for general radiographic systems.
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2.6.2. CRITERIA FOR ACCEPTABILITY OF FLUOROSCOPY EQUIPMENT
Table 2.18 Criteria of Acceptability for Fluoroscopy and Fluorography Equipment
Physical
Parameter
Suspension Level Reference Type Notes
Mechanical –
Safety
If defects pose an
immediate mechanical
or obvious electrical-
shock (hazard to
patients or staff)
IEC (2003b)
CRCPD (2002)
A 38 cm for fixed
fluoro
30 cm for mobile
fluoro
20 cm for special
surgical fluoro
Collimation Limits Irradiated area > 1.15 ×
imaged area
IEC (2000b)
A Use radiography
Half-value layer Table 2.1 applies IEC (2000b) A Test methods are
modality specific
Patient Air Kerma
Rates, and Image
receptor input Air
Kerma Rates
The four rows BELOW
are SENTINEL
VALUES offered for
consideration
IPEM (2005a, 2002)
Martin et al (1998)
Dowling et al (2008)
O‟Connor et al
(2008)
C The four rows
BELOW are
SENTINEL
VALUES offered for
consideration
“Patient” Entrance
Dose Rate, Fluoro
Mode: (Image
Intensifier and FPD
Systems.)
> 50 mGy/min
> 100 mGy/min
O‟Connor et al
(2008)
Dowling et al (2008)
C Normal mode
smallest field size.
20 cm water or
equivalent.
Normal mode, any
field size.
Maximum (lead)
“Patient” Entrance
Dose/exposure
Digital Acquisition
Mode (Image
Intensifier and FPD
Systems.)
> 2mGy/exposure.
Cardiac Systems: >
0.2mGy/exposure
O‟Connor et al
(2008)
Dowling et al (2008)
C IPEM and Martin
protocols. Largest
field size. 20 cm
water or equivalent.
Normal from survey
is 0.03 – 0.12
mGy/exposure)
Detector Entrance
Dose Rate, Fluoro
mode :(Image
Intensifier and FPD
Systems).
> 1 μGy/sec in
continuous fluoroscopy
mode.
Cardiac Systems: >
1μGy/sec in continuous
fluoroscopy mode.
O‟Connor et al
(2008)
Dowling et al (2008)
C 2 μGy/sec quoted
in IPEM but not
seen in practice.
IPEM protocols.
Largest field size.
Normal mode.
Detector Entrance
Dose/exposure
Digital Acquisition
> 5μGy/exposure.
O‟Connor et al
(2008)
Dowling et al (2008)
C Normal from survey
0.06 – 0.2
μGy/exposure
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Mode :(Image
Intensifier and FPD
Systems.)
Cardiac Systems:
>0.5μGy/exposure.
IPEM protocols.
Largest field size.
Integrated “dose
meter” calibration
If absolute accuracy
> ±35 %
IEC (2000b)
A
High contrast
resolution and
focal-spot
Spatial Resolution: < 1
lp/mm.
For Cardiac Systems: <
1.2 lp/mm
IPEM (2005a)
B Largest Field Size.
Low contrast
detectability
Threshold Contrast: >
4%
IPEM (2005a)
B
Largest Field Size.
Systems or modes
of operation
controlled by
manually setting X-
ray factors
Radiographic generator
output conditions.
As above for High
Contrast resolution and
low-contrast
detectability.
See also Section 2.2 A
Fluoroscopic Timer Acoustic alert is not
functional or not
continuous until reset.
See also Section 2.2 A
2.7. COMPUTED TOMOGRAPHY
2.7.1. INTRODUCTION
CT examinations are among the highest dose procedures encountered routinely in
diagnostic radiology and account for up to 70 percent of diagnostic medical irradiation.
Thus it is important both in terms of individual examinations and population effects. The
design and proper functioning, and particularly the optimal use of equipment can
substantially influence CT dose. This can be particularly important when pregnant patients
or children are involved. CT scanners are under continual technical development resulting
in increasing clinical application (Nagel, 2002). In the last two decades the development of
helical and multidetector scanning modes allowed greatly enhanced technical abilities and
clinical application (Kalender, 2000).
CT scanners may be replaced for reasons that, in theory, include poor equipment
performance as demonstrated by failure to meet acceptability criteria. In practice it is also
likely that replacement may frequently be with a view to meeting increased demands on the
service, or to take advantage of new developments which enable improved diagnostics,
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faster throughput or other clinical benefits. In practice there are few (if any) examples of CT
scanners being removed from use on the basis of their failure to meet currently accepted
criteria of acceptability. This suggests that these criteria are ineffective or that
obsolescence due to rapid technological development can be an overwhelming
consideration in equipment replacement. Arising from these observations it is possible that
the available criteria, including those which follow, should be viewed with caution. A review
of the dose parameters or dose to patients for certain key procedures, and their comparison
to accepted diagnostic reference levels, is a more meaningful measure of the acceptability
of the practice using the CT scanner, but this is outside of the scope of the current
document.
CT scanners are increasingly utilised in radiotherapy in support of treatment planning
(Mutic, 2003; IPEM, 1999). They are also a component of PET-CT systems and CT
acceptability criteria can be applied to the CT component.
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2.7.2. CRITERIA FOR ACCEPTABILITY OF CT SYSTEMS
Table 2.19 Criteria of acceptability for CT Equipment see notes 1-3
1 Protocols either programmed in lookup table or in written form.
2 MPE should compare procedure dose levels with appropriate DRLs
3 applicable for equipment manufactured after 2001
4 Protocols are programmed in lookup table or in written form
5 MPE should compare procedure dose levels with appropriate diagnostic reference levels
Physical Parameter Suspension Level Reference Type Notes
CTDI, DLP /CVOL,
CW, PK.L,CT
Dose ± 20% of
manufacturer's
specifications;
IEC (2004a) A
Accessible
protocols4
should be
consistent with
good practice5
ESPECIALLY for
paediatrics.
Accuracy of indicated
dose parameters
Dose ± 20%
indicated dose A
Image noise Noise ± 25 % of
baseline. IPEM (2005a) B
Uniformity ±8 HU
CEC (2006)
B
Value
recommended in
IEC (2004a) is ±4
HU
CT number accuracy
CT number ± 20 HU
(water); ± 30 HU
(other material)
compared to baseline
values
IPEM (2005a) A
(French
standards are ±4
HU nominal or
baseline)
Artefact D
Any artefact
likely to impact
on clinical
diagnosis
Image Display and
Printing See section 2.3
Image slice width
+ 0.5 mm for <1
mm ; ±50% for 1 to
2 mm; ± 1mm
above 2 mm.
IEC (2004a) A
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2.8. DUAL ENERGY X-RAY ABSORPTIOMETRY
2.8.1. INTRODUCTION
Dual-energy X-ray Absorptiometry (DXA) is primarily used in determination of bone mineral
density; however its application has more recently been extended to include estimates of
body fat content. It is performed on equipment specifically designed for and dedicated to
these purposes. Similar examinations are performed on CT with much higher doses
(Kalender, 1995).
For comparison of scanner results and longitudinal studies the accuracy of calibration is
critical. The effect of software updates also needs to be monitored. However there are well
documented discrepancies between the results obtained on the scanners of major
manufacturers (Kelly, Slovik and Neer, 1989). Further work in this area is essential.
2.8.2. ACCEPTABILITY CRITERIA FOR DXA SYSTEMS
Table 2.20 Criteria of Acceptability for DXA Equipment
Physical Parameter Suspension Level Reference Type Notes
Patient Entrance
Dose
Less than 500 μGv for
spine examination.
Outside +/- 50%
deviation from
manufacturers
specified nominal
patient dose
Larkin et al (2008)
Njeh et al (1999)
Sheahan (2005)
C Normal from
survey is 20 –
200 μGv)
Clinical Protocol –
standard.
Worst case 35%
from Larkin paper
and 40% from
Sheahan paper.
Repeatability of
Exposures
See Section 2.2
BMD accuracy Outside 3% of
manufacturer‟s
specified BMD
Larkin et al (2008)
Sheahan (2005)
BIR (2001)
IAEA (2009)
Sheahan et al
(2005)
C Standard protocol
with supplier‟s
phantom.
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3. NUCLEAR MEDICINE EQUIPMENT
The technical parts of Sections 2, 3, and 4 assume those reading and using them are
familiar with the introduction and have a good working knowledge of the relevant types of
equipment and appropriate testing regimes.
3.1. INTRODUCTION
The safe, efficient and efficacious practice of nuclear medicine involves the integration of a
number of processes. The quality of each process will have an impact on the overall quality
of the clinical procedure and ultimately on the benefit to the patient. It is important,
therefore, that each process be conducted within the framework of a quality assurance
programme that, if followed, can be shown to achieve the desired objectives with the
desired accuracy.
The levels of activity in radiopharmaceuticals to be administered clinically are governed
primarily by the need to balance the effectiveness and the safety of the medical procedure
by choosing the minimum absorbed dose delivered to the patient to achieve the required
objective i.e. diagnostic image quality or therapeutic outcome. To realize this goal, it is
important to keep in mind that a nuclear medicine procedure consists of several
components, all of which must be controlled in order to have an optimal outcome.
