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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson1
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Electrical Safety Testing of
Active Medical Devices –
New challenges. IEC 60601-1:2005
Presented by Norman Richardson
Senior Medical Device Specialist
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson2
IEC 60601-1:2005 The 3rd Edition
1. 60601-1:2005. Background and what went into it
2. 60601-1:2005. The major changes
3. Update on the collaterals
4. The technical challenges
5. The timing and implementation challenges
6. The cost challenges
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1:2005 The 3rd Edition
IEC 60601-1:2005
3rd Edition
„The General Safety Document‟
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson4
Background
1. 60601-1:2005. Background and what went into it
2. 60601-1:2005. The major changes
3. Update on the collaterals
4. The technical challenges
5. The timing and implementation challenges
6. The cost challenges
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
Background.
1st Edition 1977. Formed from an amalgamation of national
requirements but mainly from the UK and Germany (HTM8 and
VDE 0750). This was a ground-breaking document for which
the main UK participant was awarded an OBE. This edition
lasted until 1988.
2nd Edition 1988. More in-depth with greater emphasis on
creepage and clearance distances and insulation tests. With the
later Amendments 1 and 2, this document is still valid and will
continue to be so until June 2012. 128 pages plus 40 pages of
guidance and rationale.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
Background.
3rd Edition 2005. Massive document of 200 pages PLUS 180
pages of guidance and rationale.
Met with horror and disbelief at first.
Much opposition to it becoming a harmonised standard but it
was harmonised anyway.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
What went into the 3rd Edition?
• The contents of the 1st Edition and the 2nd Ed + Amdts 1 & 2
• Some alarm requirements from other mainly medical stds
• WG 14 Recommendations 1 to 56
• Large parts of IEC 60950 (IT equipment)
• Requirements for Expected Service Life (a „one-liner‟ with big
implications)
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
What went into the 3rd Edition? (contd)
• UL national deviations
• 60601-1 Medical Systems
• 60601-1-4 PEMS
• Risk Management requirements
• Essential Performance (in concept but see Particular Stds)
• Mechanical safety requirements from a variety of sources
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson9
IEC 60601-1 3rd Edition
1. 60601-1:2005. Background and what went into it
2. 60601-1:2005. The major changes
3. Update on the collaterals
4. The technical challenges
5. The timing and implementation challenges
6. The cost challenges
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
• New clause numbering. (Now 17 clauses instead of 59)
• Clause 4. New Single Fault Conditions. New major
requirement for a Risk Management (RM) file to ISO 14971.
There are over a hundred references to the RM file in the
standard and manufacturers must ensure that the questions
posed are answered in the RM file. Therefore in reality there
must be an RM file tailored to the GSD.(example: 8.6.3 PE of moving parts. Requirement, blah blah blah. Compliance is checked
by.........inspection of the RM file)
• Essential Performance. The risk must be assessed of the
loss of the primary intention of the equipment or critical
aspects of its performance.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
Examples of Essential Performance
Essential performance - a high speed tutorial
Each item of equipment has a primary intention, a ventilator
must ventilate, a defibrillator must defibrillate and an X-ray
system must produce an image. This is their Essential
Performance
In addition, in any specific application, one or some of the pure
performance aspects of a product may be critical to the safe and
effective operation of the equipment. They are not nice-to-have
features, they are ESSENTIAL.
For many attributes which in general are probably pure
performance, one can think of an item of equipment for which
the attribute is critical, examples:11
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
Examples of Essential Performance
...and so on
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‘Pure’ safety But critical in.......
Fast operation Interventional MRI
Quiet Baby incubator, audiometer
High definition Ophthalmological ultrasound
Comfortable patient support Conscious neurosurgery, dentistry
Quick set-up Emergency ventilator, stretcher
Nice display colours Doppler colour flowmetry
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
Essential performance - examples
Some more general examples of essential performance (but still
somewhat equipment specific):
• Does not switch to full output power
• Does deliver correct output
• Makes a correct diagnosis (or a very detailed diagnosis but
not an underdiagnosis)
• Does not overpump
• Has adequate bandwidth to show abnormalities
• Questions unusual operations
• Operates smoothly (hoists, treadmills, ergometers)
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
New requirements on a clause by clause basis
• Clause 5. General Requirements for testing..... and Clause
6. Classification
No significant changes
• Clause 7. Identification, marking and documents. No
significant changes, but see EN 980:2008 and new
requirement in MDD to have IfUs as controlled docs.
