+ All Categories
Home > Documents > HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New...

HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New...

Date post: 06-Mar-2018
Category:
Upload: nguyentram
View: 227 times
Download: 5 times
Share this document with a friend
39
TNO Quality of Life >29.0°C <19.0°C 20.0 22.0 24.0 26.0 28.0 HITU - Standardization - Metrology WHY / WHAT ?? R.T. Hekkenberg Guest at TNO, NL A standard alone is not enough
Transcript
Page 1: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

TNO Quality of Life

>29.0°C

<19.0°C

20.0

22.0

24.0

26.0

28.0

HITU - Standardization - Metrology

WHY / WHAT ??

R.T. HekkenbergGuest at TNO, NL

A standard alone is not enough

Page 2: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation

The reactions were:-You are schrunken a lot(obviously the cactus is normal sized)

-What a large cactus(obviously we were normal sized)

We clearly miss an agreement

of interpretation of sizes

2

Page 3: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation• So products may work as expected (specifications)• To show compatibility with other equipment• To avoid inferior quality• Non-standardized products may be (more) dangerous

• Helps to understand and compare research results

• Essential for Governments, Regulators, Legal professions

• Enable multi-market access, important benefit to business

• Provides a solid foundation for new technologies

3

Page 4: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation

• They contribute to the enhancement of our daily lives - often invisibly

• Usually Standards are “User confidence builders”

4

Page 5: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisationApplication of Ultrasound in MedicineUltrasound in Medicine

• Diagnostic Ultrasound• Physio Therapeutic Ultrasound• Cancer treatments (HITU)• Thrombolysis• Lithotripsy• Histotripsy• Bone repair• Drug delivery (HITU)• Foetal monitoring• Fat removal• Cosmetic surgery• Ultrasonic cleaning

ISTU, New York, 2011-04-12 5

Page 6: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation, Research

EN 45502‐1: 1997 Safety of implantable devices (pacemakers) Test: 30 minutes: ultrasound energy of 500Wm‐2 

6

Page 7: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation, Research

7

Guidance on reporting ultrasound exposure conditions for bio-effect studies,

Gail ter Haar, Adam Shaw and others in the UFSUMB,UMB Vol 37, No 2,2011

This guidance is intended to encourage a better practice among researchers

Page 8: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation, Research

8

Recommendations for studies:

A: that attempts to demonstrate correlation or lack of correlation Must include (local) ultrasound field parameters

B: preliminary (non-quantitative) studiesReport output levels quoted in the user manual or on-screen

indicationsof ‘‘output’’ or of TI or MI is acceptable

C: for any study:The measured values of any acoustic quantity should always bereported, even when these are to derive MI and TI values.

D: whenever possiblethe temperature rise in the region of interest in tissue or in a physical phantom should be determined

Page 9: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation, Research

9

Recommendations for studies:

E: AlwaysExplain fully how estimated values of in situ acoustic pressure or intensity are derived.

F: AlwaysThe transmission loss of the propagation path should be used to estimatethe relevant in situ values used for the biological effects.

G: If a TI or MI is calculated for use as an exposure quantityThe index should refer to be the “Local index” and calculated as such. The method used should be explained including a worked example.

Page 10: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Aspects related to Safety

Ultrasound system

Safety aspectsdue to

performance

Safety aspectsdue to

application

Know what ultrasound can cause

Quality & stability of performanceQA

10

Page 11: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

International Standardisation (IEC)

11

Page 12: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

International Standardisation (IEC)

12

Page 13: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Device Safety StandardsIEC 60601-1-1General requirements

13

ISO/IEC 14971Risk-Assessment

Page 14: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Device Safety StandardsIEC 60601-1-1General requirements

IEC 60601-2-37Particular Diagnostic

IEC 60601-2-5 Particular Physiotherapy

IEC 60601-2-62Particular HITU

IEC 60601-2-36Particular Lithotripsy

IEC 60601-2-2Surgical Systems

14

ISO/IEC 14971Risk-Assessment

Page 15: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Device Specs StandardsIEC 60601-1-1General requirements