Although the quality assurance of radiopharmaceuticals is an important process (IAEA,
2006), it is not an objective of this section. However, the performance testing of the
equipment needed to carry out the quality assurance of radiopharmaceuticals is an
objective, both for therapeutic and diagnostic procedures. Devices are included for the
determination of administered dose and radiochemical purity such as activity measurement
instruments (activity meter or dose calibrator), gamma counter, thin layer chromatography
scanner and high performance liquid chromatography radioactivity detector.
More specifically the objective of this section is to specify acceptable performance tolerance
levels (suspension levels) for the equipment used in Nuclear Medicine procedures, both for
gamma camera and positron emission based procedures. In-vitro Nuclear Medicine
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diagnostic equipment and instruments are not covered since these do not contribute to the
patient exposure.
Some Positron Emission Tomography Installations have in-house production of the
radiopharmaceuticals they use (e.g. FDG labelled with 18F), utilising either self-shielded
cyclotrons or cyclotrons placed in specially designed bunkers. This activity is regarded as a
radiopharmaceutical manufacturing activity and therefore is outside the scope of this report.
This section also covers the instruments needed for therapeutic procedures and intra-
operative probes, since these are used directly on the patient to trace the administered
radioactivity.
When equipment no longer meets the required performance specifications (suspension
levels), it should be withdrawn from use, may be disposed of, and replaced (Article 8 (3) of
Council Directive 97/43/Euratom). Alternatively, following a documented risk assessment
involving the MPE and the Physician, equipment may be used for less demanding tasks for
which a lower specification of performance is acceptable. The operator must be advised of
the circumstances.
The suspension levels stated are intended to assist in the decision making process
regarding the need for recalibration, maintenance or removal from use of the equipment
considered.
This section considers equipment used for:
1 Nuclear medicine therapeutic procedures
2 Radiopharmacy quality assurance programme
3 Gamma camera based diagnostic procedures
4 Positron emission diagnostic procedures
5 Hybrid diagnostic systems
6 Intra-operative probes
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Each part of this section is comprised of a brief introduction and a list of relevant
equipment. For each piece of equipment, a brief introduction, a table with the critical
performance parameters and the suspension levels are given. References to recommended
test methods for each parameter are also given.
3.2. NUCLEAR MEDICINE THERAPEUTIC PROCEDURES
3.2.1. INTRODUCTION
Unsealed radioactive sources are administered to patients orally, intravenously or injected
into various parts of the body for curative or palliation purposes. The management of the
patient depends on the activity and radionuclide used to give the prescribed absorbed dose.
It may be necessary for the patient to be confined into a specially designed room for a few
days before being released from the hospital to provide radiation protection to hospital staff
and members of the public.
When working with unsealed radioactive sources, contamination always presents a
potential hazard. Such contamination may come from persons working with the radioactive
sources or from patients who have been treated with these substances. Such
contamination presents a hazard to anybody coming into contact with it and should be
avoided if at all possible, monitored and controlled if it occurs.
The patient undergoing treatment with unsealed radioactive sources must also be checked
before he/she is released from hospital to determine that the dose rate from his/her body is
down to acceptable levels for members of the public.
Three types of equipment that are used in Nuclear Medicine therapeutic procedures are
considered in this part. These are:
Activity measurement instruments
Contamination monitors
Patient dose rate measuring instruments
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3.2.2. ACTIVITY MEASUREMENT INSTRUMENTS
Many different radionuclides are used for Nuclear Medicine therapeutic procedures. The
amount of activity to be administered to the patient must be determined accurately. Activity
measurement instruments, commonly known as Isotope Calibrators or Dose Calibrators,
must be capable of measuring the activity of a particular radionuclide (gamma or beta
emitting) accurately over a wide range of energies for correct determination of the patient
dose. They must also be capable of measuring accurately over a wide range of activities.
The performance of activity measurement instruments must be assured through a quality
assurance programme conforming to international standards (IEC, 1994c; IEC, 2006). The
suspension levels are given in Table 3.1 for each critical parameter together with the type of
criterion used and a reference to a recommended test method.
Table 3.1 Suspension Levels for Activity Measurement Instruments
Physical Parameter Suspension Level Reference Type
Background response > 1.5 X Usual
Background
IEC (2006) (section 4.1)
IEC (1994c) (section 8)
C
Constancy of instrument
response
± 10% IEC (2006) (section 4.2) C
Instrument Accuracy ± 10% IEC (1994c) (section 3) C
Instrument Linearity ± 10% IEC (2006) (section 4.3)
IEC (1994c) (section 4)
C
System reproducibility ± 10% IEC (1994c) (section 5) C
Sample volume characteristics ± 15% IEC (1994c) (section 7) C
Long-term reproducibility ± 10% IEC (1994c) (section 9) C
The suspension levels given in the above table are for instruments used for the
measurement of the activity of gamma emitting sources with energies above 100keV. If
these instruments are calibrated to measure low gamma ray energies (below 100 keV),
beta or alpha emitting sources (Siegel et al, 2004) and the instrument is suspected of
malfunctioning then a test with a relevant source needs to be carried out to confirm the
suspicion using the values in the above table.
3.2.3. CONTAMINATION MONITORS
The contamination monitor (also called area survey meter) is designed for the detection and
measurement of radioactivity (alpha, beta and gamma) on the surface of objects, clothing,
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persons etc. It is used wherever contamination by radioactive substances may be
encountered and has to be monitored routinely.
The determination of a monitor‟s (instrument‟s) performance can be at different levels of
complexity (ICRU, 1992). A more detailed level is required for the evaluation or type testing
of a particular monitor design. Once the monitor has been type tested, less extensive
procedures can be used to establish either that a given monitor has maintained its
calibration or that it has the same characteristics as the original type tested monitor (IEMA,
2004; IPSM, 1994). The complexity of the procedure depends on what information is
required and is generally intermediate between that required by a full type test and a simple
reproducibility check.
The suspension levels are given in Table 3.2 for each critical parameter of contamination
monitors together with the type of criterion used and the reference to a recommended test
method.
Table 3.2 Suspension Levels for Contamination Monitors
Physical Parameter Suspension Level Reference Type
Sensitivity > 1.2 X Usual Background IEC (2001a) (section 4.2) B
Monitor Linearity ± 20% IPSM (1994) (section 3.3)
IEC (2006) (section 4.3)
IEC (1994c) (section 4)
B
Statistical Fluctuation of
Reading
± 20% IPSM (1994) (section 3.4) B
Monitor Response Time ± 10% IPSM (1994) (section 3.5) B
Energy Dependence of
Monitor
± 20% IPSM (1994) (section 3.6) B
There is a large variation between the different types of contamination monitors. The above
suspension levels are a compromise and in some cases may be considered as too
conservative.
3.2.4. PATIENT DOSE RATE MEASURING INSTRUMENTS
A patient who has been administered with a therapeutic amount of activity of a radionuclide
becomes a radioactive source and may need to be confined in a specially designed room
for a few days before being safe to be released from hospital. The monitoring of the patient
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dose rate is very important when gamma radiation is being emitted that can irradiate other
persons at a distance from the patient. Therefore, the gamma dose rate of the patient is
measured at a standard distance and should be below the acceptable level before the
patient is released from hospital.
The performance of a patient dose rate measuring instrument must be assured through a
continuous quality assurance programme conforming to international standards (IEMA,
2004) and other commonly acceptable reports (ICRU, 1992; IPSM, 1994). The suspension
levels are given in Table 3.3 for each critical parameter.
Table 3.3 Suspension Levels for Patient Dose Rate Measuring Instruments
Physical Parameter Suspension Level Reference Type
Instrument Dose Rate
Linearity
± 20% IPSM (1994) (section 3.3)
IEC (2006) (section 4.3)
IEC (1994c) (section 4)
C
Statistical Fluctuation of
Reading
± 20% IPSM (1994) (section 3.4) C
Instrument Dose Rate
Response Time
± 10% IPSM (1994) (section 3.5) C
Energy Dependence of
Instrument
± 20% IPSM (1994) (section 3.6) C
There is a large variation between the different types of patient dose rate measuring
instruments. The above suspension levels are a compromise and in some cases may be
considered as too conservative.
3.2.5. RADIOPHARMACY QUALITY ASSURANCE PROGRAMME
The quality of the radiopharmaceutical administered to the patient has to be such that it will
not cause adverse effects to the patient, expose the patient to unnecessary radiation and at
the same time be specific for the organ of interest. As the injected radiopharmaceutical
circulates in the blood system before it is absorbed and preferentially concentrated in the
target organ/tissue, other organs/tissues of the body absorb some of the
radiopharmaceutical and therefore receive an absorbed dose related to the amount of
radiopharmaceutical. Penetrating radiation from the target organ/tissue also irradiate other
organs/tissues. Therefore, the maximum amount administered should not exceed the
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recommended local Derived Reference Levels (DRLs). Poor radiochemical purity will also
result in radioactivity going to non-target organs and irradiate them unnecessarily.
Also different radiopharmaceuticals are used depending on the imaging modality used (PET
or SPECT). Furthermore, for a specific examination there may be more than one
radiopharmaceutical that can be used to acquire the final image.
Taking the above into consideration the administered activity to the patient must be
prepared in a specially designed room, the radiopharmacy (also called the Hot Laboratory),
under a strictly controlled written procedure. The performance of the instruments used in
the preparation must be assured under a quality control programme.