• Clause 8. Protection against electrical hazards.
This is where substantial new material appears.
8.2.1 Connection to a separate power source clarified
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
New requirements on a clause by clause basis
8.5 New concepts of MOP, MOOP and MOPP with Means of
Patient Protection (MOPP) being more rigorous than Means
of Operator Protection (MOOP). MOOP comes from 60950.
There are detailed and complex tables for determining test
voltages and C&C distances.
(These replace A-a1/k and B-a/e which have GONE)
8.7.1 and 8.7.3. Touch Current rather than Enc Leakage
Current, Earth Leakage currents of 5mA (NC) or 10mA
(SFC). 10x earlier values now allowed BUT it can flow only
down the Earth wire and must NOT be available on the
enclosure. This enables the possible use of more
„commercial‟ power supplies. ELC now taken out of leakage
current table (Table 3 page 86) 15
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
New requirements on a clause by clause basis
8.7.4.7 h) New leakage current concept for multiple APs of
same type connected together (total Patient Leakage
current).
8.9 C&C MOPPs based on earlier editions and MOOPs
based on 60950 (less stringent). Complex tables need to be
studied for the applicable values in any particular case.
Added concepts: Altitude of operation needs to be taken into
account. Additional insulation classifications (CTI, I, II, IIIa &
IIIb). Overvoltage categories extended („cleanliness‟ of
supply). Degrees of pollution extended (reminiscent of
61010). Insulating compound taken into consideration
(„potting‟ and encapsulation)16
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
New requirements on a clause by clause basis
• Clause 9. Mechanical hazards
The hugely expanded requirements can broadly be
considered in two categories.
Damage to the patient or user by movement of the
equipment. Hazards such as crushing (all body parts
mentioned plus the clearances which need to be allowed),
cutting, entanglement, stabbing, abrasion, falling and so on.
Instability and damage due to pressure are included.
Damage to the patient or user by failure of a suspension or
support means. Required safety factors of such means are
given.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
New requirements on a clause by clause basis
• Clause 10. Unwanted or excessive radiation.
Generally the same as before. Reliance is placed on the
manufacturer‟s RM file.
• Clause 11. Excessive temperatures.
Significant changes in the direction of more relaxed
requirements (ie higher temperatures permissible) BUT any
temp in excess of 41 C (the traditional value) must be
justified, is material dependent and must feature in the RM
file.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
New requirements on a clause by clause basis
• Clause 13. Hazardous situations and fault conditions
Many new examples of SFCs. Motor locking, cooling failure,
detachment of wires and connectors, blocking of filters and
so on (see also Part 2s). Heavy dependence on RM file.
• Clause 14 PEMS. This former collateral (60601-1-4) now
incorporated into the GSD.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
IEC 60601-1 3rd Edition
New requirements on a clause by clause basis
• Clause 15. Construction.
Where access for servicing is needed, it shall be provided.
Numerous requirements for the strength of the equipment
against dropping, pushing, impacting and rough handling.
• Clause 16. Systems. The former collateral standard 60601-
1-1 is now incorporated into the GSD. Multiple socket outlets
now allowed.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson21
The collaterals
1. 60601-1:2005. Background and what went into it
2. 60601-1:2005. The major changes
3. Update on the collaterals
4. The technical challenges
5. The timing and implementation challenges
6. The cost challenges
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The collaterals
Collateral standards
• 60601-1-1 Systems. Now part of the main standard.
• EMC 60601-1-2:2007, generally as before but the
requirements can be modified by the mfr‟s RM file.
• 60601-1-3:2008 Radiation protection in diag X-ray equipment
• 60601-1-4: PEMS. Now incorporated into the main standard.
• 60601-1-6:2007 Usability. Not a pass/fail standard but a
design guideline. This is an assessment of the ergonomics of
the design. The manufacturer is expected to be able to show
that „Usability‟ factors have been considered in design. For
post design appraisal, TÜV is able to have the equipment
assessed by a panel of expert and lay users and prepare a
report on the Usability.)