IEC 60601-2-37Particular Diagnostic

IEC 60601-2-5 Particular Physiotherapy

IEC 60601-2-62Particular HITU

IEC 60601-2-36Particular Lithotripsy

IEC 60601-2-261289-1 and -2

Surgical Systems

IEC 62359requirements &

methodsIEC 61689

requirements & methods

IEC 61846requirements &

methodsIEC 61847

requirements & methods

15

Page 16: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

IEC 60601-1-1General requirements

IEC 60601-2-37Particular Diagnostic

IEC 60601-2-5 Particular Physiotherapy

IEC 60601-2-62Particular HITU

IEC 61161Ultrasonic power

IEC 62127-1Hydrophone use

IEC 62255Ultrasonic power

In HITU

IEC 62256Hydrophone use

In HITU

IEC 60601-2-36Particular Lithotripsy

IEC 62359requirements &

methodsIEC 61689

requirements & methods

IEC 61846requirements &

methodsIEC 61847

requirements & methods

IEC 60601-2-2Surgical Systems

Output Measurement Standards

16

TS-IEC 61949Non-linear

IEC 62649 TRHITU Requirements

Page 17: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Why do we need standardisation Application specific Safety Considerations

Application Safety consideration based on

Diagnostic

Physiotherapy

Thermal (TI) or Mechanical (MI) Indices

Acoustic info, Beam non uniformity andUnwanted radiation

Acoustic and beam dimensional infoTemperature measurements

Therapy (HITU)

All these need: Output & Beam characterisation

17

Page 18: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Large variety of Transducers

18

Page 19: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Large variety of Ultrasonic fields

19

Page 20: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Different types of Hydrophones

20

Page 21: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

“Standard” Labs: Hydrophone calibrationINMETRO

Reciprocity

21

PTB

Interferometry

NMIJ

CSIC NPL

NIM

FORCE

Page 22: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Output Measurement Standards

22

IEC 60601-1-1General requirements

IEC 60601-2-37Particular Diagnostic

IEC 60601-2-5 Particular Physiotherapy

IEC 60601-2-62Particular HITU

IEC 61161Ultrasonic power

IEC 62127-1Hydrophone use

IEC 62255Ultrasonic power

In HITU

IEC 62256Hydrophone use

In HITU

IEC 60601-2-36Particular Lithotripsy

IEC 62359requirements &

methodsIEC 61689

requirements & methods

IEC 61846requirements &

methodsIEC 61847

requirements & methods

IEC 60601-2-2Surgical Systems

TS-IEC 61949Non-linear

IEC 62649 TRHITU Requirements

Page 23: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Standards related to HITU

23

IEC 60601-1-1General requirements

IEC 60601-2-62Particular HITU

IEC 61161Ultrasonic power

IEC 62127-1Hydrophone use

IEC 62255Ultrasonic power

In HITU

IEC 62256Hydrophone use

In HITU

TS-IEC 61949Non-linear

IEC 62649 TRHITU RequirementsTC87 WG 6

TC87 WG 6

TC87 WG 6

TC87 WG 8

TC87 WG 14

TC87 WG 8

SC62D PT 60601-2-62

TC62 SC62A

Page 24: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Set-up of the IEC 60601-2-62 standard (1)

24

- Scope- Definitions- Essential Performance- Instructions for use- Warnings and Safety notices- Protection against Electrical Hazards- Protection against unwanted and excessive radiation HAZARDS

Ultrasonic energyUnwanted ultrasound radiationUnintended heating of tissueUnintended cavitational effects on tissue

Page 25: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Standards in the field of HITU

DEFINITION:EQUIPMENT for the generation and application of ultrasound to a patient for therapeutic purposes with the intention to destroy, disrupt or denature living tissues or non-tissue elements (liquids, bubbles, micro-caps…). The ME EQUIPMENT aims notably at making treatments through actions of ultrasound having mechanical, thermal and more generally physical, chemical or biochemical effects.

Are there major differences with other ultrasound modalities?

25

Page 26: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Essential Performance requirements lists sources of unacceptable risk

26

Free from the display of incorrect numerical values associated with the therapy to be performed.

Free from the production of unwanted ultrasound output.

Free from the production of excessive ultrasound output.

Free from the reflection of excessive ultrasonic power at the transducer-patient interface due to inadequate coupling

Free from the production of unwanted thermal or mechanical tissue damage in or distal to the REGION OF INTEREST.

Page 27: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Effects on human tissue shall be given:

27

Unintended heating of tissue

Unintended cavitational effects on tissue

• total entry power• entry effective intensity• the spatial peak temporal average intensity• the spatial peak pulse average intensity• the beam width at focus• the focal depth • the side-lobe peak temporal-average intensity

and its position relative to the position of the focus• the pre-focal peak temporal-average intensity

• total entry power• temporal-maximum output power• ratio peak to average pressure• entry effective intensity• the peak rarefactional acoustic pressure

Page 28: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Calibration acoustic output power

BalanceBalance

Absorber

Power: P = m⋅ g⋅ c(T)

Radiation conductanceG = ∆Pavg / Ueff

2

28

Page 29: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Calibration acoustic output power at HITU levels