The type and number of instruments required in a radiopharmacy will depend on the
number of modalities available in a Nuclear Medicine Department and the variety of
radiopharmaceuticals and procedures used. For simplicity these are divided into two
categories:
1. Radiopharmacy for gamma camera based diagnostic procedures
2. Radiopharmacy for positron emission based diagnostic procedures
In cases were both gamma camera based and positron emission modalities are available,
the radiopharmacy will need to have instruments capable for accommodating both types of
radiopharmaceuticals, either in a single instrument or different instruments for each type.
3.3. RADIOPHARMACY FOR GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES
3.3.1. INTRODUCTION
The objective of this part is to define suspension levels for the performance parameters of
the equipment needed to carry out the quality assurance programme for
radiopharmaceuticals used with gamma camera based modalities. These include devices
used for radiochemical purity determination such as the activity measurement instrument,
the gamma counter and the thin layer chromatography scanner.
The availability of the above equipment in a radiopharmacy depends on the level and
sophistication of its activities.
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For the protection of the personnel working in a radiopharmacy, instruments such as
contamination monitors are also essential. Therefore this part considers the following
instruments:
Activity Measurement Instruments
Gamma Counters
Thin Layer Chromatography Scanners
Contamination Monitors
3.3.2. ACTIVITY MEASUREMENT INSTRUMENTS
The activity measurement instruments that are used for gamma camera based diagnostic
procedures need to cover the energy range and activity range of the radiopharmaceuticals
that are used in the particular department. The quality assurance programme that must be
followed to assure their performance, as well as the suspension levels are the same as
those described in section 3.2.2, under “Activity measurement instruments”.
3.3.3. GAMMA COUNTERS
These are single “well type” gamma counters used in the radiopharmacy to measure the
activity (number of counts per second) on the paper chromatography strips used for the
radiochemical purity testing of radiopharmaceuticals. These are similar to gamma counters
for in-vitro diagnostic investigations and are used to compare the number of counts of the
different sections of the paper chromatography strips.
The performance of a gamma counter must be assured through a continuous quality
assurance programme conforming to international standards (IEC, 2009) and other
commonly accepted reports (ICRU, 1992; IPSM, 1994). The suspension levels are given in
Table 3.4 for each critical parameter of a well type gamma counter.
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Table 3.4 Suspension Levels for Well Type Gamma Counters
Physical Parameter Suspension Level Reference Type
Sensitivity > 1.5 X Usual
Background
IEC (2001a) (section 4.2) C
Instrument Dose Rate
Linearity
± 20% IPSM (1994) (section 3.3)
IEC (2006) (section 4.3)
IEC (1994c) (section 4)
C
Statistical Fluctuation of
Reading
± 20% IPSM (1994) (section 3.4) C
Instrument Dose Rate
Response Time
± 10% IPSM (1994) (section 3.5) C
Energy Dependence of
Instrument
± 20% IPSM (1994) (section 3.6) C
Sample Volume
Characteristics
± 15% IEC (1994c) (section 7) C
The above suspension levels are a compromise and in some cases may be considered as
too conservative.
Test methods that can be used to monitor a gamma counter are similar to those of patient
dose rate measuring instruments. The test method for sensitivity is similar to that of
contamination monitors. The test method for volume dependence of the well type gamma
counters is similar to that of the activity measurement instruments.
3.3.4. THIN LAYER CHROMATOGRAPHY SCANNERS
A thin layer chromatography scanner is a gamma counter that simultaneously measures or
scans the length of the paper chromatography strip and calculates automatically the count
ratio as a measure of radiochemical purity.
The suspension levels of each critical parameter of a thin layer chromatography scanner
are similar to those of a gamma counter (Table 3.4).
3.3.5. CONTAMINATION MONITORS
The contamination monitors usually encountered in a radiopharmacy take the form of
continuous room monitors for air borne contamination and for the contamination of hands
and clothes of the personnel working in the radiopharmacy. The quality assurance
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programme that must be followed to assure their performance is the same as that
described for contamination monitors (see section 3.2.3).
3.4. RADIOPHARMACY FOR POSITRON EMISSION BASED DIAGNOSTIC
PROCEDURES
The specific radioactivity of the radiopharmaceutical is an important factor to consider in
guaranteeing the quality of a PET study (Nakao et al, 2006). Chemical impurities in
radiopharmaceuticals, such as precursors and analogues contained in the preparation, may
interfere with the PET study (and may cause adverse reactions in the patient). Therefore it
is necessary to measure the specific activity and chemical impurities accurately before
administration.
Due to the very short half-lives of PET radionuclides, quality control is carried out by their
producer and they are delivered to the hospital ready for patient administration.
The instruments usually found in a hospital PET radiopharmacy are the same as those for
gamma camera based diagnostic procedure radiopharmacy (Section 3.3.1), calibrated for
the specific PET radionuclides used in a particular hospital. Additionally, in hospital
research departments, one may find instruments such as High Performance Liquid
Chromatography (HPLC), Gas Chromatography (GC) and Thin Layer Chromatography
(TLC) that are used to verify the specific activity, the radiochemical and chemical purity of
the radiopharmaceutical used (Dietzel, 2003). There are also all-in-one instrument that
perform these analyses at the same time. These analysers need to meet Good
Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulation criteria
(OECD, FDA) (Dietzel, 2003).
Currently there are no commonly acceptable suspension levels for such instruments and
therefore the manufacturer‟s recommendations for each specific instrument should be used.
3.3 GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES
3.3.1 INTRODUCTION
The gamma camera is currently available in a number of configurations capable not only of
performing simple Planar Imaging (Section 3.4.2) but also of Whole Body Imaging (Section
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3.4.3) and Single Photon Emission Computed Tomography (SPECT) (Section 3.4.4). Some
dual headed Gamma Cameras with appropriate coincidence circuits and software are also
capable of performing Positron Emission Tomography (Section 3.4.5). However, the PET
Scanner dealt with in section 3.5 is rapidly replacing such systems.
The IEC (IEC, 2005c; IEC, 2004b, 1998b, c) and the National Electrical Manufacturers
Association (NEMA) (NEMA, 2007a, b) in the USA have published relevant standards.
These are almost identical with respect to many test procedures, test objects and
radioactive sources and have been used extensively. The IEC and NEMA standards were
aimed primarily at manufacturers but are now more orientated towards user application
than previous publications making it easier to test for compliance in the field. The NEMA
Standard also includes directions for the testing of Gamma Cameras with discrete Pixel
Detectors. In this section the suspension levels are mainly related to manufacturer‟s
specifications, Type A Criteria. The NEMA standards require that the system “meet or
exceed” the manufacturer‟s specification unless the specification is considered “typical
performance”. “Typical” specifications are used when the measurement is sufficiently time-
consuming that measuring large numbers of units is difficult. For these tests greater
suspension levels have been proposed.
In addition to the standards, there are a number of publications on quality control that
provide a wealth of useful background material and detailed accounts of test methods and
phantoms for routine assessment which must be undertaken on a regular basis according
to national protocols (IPEM, 2003b; AAPM, 1995).
3.4.1. PLANAR GAMMA CAMERA
Gamma cameras are normally operated with collimators appropriate to the study being
performed. Tests performed with collimators in situ are termed „system‟ tests. Tests
performed without collimators are „intrinsic‟ tests. Since there is a large range of different
types of collimator in use and their characteristics vary from type to type and from
manufacturer to manufacturer, professional judgement may have to be called on with
respect to system tests for a particular collimator. It is important to perform system non-
uniformity tests on all collimators in clinical use in order to detect collimator damage at the
earliest opportunity (IEC, 2005b)
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Table 3.5 Suspension Levels for Planar Gamma Systems
Physical Parameter Suspension Level Reference Type
Intrinsic Spatial
Resolution
>1.05 times the
manufacturer‟s
specification
IEC (2005a), Section 4.5
NEMA (2007a), Sections 2.1 and 2.7
A
Intrinsic Spatial Non-
Linearity
>1.05 times the
manufacturer‟s
specification
IEC (2005a), Section 4.4
NEMA (2007a) Sections 2.2 and 2.7
A
Intrinsic Non-uniformity >1.05 times the
manufacturer‟s
specification
IEC (2005a), Section 4.3
NEMA (2007a), Sections 2.4 and 2.8
A
Intrinsic energy
resolution
>1.05 times the
manufacturer‟s
specification
IEC (2005a), Section 4.6
NEMA (2007a), Section 2.3
A
Multiple window spatial
registration
>1.05 times the
manufacturer‟s
specification
IEC (2005a), Section 2.5
NEMA (2007a), Section 4.7
A
Intrinsic count rate
performance in air
<0.9 times the
manufacturer‟s
specification
NEMA (2007a), Section 2.6 A
System Spatial
Resolution with scatter
>1.05 times the
manufacturer‟s
specification
IEC (2005a), Section 4.3
NEMA (2007a), Section 3.2
A
System Non-uniformity >1.05 times the
manufacturer‟s
specification
IEC (2005a), Section 4.5 A
3.4.2. WHOLE BODY IMAGING SYSTEM
The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a)
contain a limited number of tests for Whole Body Systems. Before performing these specific
tests, it is advisable that the basic tests for the Planar Gamma Camera are performed for
each detector head used for whole body imaging (Table 3.5).
