TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Webinar Application of IEC 60601-1:2005Part 1: General requirements for basic safety
and essential performance
Speaker Alberto Paduanelli
Medical Devices Lead Auditor MHS-UK
Tel: +44 (0)1489 558219
[email protected] www.tuvps.co.uk
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 2
General Information:
• Time of presentation: 45-50 min.
• Question & answer time at the end: 10 min.
• You will get this whole presentation as pdf-file after the
webinar via email.
• Some pages will not be commented, marked with:
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 3
CONTENT - Modules:
General information about the 3rd Edition
Transition period of the 3rd Edition
News related to mechanical safety testing
New concept, changes and effects for manufacturers
Next steps for implementation
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 4
Module 1
General information
about the 3rd Edition
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
WHAT IS THE 3rd EDITION ?
51-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 6
Consequences:
Too many changes in the most important general basic standard in
one single step (2Ed 3Ed) have created the following problems:
- Some markets & their authorities have not (yet) accepted
the 3rd Edition (e.g. USA: OSHA, China: SFDA).
- Mistakes in the standard.
- Gaps in the standard.
- Unclear requirements in the standard.
Addition:
- New structure e.g. clause 15.b residual
voltage at the plug has become clause 8.4.3.
- The 3rd Edition was written by different working
groups.
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 7
Solutions:
Worldwide different parties are working on solutions, e.g.:
- A1PMT and their WG's and MT's Amendment 1.
- IECEE-RM-TF RM & TRF in the CB scheme.
- National committees e.g. DKE, replacing RM links by clear
Pass/Fail requirements.
- Corrigendum
- ......
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 8
CDV: IEC A1
March 2011 June 2012
Around 200
change requests
have been
discussed.
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 9
Module 2
Transition period
of the 3rd Edition
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
EUROPE
• Law basis is the directive MDD 93/42/EEC.
• Annex I contains the Essential Requirements (ER).
• Objective evidence of compliance with the ER is demonstrated by:
A) Harmonized standards (> 99% used):
The reason, why usually harmonized standards are taken, is their
presumption of conformity with the ER less discussions!!
B) Other sources (< 1%, used only in exceptional cases, and even
then only for a few single clauses of a harmonized standard):
Deviations from harmonized standards must be justified &
documented create questions!!
101-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 111-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 12
159 pages: TRF
- 104 pages: requirements,
- 55 pages: tables for results
104 pages x 13,6 requirements
per page = ca. 1422!
How many
requirements are we
talking about?
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 13
Requirements:
- The 3rd Edition contains exactly 1422 single requirements, each has
to be verdict by PASS // FAIL or N/A.
- Thereof are 729 requirements identical or even less stringent as in
the 2nd Edition. Measuring results & verdicts of 2nd Edition can be
transferred to the 3rd Edition TRF.
- However there are 693 requirements in the 3rd Edition totally NEW
or MORE STRINGENT than in the 2nd Edition. That is ca. 50%!!!
new measurements and/or new verdicts and their documentation are
required.
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
2Ed TRF
+
+
RM
Vigil-
ance
system
≠
141-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Based on:
- 3 times longer blank TRF
- 693 new or more stringent requirements
- no available delta-TRF (per IECEE resolution a delta-TRF will not
be created by IECEE!)
- Differences 2Ed vs 3Ed are in the detail (read the wording of the
standard EXACTLY!)
- 2Ed testing was often conducted several years ago and
changes on the product (under Annex II) are not documented in the
original TRF !!
- World markets require a complete 3rd Edition TRF,
The documented objective evidence of 3Ed compliance
should be demonstrated by using the new TRF 3Ed (Version „g“
from Dec. 2010), so far applicable by using raw data of 2Ed
(measurements, verdicts).
151-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
The ZLG-paper 3.5 A1 makes it extremely clear:
„The missing new assessment by the manufacturer after the end
of the „doc“ or the missing knowledge about the existence of new
harmonized standards or scientific knowhow are substantial NON-
conformities. If these NON-conformities will not be adequately
corrected, the certificates have to be suspended or withdrawn.“
(Production stop!)
The „new assessment“ requires a documented point-by-point
assessment of all standard changes.
Objective evidence: Use new TRF version „g“ (or provide
documented statements & measurements to the 693 changes
which are not covered by 2Ed).