29

EU Joint Research Project:PTB, INRIM, UME, NPL

0,5-3 MHz5-150 Watt

Rel Exp. Uncertainty: 4,5-15,2%

Buoyancy method

NPL

Radiation ForcePTB

INRIM

UME

http://www.ptb.de/EURAMET-JRP7

See also contributions at ISTU from Haller, Jenderka, Shaw

Page 30: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Power measurements up to 20 WUncertainties can rise

• Gas / dust in the water (cavitation)

• Temperature increase, esp. at high power

• Air movement and vibrations

• Streaming effects

• Absorption in the water path

• Unwanted reflections of ultrasound

• Diverging beam

• Misalignment of ultrasound to target

• Reproducibility of the power to be measured

Up to

• 20%

• 2%

• 0,5%

• 2%

• 1%

• 5%

• > 25%

• 2%

• 2%

30

X

HITU

Page 31: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Set-up of the IEC 60601-2-62 standard (2)

31

- Accuracy of controls: Targeting accuracy

- Usability: Device type specific markingsOutput control Targeting accuracyUnintended output levels

- Hazardous situations and fault conditions (imaging equipment)- Electromagnetic compatibility

Page 32: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Device type specific markings to be displayed

32

(but not limited to) may be:

a) The expected temperature rise in the FOCUS during the treatment

b) The ENTRY POWER at the treatment setting

c) The ENTRY EFFECTIVE INTENSITY during the treatment

d) An indication in case cavitation occurs at the TARGET LOCATION

e) A display of the level of the reflected power

f) An indication of the THERMAL EQUIVALENT TIME

∫ °−='

0

)43)((43

tCtTk dtRt

Page 33: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Determination of temperature rise in tissue mimics

33

NPLAdam Shaw

ToshibaSatoshi Yamazaki

TNO

10 mm

80 mm

Puls-echo transducer

Therapy transducer26 mm

Region of interest

TNO

Lateral temp rise TMM 3 MHz

012

3456

78

-20 -10 0 10 20r (mm)

∆T

(deg

r. C

)

IR-measuredTheoreticalUS-measured

60 s heating; depth 11mm

Also:- MR systems- Modelling theories

Page 34: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Relevant information to be displayed

34

Targeting accuracy

An advice about the localization device to be used to localize the target shall be given.

The uncertainty of the positioning device to position the focus of the ultrasonic beam to the target location shall be given

Here the performance of the imaging equipment is important

Page 35: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Ultrasound Device Performance Standards (IEC)

35

IEC 61206 (TS)CW Doppler

IEC 61390 (TS)Performance Pulse Echo

IEC 62462 (TS)Maintenance

Physiotherapy

IEC 61391-1 Performance Pulse Echo

IEC 61689Performance Physiotherapy

IEC 61895 (TS)Performance

Pulsed Doppler

IEC 61391-2Performance Pulse Echo

IEC 61685Flow DopplerTest object

IEC 61266Hand held Doppler

IEC 61847Surgical Systems

IEC 61846Lithotripters

IEC 62649 (DTR)HITU

IEC 62558 (TS)Draft 3D Phantom

Page 36: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Ultrasound Device Performance Standards (IEC)

36

IEC 61390 (TS)Performance Pulse Echo

IEC 61391-1 Performance Pulse Echo

IEC 61391-2Performance Pulse Echo

IEC 62649 (DTR)HITU

IEC 62558 (TS)Draft 3D Phantom

IEC 60601-2-33Particular for MRI

Page 37: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Traceable measurements

are a must

Any value(Power, Pressure, Intensity,

Temperature, Image quantities)

Comparing (QA)With previous measurements

or colleagues

ConfirmationTo

Standards

Key comparisons(CIPM)

MetrologyPrimary standards

Proper uncertainty estimates

Effective trade between Nations

(MRA)

Traceability

37

Page 38: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Measurement facilities with a lack of traceability?? Medical UltrasonicsMedical Ultrasonics

• Ultrasonic Output Measurements

• Calibration Acoustic Output Power

• Calibration of hydrophones

• Measurement of high power

• Measurement of temperature

• Measurement of high pressures

• Measurements without synchronisation

• Measurement of air coupled Tx

• Performance test objects (sensitivity & dimensions)

• Increasing market in home care and cosmetics

38

Page 39: HITU - Standardization - · PDF fileHITU - Standardization - Metrology: WHY - WHAT ISTU, New York, 2011-04-12 Essential Performance requirements lists sources of unacceptable risk

ISTU, New York, 2011-04-12HITU - Standardization - Metrology: WHY - WHAT

Measurement of Medical UltrasoundMedical Ultrasound

39


Recommended