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Table 3.6 Suspension Levels for Whole Body Imaging Systems
Physical Parameter Suspension Level Reference Type
Whole body non-
uniformity
>10% difference between this
and planar system uniformity
IPEM (2003b) Section 4.2.1 B
Whole Body Spatial
Resolution Without
Scatter
>1.05 times the
manufacturer‟s specification
IEC (1998c), Section 3.2
NEMA (2007a), Section 5.1
A
Scanning constancy Any deviation in mean count
rate greater than expected
from Poisson statistics
IEC (1998c), Section 3.1 A
3.4.3. SPECT SYSTEM
The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a)
both contain a section devoted to SPECT systems. The basic tests for Planar Gamma
Camera systems should be performed on each detector head used for SPECT before
commencing with the tests specific for SPECT.
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Table 3.7 Suspension Levels for SPECT Systems
Physical Parameter Suspension Level Reference Type
Centre of Rotation
(COR) and Detector
Head Tilt
COR X axis offset:
>1.05 times the
manufacturer‟s
specification
For Multiple head
systems offsets >5%
Mismatch Y axis >5%
between detectors
IEC (2004d), (1998b), Sections 3.1.1
and 3.1.2
NEMA (2007a), Section 4.1
IAEA (2007c) Section 4.3.3
IPEM (2003b) Section 5.3.2
A
Collimator Hole
Misalignment
>1.05 times the
manufacturer‟s
specification
IEC (2004d), (1998b), Section 3.2
IAEA (2007c), Section 3.3.6
IPEM (2003b) Section 5.3.3
A
SPECT System Spatial
Resolution
>1.05 times the
manufacturer‟s
specification
IEC (2004d), (1998b), Section 3.6
NEMA (2007a), Section 4.3
A
Detector to Detector
Sensitivity Variation
>1.1 times the
manufacturer‟s
specification
NEMA (2007a), Section 4.5 A
Variation of Response
with Detector Rotation
≥1.5% AAPM (1995), Section III.A.1
IPEM (2003b) Section 5.3.7
A
3.4.4. GAMMA CAMERAS USED FOR COINCIDENCE IMAGING
The basic tests for Planar Gamma Camera Systems should be performed on each detector
(Table 3.5). However, the thicker crystals required for these cameras do not perform as well
with respect to intrinsic spatial resolution as the thinner crystals intended mainly for use with
technetium-99m based radiopharmaceuticals (Table 3.8). Tolerances for the other tests are
the same as those in Table 3.6.
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Table 3.8 Suspension Levels for Coincidence Gamma Camera Systems
Physical Parameter Suspension Level Reference Type
Intrinsic Spatial
Resolution
>1.05 times the
manufacturer‟s
specification [A]
IEC (2005a), Section 4.5
NEMA (2007a), Sections 2.1 and 2.7
A
System Spatial
Resolution
>1.05 times the
manufacturer‟s
specification [A]
IEC (2005a), Section 4.3
NEMA (2007), Section 3.2
A
3.5. POSITRON EMISSION DIAGNOSTIC PROCEDURES
3.5.1. INTRODUCTION
Positron Emission Tomography (PET) is a nuclear medicine imaging technique that utilises
positron-emitting radionuclides, normally produced in a cyclotron. The most frequent clinical
indication for a PET scan today is in the diagnosis, staging, and monitoring of malignant
tumours. Other indications include assessment of neurological and cardiological disorders.
The PET technology has evolved rapidly in the past decade. Two significant advances have
greatly improved the accuracy of PET imaging:
(i) the introduction of faster scintillation crystals and electronics which permit higher
data acquisition rates, and,
(ii) the combination, in a single unit, of PET and CT scanners (“hybrid” scanners, see
section 3.6).
It is expected that the utilisation of PET will increase dramatically in the future. In some
cases it may substitute for current nuclear medicine investigations but, in general, PET will
be complementary to the use of single photon imaging with the gamma camera.
The purpose of this section is to specify Suspension levels for PET scanners to be used in
clinical imaging. Note that these technical requirements relate to clinical facilities and are
not intended to apply to research installations.
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3.5.2. POSITRON EMISSION TOMOGRAPHY SYSTEM
PET is based on the coincidence detection of two oppositely directed 511 keV photons
emitted from the annihilation of a positron with an atomic electron in vivo. The detection of
such events, known as true coincidences, is used for the reconstruction of an image
describing the in vivo distribution of a positron emitting radiopharmaceutical. Apart from
these events, there are also other types of erroneous coincidences that may be detected,
namely scattered and random coincidences. Scattered coincidences are events formed by
detection of two annihilation photons, where at least one has undergone Compton
scattering before detection (but still are detected in the energy window), while random
coincidences are formed when two photons originating from two different annihilation sites
are detected within the system‟s coincidence time window.
The performance of PET systems must be assured through a continuous quality assurance
programme conforming to international standards (IEC, 2008c; NEMA, 2007b; IEC, 2005)
and other commonly accepted reports (IAEA, 2009). The suspension levels are based on
Type A Criteria. These are given in Table 3.9 for each critical parameter of PET systems.
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Table 3.9 Suspension Levels for PET Systems
Physical Parameter Suspension Level Reference Type
Spatial Resolution FWHMobserved
>1.05*FWHMexpected
NEMA (2007b) (section 3.3) A
Sensitivity
STOT observed < 0.95*STOT expected
NEMA (2007b) (section 5.3)
IEC (2008d) (section 3.3)
IEC (2005b) (section 4.2)
A
Energy resolution REobserved > 1.05*REexpected IAEA (2007c) (section
4.1.4)
A
Scatter fraction, count
losses and random
measurements
NECobserved <NEC Recommended
SFobserved > 1.05*SFexpected
NEMA (2007b) (section 4.3)
IEC (2008d) (section 3.6)
IAEA (2007c) (section
4.1.3)
A
A
Uniformity %NUobserved >
1.05*%NUexpected
NEMA (2007b) (section 7.3) A
Image quality and
accuracy of attenuation
and scatter correction
Unacceptable visual
assessment
IAEA (2007c) (section
5.1.4)
A
Coincidence timing
resolution (TOF)
RTobserved > 1.05*RTexpected IAEA (2007c) (section
4.1.6)
A
Mechanical Tests If any mechanical part is
found to compromise the
safety of operation
C
* Expected and recommended values are the values for each parameter measured or agreed
during the acceptance testing.
FWHM = Full Width at Half Maximum
3.5.3. HYBRID DIAGNOSTIC SYSTEMS
A hybrid diagnostic system is defined as the combination of two diagnostic modalities into
one system. Examples of such systems are PET-CT, SPECT-CT, PET-MRI, etc. Usually
one modality presents functional (molecular) images and the other anatomic images. The
fusion (combination) of their images gives a higher diagnostic value than the individual
images alone.
The quality control procedures of each individual modality comprising the hybrid system are
well established and if followed as recommended, the hybrid system will operate optimally.
The suspension levels for the individual modalities are valid for the hybrid systems as well.
The only concern with hybrid systems even today, is the alignment of the imaging
modalities of the hybrid system. Here it is recommended that an independent alignment
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test, using a phantom in the place of a patient, be used at regular intervals to assure the
alignment of the modalities comprising the hybrid system (NEMA, 2007b; Nookala, 2001).
The suspension level is based on Type C Criteria and is given in Table 3.10 for the
alignment of a hybrid system.
Table 3.10 Suspension Level for the Alignment of Hybrid Systems
Physical Parameter Suspension Level Reference Type
Alignment Test of a
Hybrid System
> ± 1 pixel or ± 1
mm, whichever is
bigger
Nookala (2001)
C
3.4 INTRA-OPERATIVE PROBES
Radiotracer techniques using intra-operative gamma probes are procedures that surgeons
can use to more easily localise small tumours or lymph nodes to be removed in a surgical
procedure. Use of intra-operative probes decreases operating time, decreases patient
morbidity and improves staging accuracy. All of these can lead to improved treatment,
improved quality of life and higher long-term survival rates (Halkar and Aarsvold, 1999).
The most established type of intra-operative probe is the non-imaging gamma probe. Other
types such as imaging intra-operative probes and beta probes are less well established or
are still under development and therefore their performance parameters are less rigorously
defined. Furthermore a wide range of gamma probe systems are commercially available
with different detector material, detector sizes and collimator abilities. Various methods of
evaluation of such equipment have been proposed (NEMA, 2004; IEC, 2001a). For these
reasons suspension levels to cover all the types of intra-operative probes do not exist.
For the most common application, that of the detection of the sentinel lymph node (SLN),
minimum requirements of a gamma probe system has been recommended (Wengenmair
and Kopp, 2005; Yu et al, 2005). These were derived mainly from comparison studies of
commercially available probe systems and are presented in Table 3.11. It is recommended
that the user of a particular probe system establish a quality assurance system for the
probe system in use and establish suspension levels taking into account the manufacturer‟s
recommendations.
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Table 3.11 Suspension Levels for a SLN intra-operative gamma probe system
Physical
Parameter
Suspension Level Reference Type
Radial Sensitivity
(far field)
FWHM > 40o Wengenmair and Kopp (2005)
NEMA (2004) (section 3.9)
C
Spatial Resolution FWHM >15mm for
lymph nodes in head,
neck and
supraclavicular
region
FWHM > 20mm for
lymph nodes in
extremities, axilla and
groin
Wengenmair and Kopp (2005)
NEMA (2004) (section 3.5)
C
Sensitivity < 5.5 cps/kBq Wengenmair and Kopp (2005)
NEMA (2004) (section 3.1 – 3.4)
C
Shielding > 0,1 of minimum
system sensitivity
Wengenmair and Kopp (2005) C
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4 RADIOTHERAPY
The technical parts of Sections 2, 3, and 4 assume those reading and using them are
familiar with the introduction and have a good working knowledge of the relevant types of
equipment and appropriate testing regimes.
