No - not a missed opportunity but possibly mis-directed and possibly being used as a springboard to develop and sell a product which I totally disagree with if it is the case.
This aside it's a more prescriptive approach to testing and could be used to make the applicability of tests, for those technically less competent or less knowledgeable, less ambiguous than the current standards for routine purposes.
Thanks Barney for your kind comments on our seminar. I am pleased you found the information useful.
It was very interesting for me to receive many positive comments on the IEC 62353 yet the UK experts voted against the IEC 62353 draft.
I'm left wondering why the UK experts voted against 62353 if, as a standard for routine safety testing, it has significant benefits over and above the tests that are specified for 60601-1?
Geoff is right about the legal requirements only being driven by the HSE. How can you prove something is save if you do not test. I therefore believe more guidance would be beneficial on testing intervals (shortfall on the IEC 62353)
More guidance, i.e. a standard that's not mandatory, is not what's needed, it's more prescriptive routine testing legislation that is needed from the HSE, MHRA and DoH based on evidence plus a standard for routine testing that's acceptable to UK experts.
However, as mentioned in the seminar, the IEC 62353 is published and will further develop over the years (just like the IEC 601 has done over 30 years) to grow to a better document perhaps suitable for making it mandatory (it will be mandatory in Germany next year). This would make matters clear and will get rid of the pat testing "biomed" engineers like you have mentioned in this forum.
As is clear from this forum, the IEC 62353 will provide a more efficient and saver working practice across the UK for those who currently test to IEC 60601 (or pick and mix see previous forums)
IEC 62353 appears to follow identical tests to 60601-1 except that it specifies IR testing (which, as it happens, is performed on most if not all of the automated/semi-automated "pick and mix" "60601-1 compliant" electrical safety testers that I've ever used).
IEC 62353 specifies the MINIMUM earth bond test current of 200mA - higher test currents can be used.
An important factor is that IEC 62353 does not include the single-fault tests that ensure medical devices are capable of remaining electrically safe under SFC.
IEC62353 also applies limits from earlier revisions of 60601-1 that may no longer be consistent with the 3rd edition 60601-1 standard.
On balance IEC62353, as it stands, may potentially add to confusion and does not necessarily make safety tests (that are generally perfomed using automated/semi-automated safety testers) easier, safer or significantly faster. Not for Engineers that apply the tests after re-manufacture of systems, during evaluation or acceptance checks, anyhow.
My view is that IEC62353 may not be suitable for anything but routine test purposes hence I'd be inclined to continue testing using a "60601-1 compliant" with IR tests and earth-bond test current that is capable of overcoming poor contact resistance and surface contamination, for accetance, evaluation, re-manufacture and after repairs.
Accepting the fact that we cannot possibly perform testing to all of the requirements in the 60601-1 standard, since some are destructive - that's not what we try to achieve with safety testing in the field and this has been the case for years since BS5724 was published in the 70s.
For those who missed the seminars or would like to receive a copy of the presentation, drop me an email (email@example.com)
We aim to continue with further seminars in the near future. Any suggestions on locations across UK and Ireland or even abroad?
As well as the Rigel 288 if you want a safety tester that can be used as a versatile bench instrument for Engineers used in evaluation, acceptance-checks and tests after re-manufacture of stuff like video endoscopy stacks, etc, then I'd suggest the highly portable (mains operated) Gossen Metrawatt Secutest SIII
This includes IEC62353 (VDE0751) and a host of other standards/limits for British/European Standards IT/ Telecoms, Laboratory, PAT, Household, etc. Internal printer, 4-wire kelvin Ohms measurement, in fact some nice "instrumentation" features with some useful accessories.
It doesn't include any "gimmicks" plus, to be fair and balanced, I'd say that its database connectivity/data storage and retrieval is not really setup for high volume tests, like the QA90 or Rigel 288, for throughput, and it's not quite as configurable when it comes down to mixing applied parts (unless this has now been addressed in later software) but it is a decent bench instrument for engineers (Voltmeter, Ohmmeter, Ammeter, Power-Factor, Functional tests, etc).
Very competitively priced with a 25A, 10A/200mA earth bond tests and, more importantly, specified tolerances and errors that are more meaningful than many of the technical specifications and performance metrics that're given by the competition. Perhaps this is because it's manufactured for the German market and has to comply with legislation.
Although the high current pulse followed by 200mA earth bond test of the Rigel 288 is novel it only has single wire, i.e. Ohms needs to be zeroed, earth bond resistance measurement, plus the accuracy of measurement appears to be outside those generally specified in IEC62353 due to a combination of display resolution and basic accuracy, for example.
I'm of the opinion that NO electrical saftey tester, including the Rigel 288, can avoid presenting potentially injurous voltages or currents to the operator or even the equipment under test. That's in the nature of electrical safety testing unfortunately.
I wouldn't be surprised if there are disclaimers and warnings about the potential for damaging or injurous voltages and currents during testing in the operator manual - just like all the other EST manuals.