161-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 171-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 181-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 19
How much time do we
have? 182 days
(at 30 November 2011).
You cannot afford to loose
ONE SINGLE FURTHER DAY!
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 201-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 21
Module 3
News related to mechanical
safety testing
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Why are there so many problems with the 3rd Edition, e.g. in the
chapters of mechanical safety and electrical safety?
A validation of the standard (= testing of a few different MEE„s)
has not been conducted prior to the publication of the standard.
221-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Example threshold test:
23
Source: TÜV SÜD Lab
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 24
2ED clause 21.6.b
20 mm down
2ED
3ED clause 9.4.2.4.3
20 mm up and down
3ED
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Planned A1 solution:
3 parameters have been changed simultaneously:
Threshold 20 mm 10 mm,
Threshold gets a radius of 2 mm at the edge,
Speed 0,4 m/s 0,8 m/s.
If those changes will not lead to a PASS Method how the MEE
could come over the threshold needs to be described in the IFU
(e.g.: wedges // pulling // 4 person carrying // …..).
251-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 26
Module 4
New concept, changes and effects
for manufacturers
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
20 errors
which should be avoided when
applying IEC 60601-1:2005
271-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„The 3rd Edition contains only easier requirements
than the 2nd Edition.“
ANSWER:
By EXACTLY comparing the wording
of both editions,
693 totally new or more stringent requirements exist.
…in case of any later law issue a judge wants it as well
knowing EXACTLY. Then verdicts like „similar“ are not
accepted!
NOTE: The verdict „similar“ does not exist in testing field!
281-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„If my product does not comply with any requirement
(clause x.y) of the 3rd Edition,
then risk management
(PROBABILITY X SEVERITY) shall be
conducted, this will settle the case.“
ANSWER:
See next pages.
291-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 301-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
There are 1422 single requirements in the standard.
Group A:
Only 153 thereof have a direct link to RM (key-words are: RMF,
unacceptable risk, etc.). Here RM is allowed!
Group B:
All the other 1269 requirements have to be handled as in 2nd Edition.
That means concrete, that RM alone is not enough to get a PASS if a
specific clause is violated. The standard requires here to choose
the way via objective evidence of „equivalent safety, clause 4.5“.
Here the residual risk of the new risk control method must be at
least equivalent to the method prescribed in the specific standard
clause concerned. Comparing residual risks is required!
311-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„Instead of the evaluation of the RM-File, it is also
allowed to conduct a process audit
according to ISO 14971.
A positive audit result leads
automatically to a PASS of all
clauses in the 3rd Edition which
refer to RM.“
ANSWER:
See next pages.
321-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 33
The standard clause 4.2 says:
“Compliance is checked by inspection of the RM-FILE.“
It is not allowed to replace the standard wording as follows:- Inspection Audit and- FILE PROCESS.
Auditing always means sampling. Testing means each standard clause (100%) will be verified – no sampling approach.
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„If the MANUFACTURER will come to a result in his RM,
then this result can NOT be questioned
by other institutes like
test houses & authorities.
The standard confirms this
explicitly in clause 4.2.
Therefore the role of certifiers has changed
Changed standard philosophy =
ANSWER:
See next pages.
341-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 35
It is written in the standard clause 4.2:
“The policy for determining acceptable RISK*** and the
acceptability of the RESIDUAL RISK(S) shall be established by the
MANUFACTURER.” Solely the MANUFACTURER!!
“Compliance is checked by inspection of the RISK MANAGEMENT
FILE. The requirements of this clause and all requirements of this
standard referring to inspection of the RISK MANAGEMENT FILE are
considered to be satisfied if the MANUFACTURER has:
– established a RISK MANAGEMENT PROCESS;
– established acceptable levels of RISK; and
– demonstrated that the RESIDUAL RISK(S) is acceptable (in
accordance with the policy for determining acceptable RISK ***).“
The standard does not speak about evaluation conducted by third
party certifiers, like CB-labs, NRTL-labs, Notified Bodies, others.
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 36
What does “inspection” mean?:
It means that it is enough if
certifiers check that:
a) The RMF is available.
b) The RMF is complete.
It does NOT mean that certifiers
are authorized to evaluate the
correctness of the RMF.
Can certifiers agree to that?