3.6. INTRODUCTION
The purpose of this document is to list performance parameters and their tolerances.
Specific reference is not made to safety requirements, but these need to be checked at
acceptance and after maintenance and upgrades and may result in suspension of the
equipment during operation, if not met.
These functional performance tolerances reflect the need for precision in radiotherapy and
the knowledge of what can be reliably achieved with radiotherapy equipment. The
tolerances presented must be used as suspension levels at which investigation must be
initiated, according to the definition in section 1.4.2. Where possible, it will be necessary to
adjust the equipment to bring the performance back within tolerance limits. If adjustment is
not possible, e.g. loss of isocentric accuracy, it may still be justified to use the equipment
clinically for less demanding treatments. Such a decision can only be taken after careful
consideration by the clinical team (responsible medical physics expert and radiation
oncologist) and must be documented as part of an agreed hospital policy. Alternatively it
should be suspended from use until performance is restored. Suspension from use can also
be required if the safety requirements in the relevant safety standards are not met.
In the following clauses these levels are referred to as performance tolerance levels, as this
is the terminology used in the quoted IEC standards. However, in the tables these levels
are listed as tolerance/suspension levels as they correspond also with the definition of
suspension level in section 1.4.2 and used in the other sections of this document.
The performance tolerance/suspension levels quoted in this section have been extracted
mostly from international and national standards (category type A), supplemented by
guidance from national professional bodies (category type B) (see section 1.4.3).
Tolerances are expressed in the same format (e.g. ± or maximum deviation) as originally
given in the quoted standards and guidance documents.
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All test equipment used in measuring functional performance must be well maintained,
regularly calibrated and traceable (where appropriate) to national standard laboratories.
3.3 LINEAR ACCELERATORS
IEC 60601-2-1 (1998a) is the standard which identifies those features of design that are
regarded as essential for the safe operation of the equipment and places limits on the
degradation on the performance beyond which a fault condition exists. These include
protection against electrical and mechanical hazards and unwanted and excessive radiation
hazards (i.e. dose monitoring systems, selection and display of treatment related
parameters, leakage radiation and stray radiation).
IEC 60976 (2007) and IEC 60977 (2008c) are closely related to this standard. The former
specifies test methods and reporting formats for performance tests of medical electron
accelerators for use in radiotherapy, with the aim of providing uniform methods of doing so.
The latter is not a standard per se but suggests performance values, measured by the
methods specified in IEC 60976 (2007) that are achievable with present technology.
The values given in Table 4.1 are a summary of the tolerance values in IEC 60977 (2008c)
and are based on the methodology in IEC 60976 (2007). These values are broadly
consistent with the tolerances previously specified in IPEM 81 (1999), AAPM Report 46
(1994) and CAPCA standards (2005a). For a detailed description of test methods and
conditions, please refer to the IEC and IPEM documents. A list of suggested test equipment
is included in IEC 60977 (2008c). The table is intended to include the performance
parameters of all treatment devices incorporating a linear accelerator. All tests form part of
acceptance testing. Where tests are performed routinely for quality control, suggested
frequencies of testing are given in IEC 60977 (2008c), IPEM 81 (1999), AAPM Report 46
(1994), CAPCA standards (2005a) and other national QA protocols.
In the table, “IEC” refers to IEC 60976 (2007) and 60977 (2008c) and the numbers in the
Reference column refer to the clauses in these publications. “IPEM (1999)” refers to tables
in its section 5.2.
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Table 4.1 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of a medical electron accelerator
Physical Parameter Tolerance/
Suspension
Level
Reference
(IEC (2007,
2008c) unless
stated)
Type
Uniformity of radiation fields 9
X-ray beams
Beam flatness in flattened area
(max/min ratio)
1.06
(see also IEC)
A
Beam symmetry (max/min ratio) 1.03 A
Dependence on gantry and collimator
angle
See IEC A
Beam flatness at dmax See IEC A
Wedge fields
Maximum deviation of wedge
factor
2 % IPEM (1999) B
Maximum deviation of wedge
factor with gantry angle
3 % IPEM (1999) B
Maximum deviation of wedge
angle
2° A
IMRT See IEC A
Electron beams
Beam flatness See IEC A
Dependence of flatness on gantry
and collimator angle
3 % A
Beam symmetry (max/min ratio) 1.05 A
Maximum surface dose (max/min
ratio)
1.09 See IEC A
Dose monitoring system 7
Calibration check 2 % A
Reproducibility 0.5 %
Proportionality 2 % IPEM (1999) 1% A, B
Dependence on angular position 2 % IPEM (1999) B
Dependence on gantry rotation 2 % A
Stability of calibration within day 2 % A
Stability in moving beam radiotherapy See IEC A
Depth dose characteristics See IEC 8 A
X-ray beams
Penetrative quality 2 % IPEM (1999) B
Depth dose and profile 2 % IPEM (1999) B
Electron beams A
Minimum depth of dmax 1 mm A
Practical range to 80% ratio 1.6 A
Penetrative quality 3 % or 2 mm A
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Maximum relative surface dose 100 % A
Stability of penetrative quality 1 % or 2 mm
Indication of radiation fields 10
X-ray beams A
Numerical field indication 3 mm or 1.5 %
See also IEC
A
For MLCs 3 mm or 1.5 %
See IEC
A
Light field indication 2 mm or 1 %
See also IEC
A
Centres of radiation field and
light field
2 mm or 1 %
See also IEC
A
For MLCs 2 mm or 1 %
See also IEC
A
For SRS/SRT 0.5 mm
See also IEC
A
Reproducibility 2 mm
SRS alignments 0.5 mm
See IEC
See also IPEM
(1999)
A, B
Electron beams
Light field indication 2 mm A
Collimator geometry
Parallelism of opposing edges 0.5° A
Orthogonality of adjacent edges 0.5° A
Beam centring with beam limiting
system rotation
2 mm A
Light field
Field size (10*10 cm2) 2 mm IPEM (1999) B
Illuminance (minimum) 25 lux A
Edge contrast ratio (minimum) 4.0 A
Indication of the radiation beam axis 11
On entry
X-rays 2 mm A
Electrons 4 mm A
SRS 0.5 mm A
On exit
X-rays 3 mm A
SRS 0.5 mm A
Isocentre 12
Radiation beam axis 2 mm IPEM (1999) 1
mm
A, B
Mechanical isocentre 1 mm IPEM (1999) B
Indication 2 mm
SRS 0.5 mm IPEM (1999) B
Distance indication 13
Isocentric equipment 2 mm IPEM (1999) A, B
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3mm
Non-isocentric equipment 5 mm A
Zero position of rotational scales 14
Gantry rotation 0.5° IPEM (1999) B
Roll and pitch of radiation head 0.1° A
Rotation of beam limiting system 0.5° IPEM (1999) B
Isocentric rotation of the patient support 0.5° A
Table top rotation, pitch and roll 0.5° A
Accuracy of rotation scales 1° IPEM (1999) B
Congruence of opposed radiation fields 1 mm 15
Movements of patient support 16
Vertical movements 2 mm A
Longitudinal and lateral movements 2 mm IPEM (1999) B
Isocentric rotation axis 1 mm A
Parallelism of rotational axes 0.5° A
Longitudinal rigidity 5 mm A
Lateral rigidity 0.5° and 5 mm A
Electronic imaging devices 17
Minimum detector frame time 0.5 s A
Corresponding maximum frame rate 2 / s A
Minimum signal-to-noise ratio 50 A
Maximum imager lag
Second to first frame 5 % A
Or fifth to first frame 0.3 % A
Minimum spatial resolution 0.6 lp/mm IPEM (1999) B
Detachable devices can be attached to either the treatment head or the couch. The former
include shadow trays and micro-MLCs, and the latter include devices such as stereotactic
frames, head shells, bite-blocks, etc. Where reproducible immobilisation and positioning of
the patient is required, the positional tolerance of these devices should be 2 mm in general
use and 0.5 mm for SRS.
3.7. SIMULATORS
IEC 60601-2-29 (2008b) is the standard which identifies those features of design that are
regarded as essential for the safe operation of the equipment and places limits on the
degradation on the performance beyond which a fault condition exists. These include
protection against electrical and mechanical hazards and unwanted and excessive radiation
hazards. In a similar way to IEC 60976 (2007) and 60977 (2008c) for linear accelerators,
IEC 61168 (1993a) and IEC 61170 (1993b) specify test methods and functional
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performance values for radiotherapy simulators. The functional performance requirements
of radiotherapy simulators are directly related to the radiotherapy equipment being
simulated. The performance tolerances must therefore be at least equal to those
considered appropriate for the radiotherapy equipment and in many instances must be
better in order not to add to the total positioning errors. There are some differences from
recommendations published by national physicists‟ associations (IPEM (1999), AAPM
(1994) and CAPCA standards (2005b). Where recommendations from these bodies are
adopted they are indicated in the table
The values given in Table 4.2 are a summary of the tolerance values in IEC 61170 (1993b)
and are based on the methodology in IEC 61168 (1993a). Where additional tolerances (e.g.
for MLC and SRS/SRT simulation) have been suggested in the more recent linear
accelerator standards IEC 60976 (2007) and 60977 (2008c) and IPEM (1999), these are
indicated in the table. For a detailed description of test methods and conditions, please
refer to the IEC and IPEM documents.