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The collaterals
Collateral standards
• 60601-1-8:2006 Alarm systems (frequently overwritten by the
particular standard)
• 60601-1-9:2007 Requirements for environmentally conscious
design
• 60601-1-10:2007 Development of physiologic closed loop
controllers
• 60601-1-11: Home health care (in development, FDIS Feb
2010)
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson24
The technical challenges
1. 60601-1:2005. Background and what went into it
2. 60601-1:2005. The major changes
3. Update on the collaterals
4. The technical challenges
5. The timing and implementation challenges
6. The cost challenges
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The technical challenges
Designers, manufacturers and test houses have put off any
involvement with the 3rdEdition as long as possible. There was
hope that the standard would not be harmonised but it was.
Another reason is that (TÜV has found) the testing time and the
testing costs are about 70% greater than the 2nd Edition.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The technical challenges
Apart from the increase in the number of tests, the new
mechanical tests where applicable and the complexity of the
standard, there is also a RM file to assess and test parameters
to adjust in the light of the RM file.
A number of the superficially similar requirements have detail
changes and therefore do not map directly across from 2nd to
3rd Eds
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The technical challenges 2
Are there any advantages to the 3rd Ed?
In general, power supplies approved to 60950 can be used and
more substantial filters are allowed to help with EMC
compliance.
Battery circuits and charging arrangements have been clarified
In the test voltage tables, it is now acceptable to interpolate
between values.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The technical challenges 2
Are there any advantages to the 3rd Ed?
Mechanical safety covered.
Detailed and explicit Guidance and Rationale (in line with recent
IEC standards policy)
Note: Parts of previous versions of 60601-1 have been
inappropriately used for routine production testing and testing
following servicing or repair. The 3rd Ed is even less suitable for
these applications.
Now covered by a specific standard, IEC 62353.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson29
Timing and implementation
1. 60601-1:2005. Background and what went into it
2. 60601-1:2005. The major changes
3. Update on the collaterals
4. The technical challenges
5. The timing and implementation challenges
6. The cost challenges
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
Timing and implementation
Among many other things, the clause numbering in the 3rd Ed is
different.
Therefore a Part 2 standard intended to relate to the 2nd Ed
cannot be used with the 3rd Ed.
Testing of products for which there is a Part 2 must be done to
the 2nd Ed until a “3rd Ed” Part 2 becomes available. Only
about half a dozen 3rd Ed Part 2s are available out of about 40
Part 2s.
Transition time will depend on the availability of Part 2s. In
general the 2nd Ed will stay valid until June 2012 (June 2013 in
the USA). If a particular Part 2 standard is still not available by
June 2012, the 2nd Ed will remain valid for longer.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson31
The cost challenges
1. 60601-1:2005. Background and what went into it
2. 60601-1:2005. The major changes
3. Update on the collaterals
4. The technical challenges
5. The timing and implementation challenges
6. The cost challenges
TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The cost challenges
3rd Ed testing is about 70% more expensive than 2nd Ed.
What do manufacturers do if their product has been successfully
tested to the 2nd Ed? TÜV offers „delta‟ testing.
That is, not testing the 2nd Ed aspects which have already been
done but only testing the 3rd Ed additions.
This keeps costs down a bit and shortens the testing time a bit
but this is not entirely straightforward.
Why? Because many of the apparently similar requirements
have detail changes and therefore do not map across from 2nd
to 3rd Eds. Nevertheless it does save testing time as TÜV has
carried out a very careful clause by clause equivalence
appraisal.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson
The cost challenges
What else can our clients do to keep costs down?
Prepare an insulation diagram so we don‟t need to do it at
increased cost. Use certified major components. Provide all the
supporting documentation and certification required. Provide
test reports of earlier tests (the previous model) if applicable.
Do prepare a relevant Risk Management file. TÜV can provide
you with a checklist for the elements you need for the 3rd Ed.
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TÜV Product Service Ltd © 60601-1 3rd Edition Norman Richardson35
TÜV Product Service LtdOctagon House
Concorde Way Email: [email protected]
Segensworth North Tel: +44 (0) 1489 558 217
Fareham, Hampshire Fax: +44 (0) 1489 570 686
PO15 5RL, UK Website: www.tuvps.co.uk
Thank
You
http://www.tuvps.co.uk/
Norman Richardson – Medical & Health Services