RMF
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 37
What does the MDD require?
For example within Annex III EC Type examination the MDD 93/42/EEC requires in clause 4.1:
“The Notified Body must examine and assess the documentation and verify that the type has been manufactured in conformity with that documentation.”
Other annexes like Annex II require examination and assessment as well (Annex II, clause 4.1 – 4.3).
The MDD requires more than just “inspection”, it requires “examination and assessment”!!
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 38
What does the IECEE / CB-scheme require?
The IECEE RM training in Milan in April 2009 was organized for
all CBTL‟s and NCB‟s and IECEE assessors in the category MED
to clarify questions related to RM in the IEC 60601-1 (3Ed.).
Lecture 7 “Risk Management Responsibilities, Responsibility of
the Manufacturer and the CBTL” page 14 answers the question
very clearly:
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 39
RESULT
a) 60601-1 does NOT require RMF-evaluation by certifiers.
(at least if we ignore the “state of the art” clause 3.3 of 14971
which refers to international standards and regulations).
b) MDD & IECEE say: RMF-evaluation by certifiers is a MUST.
Both statements are in conflict with each other!
What to do?
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 40
The law has a higher level of binding (legal) character
than a standard and therefore overrules the standard.
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 41
NON RMF-evaluation
by certifiers:
2-eyes-principle-only
= not allowed for MDD
and CB approval
RMF-evaluation
by certifiers:
4-eyes-principle
= state of the art
I) Designing by manufacturer (2-eyes principle)
II) Test & Review by an independent third party (add-on 2-eyes!)
The „state of the art“ is the so called 4-eyes-principle, which means
that approval systems conduct RMF-evaluation.
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
If you drive too fast according the law …
“Your speed was too high!”
Sorry Sir (CBTL, NB, NRTL), you are not authorized to evaluate my speed (i.e. my RMF), I have a driver license according the 3rd Edition, here it is!
421-Dec-11
Is this how the approval systems should work?
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 43
Example: Electric shock
# Cause, Function, Effect
Hazard P (B) S (B) RISK (Before) = Initial Risk
1 240 VAC mains voltage accessible, effect on operator
Electric shock
5 5 25
RISK Control
Verify Impleme-ntation
Verify Effective-ness
P
(A) S
(A) RISK (After) = Residual Risk
Report (Objective Evidence)
- Warning label, - manual warnings
1 5 5 Report XYZ
Using descriptive safety instead of an enclosure
is violating the state of the art. This example shows
that evaluation of the RMF by an independent
organization cannot be omitted!
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 44
Conclusion:
Evaluating the RMF is required for:
- MDD (CE commission)
- CB-scheme (IECEE).
From FDA, OSHA, SFDA, etc. no written statements
are available at the moment (30th Nov 2011).
However, it is not expected that any authority will
skip “evaluation”.
The 3rd Edition does NOT change the role of
Notified Bodies, because they are bound to EU law
more than to a standard !
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„If the standard will be applied LITERALLY then the result
is always on the safe side.”
ANSWER:
See next pages.
451-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Clause 9.4.2.3
• LITERAL application
of the 3rd Edition would
introduce new hazards:
tripping hazards!
461-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Clause 9.4.2.3
47
Source: DKE paper 811.1_2011-0001 dated 3. Jan. 2011
1-Dec-11
LITERAL application
of the 3rd Edition would
introduce new hazards:
tripping hazards!
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„The limit for Earthleakage current
has been increased by the factor 10
which is easier to comply.
2Ed: 0,5 mA NC and 1,0 mA SFC
3Ed: 5 mA NC and 10 mA SFC.
ANSWER:
The new introduced Touchcurrent (0,1 mA NC // 0,5 mA SFC) will
be measured at MEE's at PE connected enclosure parts. Therefore
the limits in SFC (= PE open) are identical to the 2nd Edition of the
earth leakage current.
481-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„For the operator protection (MOOP) it is allowed to take
IEC 60950 approved power supplies, there are no further
requirements for these power supplies.
ANSWER:
- Earthleakage current in 60950 is higher than in 60601-1.
- MD in 60950 is different to the MD in 60601-1.
- 60950 requires only 1 fuse in the power supply of a class I device,
whereas 60601-1 requires 2 fuses.
- The barrier „opposite polarity“ is missing in 60950.