All tests form part of acceptance testing. Where tests are performed routinely for quality
control, suggested frequencies of testing are given in IEC 61170 (1993b), IPEM (1999),
AAPM (1994), CAPCA (2005b) standards and other national QA protocols.
In the table, “IEC” refers to IEC 61168 (1993a) and 61170 (1993b).
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Table 4.2 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of a radiotherapy simulator
Physical Parameter Tolerance/
Suspension
Level
Reference
(IEC (1993a,b)
unless stated)
Type
Indication of radiation fields
Numerical field indication 2 mm or 1.0 %
See also IEC
IPEM (1999)
A, B
For MLCs 2 mm or 1.0 % IEC (2008c,
2007)
A
Light field indication 1 mm or 0.5 %
See also IEC
A
Centres of radiation field and light
field
1 mm or 0.5 %
See also IEC
IPEM (1999) A, B
For MLCs 1 mm or 0.5 % IEC (2008c,
2007)
A
For SRS/SRT 0.5 mm IEC (2008c,
2007)
A
Reproducibility 1 mm A
SRS alignments 0.5 mm IEC (2008c,
2007)
IPEM (1999)
A, B
Delineator geometry
Parallelism of opposing edges 0.5° A
Orthogonality of adjacent edges 0.5° A
Beam centring with beam limiting
system rotation
2 mm IEC (2008c,
2007)
A
Light field
Field size (10*10 cm2) 1 mm A
Minimum illuminance 50 lux A
Minimum edge contrast ratio 4.0 A
Indication of the radiation beam axis
On entry 1 mm IPEM (1999) B
SRS 0.5 mm IEC (2008c,
2007)
A
On exit 2 mm A
SRS 0.5 mm IEC (2008c,
2007)
A
Isocentre
Radiation beam axis 1 mm
See also IEC
IPEM (1999) A, B
Mechanical isocentre 1 mm IPEM (1999) B
Indication 1 mm IPEM (1999) B
SRS 0.5 mm IPEM (1999) B
Distance indication
From isocentre 1 mm A
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From radiation source 2 mm A
Image receptor to isocentre 2 mm A
Zero position of rotational scales
Gantry rotation 0.5° IPEM (1999) B
Roll and pitch of radiation head 0.1° IEC (2008c) A
Rotation of delineator 0.5° IPEM (1999) B
Isocentric rotation of the patient support 0.5° IEC (2008c) A
Table top rotation, pitch and roll 0.5° IEC(2008c) A
Accuracy of rotation scales 1° IPEM (1999) B
Congruence of opposed radiation fields 1 mm
Movements of patient support
Vertical movements 2 mm A
Longitudinal and lateral movements 2 mm IPEM (1999) B
Isocentric rotation axis 1 mm A
Parallelism of rotational axes 0.5° A
Longitudinal rigidity 5 mm A
Lateral rigidity 0.5° and 5 mm A
Electronic imaging devices
Minimum detector frame time 0.5 s IEC (2008c,
2007)
A
Corresponding maximum frame rate 2 / s IEC (2008c,
2007)
A
Minimum signal-to-noise ratio 50 IEC (2008c,
2007)
A
Maximum imager lag
Second to first frame 5 % IEC (2008c,
2007)
A
Or fifth to first frame 0.3 % IEC (2008c,
2007)
A
Minimum spatial resolution 0.6 lp/mm IPEM (1999)
10.2.6
B
Radiographic QC
Alignment of broad and fine foci images 0.5 mm IPEM (1999) B
Fluoroscopic QC
Full radiographic and fluoroscopic tests IPEM (1999) B
Alignment of Shadow Trays 1 mm IPEM (1999) B
3.8. CT SIMULATORS
CT simulators usually comprise a wide bore CT scanner, together with an external patient
positioning and marking mechanism using projected laser lines to indicate the treatment
isocentre. This is often termed “virtual simulation”. Since this is an application of CT
scanning, there is no international standard. However quality assurance of the scanner and
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alignment system is essential to ensure that the isocentre is accurately located in the
treatment volume for subsequent treatment planning and treatment. The established
standards for CT scanners (see section 2.7) for good image quality and optimum patient
radiation dose apply. Acceptable quality assurance regimes are therefore based upon good
clinical practice. The most recent work is “Quality assurance for computed-tomography
simulators and the computed-tomography-simulation process”: (AAPM, 2003). The
tolerance limits in this report are designed to satisfy the accuracy requirements for
conformal radiotherapy and have been shown to be achievable in a routine clinical setting.
Further guidance is contained in IPEM Report 81 published in 1999. The guidance in Table
4.3 is based on these two reports. IPEM Report 81 suggests that the tests are done under
the same scanning conditions as those used clinically. Checks on image quality should
also be done after software upgrades in case they affect the calibration of the Hounsfield
Units. All tests form part of acceptance testing. Where tests are performed routinely for
quality control, suggested frequencies of testing are given in AAPM Report 83 (2003), IPEM
(1999), CAPCA (2007b) standards and other national QA protocols.
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Table 4.3 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of CT simulators
Physical Parameter Tolerance/ Suspension
Level
Reference (AAPM,2003) unless stated)
Type
Alignment of CT Gantry Lasers
With centre of the imaging plane ± 2 mm B
Parallel & orthogonal over length of laser projection
± 2 mm B
Alignment of Wall Lasers
Distance to scan plane ± 2 mm B
With imaging plane over length of laser projection
± 2 mm IPEM (1999) 1° B
Alignment of Ceiling Laser
Orthogonal with imaging plane ± 2 mm B
Orientation of Scanner Table Top
Orthogonal to imaging plane ± 2 mm B
Scales and Movements
Readout of longitudinal position of table top
± 1 mm IPEM (1999) 1 mm B
Table top indexing under scanner control ± 1 mm B
Readout of gantry tilt accuracy ± 1° B
Gantry tilt position accuracy ± 1° B
Scan Position
Scan position from pilot images ± 1 mm IPEM (1999) 1 mm B
Image Quality
Left & right registration None IPEM (1999) B
Image scaling 2 mm IPEM (1999) B
CT number/electron density verification ± 5 HU water B
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± 10 HU air ± 20 HU lung, bone
3.9. COBALT-60 UNITS
IEC 60601-2-11 (2004b) is the standard which identifies those features of design that are
regarded as essential for the safe operation of the equipment and places limits on the
degradation on the performance beyond which a fault condition exists. These include
protection against electrical and mechanical hazards and unwanted and excessive radiation
hazards (i.e. controlling timer, selection and display of treatment related parameters,
leakage radiation and stray radiation). IEC 60601-2-11 (2004b) also includes requirements
for multi-source stereotactic radiotherapy equipment.
The IEC has not published performance tolerances for cobalt-60 units. The functional
performance characteristics and tolerance values in Table 4.4 are based on those for linear
accelerators in IEC 60976/7 (2008c, 2007) with some changes for cobalt-60 units. The table
does not address multi-source stereotactic radiotherapy equipment. There are some
differences from recommendations published by national physicists‟ associations (IPEM
(1999), AAPM (1994) and CAPCA (2006a) standards). Where recommendations from
these bodies are adopted, they are indicated in the table. For a detailed description of test
methods and conditions, please refer to the documents indicated.
All tests form part of acceptance testing. Where tests are performed routinely for quality
control, suggested frequencies of testing are given in IPEM (1999), AAPM (1994), CAPCA
(2006a) standards and other national QA protocols.
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Table 4.4 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of cobalt-60 units
Physical Parameter Tolerance/
Suspension Level
Reference
(IEC (2008c)
unless stated)
Type
Uniformity of radiation fields
Beam flatness ± 3 % A
Beam symmetry ± 2 % IPEM (1999) B
Dependence on gantry and collimator
angle
See IEC 60976/7 A
Wedge fields
Maximum deviation of wedge
factor
2 % IPEM (1999) B
Maximum deviation of wedge
angle
2° A
Source position (when applicable) 3 mm AAPM (1994) B
Controlling Timer and Output
Checks
Timer check on dual timer difference 1 s IPEM (1999) B
Calibration check 2 % A
Reproducibility 0.5 % A
Proportionality 2 % A
Dependence on gantry rotation 1 % IPEM (1999) B
Stability in moving beam radiotherapy See IEC 60976/7 IEC 2007, 2008C,
Timer linearity 1 % AAPM (1994) B
Stability of timer ± 0.01 min A
Output vs field size 2 % IPEM (1999)
AAPM (1994)
B
Shutter correction 2 % IPEM (1999) B
Depth dose characteristics
Penetrative quality 1 % IPEM (1999) B
Depth dose and profile 2 % IPEM (1999) B
Indication of radiation fields
Numerical field indication 3 mm or 1.5 % IPEM (1999) 2 mm A, B
Light field indication 2 mm or 1 %
Centres of radiation field and light field 2 mm or 1 % AAPM (1994) 3
mm
A, B
Reproducibility 2 mm A
Collimator geometry
Parallelism of opposing edges 0.5° A
Orthogonality of adjacent edges 0.5° A
Beam centring with beam
limiting system rotation
2 mm A
Light field
Field size (10*10 cm2) 2 mm IPEM (1999) B
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Minimum illuminance 25 lux A
Minimum edge contrast ratio 4.0 A
Indication of the radiation beam axis
On entry 2 mm A
On exit 3 mm A
Isocentre
Radiation beam axis 2 mm IPEM (1999) 1 mm
AAPM (1994) 2
mm
A, B
Mechanical isocentre 1 mm IPEM (1999) B
Indication 2 mm A
Distance indication
Isocentric equipment 2 mm
IPEM (1999) 3 mm
AAPM (1994) 2
mm
A, B
Non-isocentric equipment 5 mm A
Zero position of rotational scales
Gantry rotation 0.5° IPEM (1999) B
Roll and pitch of radiation head 0.1° A
Rotation of beam limiting system 0.5° IPEM (1999) B
Isocentric rotation of the patient support 0.5° A
Table top rotation, pitch and roll 0.5° A
Accuracy of rotation scales 1° IPEM (1999) B
Congruence of opposed radiation
fields
1 mm A
Movements of patient support
Vertical movements 2 mm A
Longitudinal and lateral movements 2 mm IPEM (1999) B
Isocentric rotation axis 1 mm A
Parallelism of rotational axes 0.5° A
Longitudinal rigidity 5 mm A
Lateral rigidity 0.5° and 5 mm A
3.10. KILOVOLTAGE UNITS
IEC 60601-2-8 (1997a) is the standard which identifies those features of design that are
regarded as essential for the safe operation of the equipment and places limits on the
degradation on the performance beyond which a fault condition exists. These include
protection against electrical and mechanical hazards and unwanted and excessive radiation
hazards. Tests are based upon IPEM Report 81 (1999), which is based on a survey of UK
practice in 1991. Where recommendations from other bodies are adopted, they are
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indicated in the table. For a detailed description of test methods and conditions, please
refer to the IPEM (1999) and CAPCA (2005d) documents.
All tests form part of acceptance testing. Where tests are performed routinely for quality
control, suggested frequencies of testing are given in IPEM (1999) and the CAPCA (2005d)
standard.
Table 4.5 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of kilovoltage units
Physical Parameter Tolerance/
Suspension
Level
Reference
(IPEM, 1999)
unless stated)
Type
Output calibration 3 % B
Monitor chamber linearity (if present) 2 % B
Timer end error 0.01 min B
Timer accuracy 2 % B
Coincidence of light and x-ray beams 5 mm CAPCA (2005d) 2
mm
B
Field Uniformity 5 % B
HVL constancy 10 % B
Measurement of HVL 10 % B
Applicator output factors 3 % B
3.11. BRACHYTHERAPY
IEC 60601-2-17 (2004c) is the standard which identifies those features of design that are
regarded as essential for the safe operation of the equipment and places limits on the
degradation on the performance beyond which a fault condition exists. These include
protection against electrical and mechanical hazards and unwanted and excessive radiation
hazards (i.e. controlling timer, selection and display of treatment related parameters and
leakage radiation). This safety standard requires in the technical description the statement
of tolerances for radioactive source positioning, transit time and dwell time. It also limits the
value for the positioning accuracy to 2 mm relative to the specified position.
The values given in Table 4.6 are based on the tolerance values in ESTRO Booklet No. 8
(2004b), AAPM Report No. 46 (1996) and the CAPCA (2006b) standard.
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All tests form part of acceptance testing. For a detailed description of test methods and
conditions, please refer to the documents above. Where tests are performed routinely for
quality control, suggested frequencies of testing are given in the documents indicated in the
Table.
Table 4.6 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of brachytherapy equipment
Physical Parameter Tolerance/
Suspension
Level
Reference
(ESTRO, 2004B)
Type
Source calibration
Single source when only one source used
(e.g. HDR)
3 % AAPM (1994) B
Individual source in a batch
Mean of batch
(e.g. LDR or permanent implant)
5 %
3 %
B
Linear source uniformity of wire sources 5 % B
Source position 2 mm B
Applicator length 1 mm AAPM (1994) B
Controlling timer 1 % AAPM (1994) B
Transit time 1 % CAPCA (2006b) B
3.12. TREATMENT PLANNING SYSTEMS
IEC 62083 (2001b) “Requirements for the safety of radiotherapy treatment planning
systems” (RTPS) is the standard which identifies those features of design that are regarded
as essential for the safe operation of the equipment. It states that “the output of a RTPS is
used by appropriately qualified persons as important information in radiotherapy treatment
planning. Inaccuracies in the input data, the limitations of the algorithms, errors in the
treatment planning process, or improper use of output data, may represent a safety hazard
to patients should the resulting data be used for treatment purposes.” It is principally a
software application for medical purposes and is a device that is used to simulate the
application of radiation to a patient for a proposed radiotherapy treatment.
IAEA-TECDOC-1540 (2007b), addresses specification and acceptance testing of RTPSs,
using the IEC 62083 (2001a) document as a basis. This document gives advice on tests to
be performed by the manufacturer (type tests) and acceptance tests to be performed at the
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hospital (site tests). IAEA-TECDOC-1583 (2008a) addresses the commissioning of RTPSs.
Both are restricted to photon beam planning, but IMRT is not included. Criteria for the
acceptability of performance tolerances of IMRT plans, e.g. based on gamma calculations,
are an area of development and are not considered in this document. The IEC has not
published performance tolerances for RTPSs, and the tolerances for RTPS for photon
beams in table 4.7 are taken from IAEA-TECDOC-1583 (2008a), where descriptions of test
methods and conditions can also be found.
Table 4.7 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of external beam RTPSs
Physical Parameter Tolerance/
Suspension
Level
Reference
(IAEA,
2008a)
Type
Output factors at the reference point 2 % A
Homogeneous, simple geometry
Central Axis data of square and rectangular fields 2 % A
Off-axis data 3 % A
Complex geometry
Wedged fields, inhomogeneities, irregular fields,
asymmetric collimator setting;
Central and off-axis data
3 % A
Outside beam edges
In simple geometry 3 % A
In complex geometry 4 % A
Radiological field width 50% - 50% distance 2 mm A
Beam fringe / penumbra (50% - 90%) distance 2 mm A
QA for treatment planning systems is described in IAEA TRS-430 (2004a), AAPM (1998b),
ESTRO Booklet No 7 (2007a) for photon beams only and ESTRO Booklet No 8 (2007b) for
brachytherapy and the national protocols IPEM (1999) and CAPCA (2007a).
3.13. DOSIMETRY EQUIPMENT
The quality assurance of dosimetry equipment is considered by AAPM (1994), IPEM (1999)
and the CAPCA (2007c) standards. The CAPCA standard is largely based upon AAPM
(1994), but with some local measurements. IPEM (1999) has the most quantitative
measures. The tests from all reports are set out below in Table 4.8. For a detailed
description of test methods and conditions, please refer to these documents. Where tests
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are performed routinely for quality control, suggested frequencies of testing are given in
these documents.
Table 4.8 Summary of functional performance characteristics with tolerance/suspension
values for acceptance testing and quality control of dosimetry equipment
Physical Parameter Tolerance/
Suspension Level
Reference
(IPEM, 1999)
Type
Ionisation Chambers
Leakage current 0.1 % AAPM (1994) B
Linearity 0.5 % AAPM (1994) B
Radionuclide stability check ≤ 1 %
Calibration against secondary standard 1 %
Beam Data Acquisition Systems
Positional accuracy 1mm CAPCA (2000c) B
Linearity 0.5 % AAPM (1994) B
Ion recombination losses 0.5 % B
Leakage current 0.1 % AAPM (1994) 0.5 % B
Effect of RF fields 0.1 % B
Stability of compensated signal 0.2 % B
Standard percentage depth dose plot 0.5 % B
Constancy of standard percentage depth
dose plot
0.5 % B
Standard profile plot: flatness 3 % B
Standard profile plot: field size 2 mm B
Accessories
Thermometer Calibration 0.5 deg C AAPM (1994) 0.1deg C B
Barometer calibration 1 mbar B
Linear rule calibration 0.3 % AAPM (1994) B
3.14. RADIOTHERAPY NETWORKS
Modern radiotherapy techniques rely on the transfer of large quantities of data and images
and require reliable data networks for safety and consistency. Quality control largely
relates to checking the correct functionality of processes and safety software, the accuracy
of new hardware and software and the comparison of data sets, sent, received or stored.
Testing most often occurs with the introduction of new developments. Regular testing can
be valuable to check for data corruption and hardware faults.
The guidance in this section is taken from IPEM Report 93 “Guidance for the
Commissioning and Quality Assurance of a Networked Radiotherapy Department” (2006)
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and the parameters needing to be checked routinely are listed in Table 4.9 below. See
IPEM Report 93 (2006) for a full description of the methods for checking these parameters.
Reference can also be made to ISO 17799:2005 “Information Technology – Security
Techniques – Code of Practice for Information Security Management” (2005) for general
advice on information security and national data protection legislation may also be
appropriate.
No suspension levels are given in table 4.9 because functionality must be correct for the
integrity of the data and its transfer. When a loss of functionality is detected, the use of the
network should be suspended until correct functionality is restored.