- Test criteria in 60950 have to comply with final use criteria of the
MEE in 60601-1 (altitude, pollution degree, etc.).
491-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„I have not found a 3Ed approved Power Supply (PS)
on the market. Therefore I will keep the 2Ed CB approved
Power Supply in the MEE (without upgrade
testing to 3Ed), because what
was safe in the past,
will be safe in the future as well.
ANSWER:
Mixture-certification of 2Ed Power Supply used in 3Ed MEE is
forbidden. Therefore 2Ed approved PS needs to be upgrade tested
to 3Ed.
501-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
For “quasi” Applied Parts according clause 4.6 it is only
required to test the barrier based on MOPP
and the patient leakage current.
ANSWER:
In addition do not forget:
- Biocompatibility
- Temperature for AP's in NC and SFC!
511-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
Each IFU is using „Descriptive Safety“. If these safety
instructions will not be followed, a hazard could arise.
The corresponding safety sign is
allowed to be used in black-white and
may be placed at the rear side of
the MEE.
ANSWER:
Read the standard exactly:
- 7.2.3 Inspection of the IFU is a mandatory action.
- 7.6.2 Colour of standardized symbols must be used.
- 7.1.2 Clearly legible from the intended position of the
operator.
521-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
Within the CB-scheme collateral standards, such like
IEC 60601-1-4, IEC 60601-1-8, ….
can be excluded.
ANSWER:
See next page.
531-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 541-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
The normative part of clauses 8.5.2.1 and 8.5.5.1
contains requirements which lead
to defibrillation of the operator.
Is it allowed to market such a
literally “correct” product?
ANSWER:
Apply solution
out of A1.
551-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
A “defibrillated” operator can not be justified by RMP. Take solution out of A1-CDV 2011.
561-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
The insulation diagram can be completed
on paper basis only,
if the voltages inside of the circuits
are known.
ANSWER:
- The WORKING VOLTAGE
according 3.139 must be
additionally measured.
- Additional influences (see
next pages) need to be
considered.
57
MP240V ~
AP 12 V-1 4
2 3
5
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 58
Additional information:- Part 2 standard applicable?
- SIP/SOP restriction in IFU?
- AP: Protective impedance needs to be checked in NC+SFC.
- IEC 60950 approval/compliance? NOT allowed to PATIENT.
- No glass, mica, ...exist.
- Application < 2000 m altitude.
- Material group IIIb.
- Pollution degree 2.
- Overvoltage category MAINS: II.
- No peaks generated.
- Defiproofed AP?
- Quasi AP‟s?
- IC, AP earthed?
- Interpolation used?
1-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
I will wait with pilot projects
until ALL mistakes in 3Ed are solved.
ANSWER:
Then you will wait until the A2, approximately 2016.
Almost no manufacturer has the financial resources to survive a
production stop between 2012 – 2016.
591-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
„An upgrade testing 2Ed 3Ed
will take 2 weeks.“
ANSWER:
- For a simple battery powered MEE MAYBE,
however in this case everything must be right at the first time:
RM, collaterals, IFU, EP, design, etc.
- If a non-compliance report will be issued 4 weeks.
- If a redesign is necessary 2-3 month.
- For a complex MEE (e.g. MRI) including part 2 standards
longer!!
601-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
The testing time is usually underestimated:
TRF scroll down ….
- every single requirement of the 1422 TRF points has to be read
- understood
- maybe the corresponding Annex A has to be consulted
- the IFU has to be checked
- clarify questions with colleagues or the manufacturer
- check the RM-file
- conduct tests & document the tests
- fill out RM tables and make final verdict
- write a non-compliance report
- TRF review by a second authorized expert
If you have done that 1422 times for a single product, then
the part 2 standard(s) & collaterals are still missing ….
Whoever claims that a normal MEE is testable within 2 weeks
has no practical laboratory experience with the standard
= has never applied the standard at an MEE by own testing.
611-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
I found a 36-pages DELTA TRF in the
internet which compares 2Ed with 3Ed
only related to the headings.
Can I use this instead of the 159-pages IECEE version “g”?
ANSWER:
Chapters in the 3Ed contain several requirements.
A point-by-point comparison of each of the 1422 requirements
is needed.
An exclusive heading comparison is meaningless.
621-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
I would like to fix-book / reserve
an 8 week testing time
for next year February - March 2012.
ANSWER:
TÜV SÜD principle: FIRST IN = FIRST TEST.
When order (1) + documentation (2) + product (3) have been
COMPLETELY received by TÜV SÜD, we will define a testing
start date & an estimation of the testing time.
631-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
Because I am not able to keep the
transition period, would the following
solution be acceptable?
1. I will conduct under my Annex II MDD system an
„Alibi“ 3Ed testing. Possible errors will maximum be verdict
by the NB as „minor“ NC.
2. Due to the time, which I will win, I will later conduct
a CB 3Ed testing to correct errors of my first testing.
ANSWER:
All applicable requirements of the total 1422 requirements need
to be correctly implemented when the transition time is over.
641-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
I have heard that the 3Ed will be
de-harmonized.
Can I trust this information?
ANTWORT:
Up to now (30th Nov 2011) there is NOT ANY hint about
de-harmonization of the 3Ed.
651-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
ASSUMPTION:
If the manufacturer is not able to comply with 3Ed
at the End of the transition period, then
this is not critical because
all involved parties are searching for
solutions.
ANSWER:
There are certain risks if such MEE will be marketed:
- Competitors could inform authorities (recall, shutdown).
!! >>Example a few are prepared.….>>!!
- Authorities could be active stop to marketing such MEE.
- In case of a law issue, the judge is not interested in any
private opinion (Example NOTE in IEC standard…..).
661-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Module 5
Next steps
for implementation
671-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
Strategy for a fictive case:
► Date: November 2011
► 10 products on the market approved according 2Ed.
► All 10 TRF‟s of the 2Ed are brand new from 2010
(= no undocumented product changes) Unrealistic !
► Annex II MDD certified.
► Up to now, no practical experience with the 3Ed.
((… a little bit late to start …))
681-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
1. Read the standard
2. Buy IECEE TRF version „g“
3. Make a decision which products will be phase-out at the
end of the transition period, e.g. 2 old products.
691-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
4. Set free personal resources
(if you want to stay in the market after 2012)
QUALIFICATION and TRAINEE-TIMES for test engineers:
► Education: Engineer, Dr. (PhD), etc.
► Initial training, authorization, experience:
- Basic standard: 2 - 4 years
- Part 2 standard: 1 - 2 years per standard
- Specials like SW, PEMS, EP FUSA, RM: 2 years.
Don‟t use beginners for MEE product testing!
Increasing personal resources in 2011 is already
too late! (should have been conducted 2006).
701-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
5. Buy missing test equipment.
6. Study the OJ for the remaining products for which
part 2 standards allow a longer transition period
(2013, 2014, …).
7. Business analysis: Which products will get
priority „1“, based on market needs.
8. Start with the most important product.
711-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
9. One product should be tested by TÜV SÜD as a pilot
testing to gather experience. At the same time,
the same product will be tested under Annex II.
Compare the testing results point by point and discuss
them with TÜV SÜD.
10. The remaining 9 products will be tested according
Annex II.
721-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD
TAKE-HOME MESSAGE:
Transition period: The MEE testing of the 693 changes of the
standard should start 2011.
Safety: If there is a clear mistake in the 3rd Edition use
e.g. the solution out of A1. To find out if
something is a clear mistake, please ask.
Effects: - Conduct a carefully point-by-point analysis
for the real 3 Ed requirements for your MEE.
- Prepare documentation and samples.
- Start pilot projects ASAP.
START TODAY, DON„T WAIT ANOTHER DAY.
731-Dec-11
TÜV SÜD Product Service GmbH Copyright by TÜV SÜD 74
Contact details:
Alberto Paduanelli
Medical Devices Lead Auditor MHS-UK
TÜV SÜD Product Service LtdOctagon House, Concorde Way, Segensworth North, Fareham, Hampshire, PO15 5RL
Tel: +44 (0) 1489 558219Fax: +44 (0) 1489 558101Mobile: +44 (0) 7740 211139
Email: [email protected]: www.tuvps.co.uk
Thank You!
1-Dec-11
THANK YOU
Alberto Paduanelli Medical Devices Lead Auditor MHS-UKTel: +44 (0)1489 558219
www.tuvps.co.uk