Table 4.9 Operating parameters to be checked routinely
Operating Parameter
Review of changes in assets, patch history, data stored, data disclosures, uses of data,
new or changed equipment and application software
Check of security fixes for Operating Systems and applications
Check that anti-virus software is up to date and enabled appropriately
Monitor logs for unexpected activity
Monitor availability of security updates and service packs on manufacturer‟ websites
Establish and monitor physical and network boundaries. Look for changes. Check
physical controls are in place and are effective
Communication channels
Dial out: Check that dial-in is not possible after changes in system configuration or system
upgrades. Check telephone numbers are dialled correctly. Check that assigned
telephone numbers have not been altered. Check log records for all attempted
connections, times, dates and endpoints
Auto answer (dial-in): Check lists of allowed dial-in sources, allowed times and any
changes in configuration settings, dial-back settings, etc. Check logs are as expected
All: Monitor link error rates. Check the accuracy of data transmission. Check traffic
encryption operating. Check for duplicate IP addresses. Monitor traffic for the presence of
new “unexpected” protocols, promiscuous mode on interfaces or unknown devices
appearing on the network
Check physical integrity of cables and terminations. Monitor and document changes in
physical network configuration. Monitor SNMP traffic logs for significant changes
DCHP: Monitor changes in the configuration files. Test DNS/DHCP allocation is
proceeding correctly. Look for new hosts in the lease allocation logs and new additions to
the network
Check routing tables are correct for static routes and that routed and gated daemons are
functional for dynamic routes. Check for propagation of routing information outside
network boundaries
Check that firewall rules have not been altered. Check that only allowed hosts, services or
packets are going through as new devices and applications are added to interior and
exterior networks. Check firewall log for intrusion signatures
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Establish which common services are necessary and provide a means of monitoring and
controlling access to them. Check that all essential services are operational
Perform security audits of physical location of clients, servers and other critical hardware.
Review access control measures and administrative personnel lists. Monitor logs for
console access and machine reboots, looking for discrepancies
Check logs for remote access and firewall logs for inappropriate clients or protocols
Examine system logs looking for sessions that are outside expected norms
Review and update the list of OSs, versions, service packs, applications and patch levels.
Test applied patches and updates as required in accordance with manufacturer‟s
instructions
Perform checks for new MAC addresses on the network (DHCP does this automatically).
Check that unused ports are disabled and/or unpatched. Check that used ports are set to
fixed MAC addresses where possible
Check the operation and configuration of the authentication system. Check the signatures
for the configuration files. Check password change dates are operating as planned.
Check that back door or manufacturer‟s passwords are not enabled or are changed
regularly
Monitor accounts added to the system for excessive permissions. Monitor system logs for
invalid administration log-in attempts
Transfer test data and checksum. Check for the addition of new fields and data types on
host systems. For DICOM transfers, use the DICOM ECHO verification service to check
connectivity and handshaking. For HL7 transfers, check connectivity
Check backup logs for errors and omissions, and error rates to verify the media is good
and hardware is not failing. Backup policy must include a retirement age for media.
Destroy data no longer required. Practice disaster recovery regularly
Review data flows looking for new cached items. Run reports checking the coherency of
the data across the system
Check for the effect of software upgrades, new equipment added, changes in configuration
and data files. Check the signatures of significant files and update if necessary. Verify
that the change control process is working
Perform checks that permissions and shares have not changed from those expected
Monitor available space, CPU utilisation and use of swap memory on critical devices
Check NTP client logs for synchronisation failures. Check reference time sources for
offset and stability. Check that server and client time zone settings have not been
modified. Check system time against an independent time source
Check that record locking on files and databases have not been broken after any OS
changes including service packs, client set-up changes and upgrades
Data
Unique identification
Geometric integrity and scaling
Region of acceptability of data accuracy and integrity
Coordinate frame orientation and location
Patient orientation and specification within the coordinate frame
Tolerances on images with respect to
pixel values
geometric distortion
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APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE
The general purpose of medical imaging is to obtain adequate image quality at the lowest possible
radiation burden to the patient. Assessment of image quality is, therefore, important. Various
methods are available for quantification of image quality (Table DR1.1 based on ICRU Report 54,
1995).
Table A1.1 Assessment of (image) quality at various physical/medical levels
Approach Methods used
Physical (fundamental) image quality
Large-scale transfer function (characteristic curve),
spatial resolution (transfer function), noise (noise
power spectra)
Statistical decision theory Ideal observer formalism, other observers
Psychophysical approach (ROC) analysis, contrast detail method
Quality assessment using phantoms for a
specific imaging task
Specific test objects, e.g. for high and low contrast
spatial resolution
Examination of images of patients European image quality criteria (diagnostic
radiographic and CT images)
The methods range from those requiring high levels of expertise and facilities (transfer functions),
are very elaborate (ROC analysis) to methods which are in principle applicable in the field in a
department of radiology.
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APPENDIX 2 AUTOMATIC EXPOSURE CONTROL
Methodology, CR and DDR
CR, DDR and AEC
The following Tables provide additional information in connection with CR and DDR AEC.
They are complementary to the data in Section 2.2 of the text.
Table A2.1 Acceptability criteria for the AEC device (CR)
Physical parameter Suspension Level Reference Criterion Notes
Consistency between
chambers
Mean ± 20% IPEM
(2005a)
B Attenuation
material
Repeatability Mean ± 30% IPEM
(2005a)
B Attenuation
material
Consistency Mean ± 60% IPEM
(2005a)
B Attenuation
material
Image receptor dose
Speed Class 400:
> 2.5 µGy± 60%
Speed Class
200:
> 5 µGy± 60%
IPEM
(2005a)
B Dosemeter.
1mm-2mm
copper filter
Table A2.2 Acceptability criteria for AEC device (DDR)
Physical parameter Suspension
Level
Reference Criterion Method
Consistency between
chambers
IPEM (2005a) B Attenuation
material
Repeatability Mean ± 30% IPEM (2005a) B Attenuation
material
Consistency Mean ± 60% IPEM (2005a) B Attenuation
material
Image receptor dose
Manufacturers
Specification ±
60%
IPEM (2005a) B Dosemeter,
1.0mm copper.
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APPENDIX 3 EQUIPMENT
Quality Control Equipment for Radiology Calibration
Instruments should have calibration traceability. Dosimetric instrumentation should comply
with IEC (1997b) and follow international guidelines (IAEA, 2004b). Care should be taken
for measurements in the beam conditions outside of those defined by IEC (1997b) (e.g.
some situations in mammography, computed tomography and interventional radiology and
all situations involving scatter radiation). In these conditions the use of instruments with a
small energy response variation is strongly encouraged. Field (or clinical) KAP meter
calibration should be performed in situ using a calibrated reference instruments using one
of two methods as described in IAEA (2007a) and Toroi, Komppa and Kosunen (2008).
Some useful equipment
Radiographic instrumentation
Calibrated non invasive tube kVp meter (IAEA, 2007a)
Dosimeter calibrated in terms of air kerma free-in-air with specialized detectors for
measurements in different modalities (ICRU, 2005; IAEA, 2007a).
Indication of current exposure time product (on the x-ray unit or by ancillary
equipment).
Instrument calibrated for measurement of exposure time.
Auxiliary equipment
Accurate tape measure and steel rule
Aluminium filters (type 1100, purity > 99%) ranging from 0.25 mm to 2 mm (HDWA,
2000).
Lead rubber sheet(s).
Attenuator set and supports
Radio-opaque grid or equivalent
Collimation and Alignment tools: X-ray field mapping device, e.g. radiographic film,
Gafchromic film or equivalent.
Radio-opaque markers – coins or paper clips.
Small lead or copper block
Film Screen Contact Test Tool (Mesh Test Tool).
Non-mercury thermometer, with a range of 25-40 oC and an accuracy of ± 0.1oC.
Geometry test object
High contrast resolution tool (Hüttner 18)
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Phantoms
Standard CT dose phantoms, Body 32-cm PMMA, Head 16 cm PMMA
CT uniformity (water) phantoms
Slice thickness phantom; Inclined planes – axial acquisition, Thin disc or bead
Measurements to assess the performance of DXA units may have to be performed
using test equipment, some of which is specifically designed for that purpose
PMMA phantoms of 10, 12, 15, 18 and 20 cm thickness.
Standard phantom, e.g.: European Spine Phantom [7, 12], BFP [8]
Tomography
Test tool (BIR, 2001; IPEM, 1997b).
Test tool for angle of swing, i.e. a 45º foam pad, pin-hole or other appropriate test
tool (IPEM, 1997b)
Instrumentation for light and image display
Calibrated Photometer for measuring luminance and illuminance.
Test pattern Image such as SMPTE or T018-QC
Calibrated Sensitometer with 21 steps or pre-exposed sensitometry strips.
Calibrated Densitometer, accuracy of ± 0.01 OD.
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ACKNOWLEDGEMENTS
Coordinator: Dr Keith Faulkner
Diagnostic Radiology Lead: Prof Jim Malone
Nuclear Medicine Lead: Dr Stelios Christofides
Radiotherapy Lead: Prof Stephen Lillicrap
Contributors
Diagnostic Radiology
Dr Steve Balter
Dr Norbert Bischof
Dr Hilde Bosmans
Ms Anita Dowling
Aoife Gallagher
Remy Klausz
Dr Lesley Malone
Ian (Donald) Mclean
Dr Alexandra Schreiner
Dr Eliseo Vano
Colin Walsh
Dr Hans Zoetelief
Nuclear Medicine
Dr Inger-Lena Lamm
Dr Soren Mattsson
Radiotherapy
Prof Patrick Horton
Dr Inger-Lena Lamm
Dr Wolfgang Lehmann
Reviewers
Dr Tamas Porubszky
Mr S. Szekeres
Markku Tapiovaara
Kalle Kepler
Koos Geleijns
Simon Thomas PhD FIPEM
Geraldine O‟Reilly