Routine Testing for Class I Medical Device


Hunkered Down for the Duration
Staff member
IEC 62354 is a copyrighted document and as such can not be "shared" or linked to here in the forum so it is best not to ask.

Thank you for understanding.
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Starting to get Involved
I hope it is OK adding a question to this topic instead of opening a new one on the very same subject.

I have the same problem as some users in this topic, how testing my Class I device in production. I have purchased IEC TR 62354:2014 because of ANNEX K, expecting it would give some directions on how production tests could be made in a way that could not be challenged by certification bodies. I was specifically aiming at the dielectric strength test voltages: I expected to have some bases to either reducing the test voltages or the time they are applied to the DUT (5s instead of 60s), as suggested on above posts. It turns out the ANNEX gave me no useful information at all. It is VERY vague and confusing (to me at least).

Where those 5s come from? Pure common sense or there is some rationale behind them that could be used as a rationale for testing.

The note of clause 5.1 of IEC 60601-1 (3.1) mentions either ANNEX K of 62354 or IEC 62353. But the latter does not prescribe dielectric strength tests. So once again we would be subject to the interpretation of the certification body.

Thank you in advance for your inputs.

Peter Selvey

Staff member
Dielectric strength is actually an ageing test for solid insulation, hence in theory it should not be done in production as it will age the insulation. It is also a white box test in the sense that it should be applied to individual parts such as wiring, transformers, opto-couplers, Y1/Y2 capacitors, connectors rather than the whole assembled equipment. Application to the assembled equipment risks stressing functional parts unnecessarily and there is no guarantee that the real insulation actually gets stressed.

This is an open and shut case, any agency that insists on blindly following the values in the standard for production tests on an assembled device should be and can be held accountable. It's almost certain that if you challenge it formally (with an explanation) the agency will back down. The problem tends to be the front line auditors that may not have the background/experience. This is something that I was taught when I started electrical safety testing back in 1987 but the theory seems to have fallen by the way at some stage.

A high voltage test can be a useful tool in production to detect assembly errors or other major mistakes. In this case though it is not an ageing test so the 60s is irrelevant. It just needs to be long enough to raise the voltage reliably. A value of 1-5s should be enough depending on the tester. It also needs to be first established that the application of the voltage will not damage any parts. Generally only some insulation paths can be tested this way, such as between mains and earth. Other paths and in particular 2 MOP paths are generally not practical.

If a manufacturer does use a test in production, the sample used for type tests should have undergone the same testing before any of the 60s type tests are applied. For example, if the planned production test is 60s, then the sample using in tested needs to be tested for a total of 120s.


Starting to get Involved
Hello, Peter, thank you very much for your comment.

I agree with your comment above on the high voltage test being a useful tool to detect assembly errors.

I have done a fairly extensive search in the Internet and nearly every guide/article I found (from manufacturers of test equipment) only makes reference to the 60s tests, with only one exception, a guide by SCI ("Ultimate guide to electrical safety testing").

Anyway, after searching and reading, the context these readings provided made Annex K of IEC TR 62354:2014 making sense to me. It turns out the Annex does provide instructions and requirements for test durations of 1 second and 60 seconds on paragraph K.1 e).

Now I have a question regarding the 1 s test duration part of K.1 e). The text says:
1) If the test duration is 1s, the ouput is to be maintained within the specified range:
- when only a voltmeter having an input impedance of at least 2MOhms and a specimen of the product being tested are connected to the output terminals AND

-when a relatively high resistance is connected in parallel with the voltmeter and the product being tested, and the value of the resistance is gradually reduced to the point where an indication of unacceptable performance just occurs.
I am trying to make sense of the second dash above. I mean, what that resistance connected in parallel is for? And what one is trying to achieve by "reducing it gradually to the point were an indication unacceptable performance just occurs"? It looks like a sanity check (like the 120kOhms resistance used elsewhere to verify the tester is working properly), but the paragraph mentions the product being tested, suggesting it must be connected along the check; if the test needs to be repeated reducing the resistance gradually, what would be the point? What am I missing?

Thanks in advance for any input.

Peter Selvey

Staff member
Unfortunately that standard costs US$380 and so far I haven't had the justification to purchase it. I'd love to go through it as TR and Guides tend to be poorly prepared because they can hide behind the "just a guide" disclaimer more so than normative standard.

Can I ask, does the 1s test require an increased voltage? In other words, they give the option of 60s at the normal voltage or 1s for an increased voltage? If yes, then this still goes against the principles of dielectric strength testing since it is still ageing the insulation, which needs to be taken into account in the type test (whatever is done in production needs to be also done in advance of any type tests).

As text shown, yes, this looks like a validation check for the tester to make sure it can deliver the current/voltage. In a type test, it's required to have a larger tester with 100mA capacity, but in production this would be overkill and is more dangerous. Lower capacity devices could be OK as long as it can be shown to reach the required voltage reliably. This looks like just a validation, i.e. before set up, at least once a year or at most once a day.

My preference is to use ac and record the current as a double check. This again gives a good indication if anything is amiss for either the test set up or the equipment under test, and would reduce the need to frequently check the tester.


Starting to get Involved
Hello, Peter.

Yeah, a lot of $ for just an ANNEX worth of information. :)

Answering your first question, no it does not require an increased voltage. Actually it does not state a voltage at all. The only thing it stipulates, right above the text I quoted, is the voltage value must not be lower than the "test value specified" (whatever it means) and not greater than 120% that value, regardless of the test duration.

As the Annex does not explicity state the voltage that must be used - paragraph a) just says "the stated a.c. value" - I think we could simply define whatever voltage we deem as adequate, but using the type test voltage values of the equivalent test points makes more sense to me and should require less explanation to the certification body. Simply beeing able to justify a shorter duration (1s) based on a standard (or TR in this case, referred by the main standard) is good.

Regarding the instrument, the requirements of the Annex are fairly easy to achieve with a good quality hipot and no specific current is specified so units that detect and break with a few mA must do fine. There are also some requirements about the output waveform being sinusoidal or boundaries if it is not perfecly sinusoidal, and also about the instrument being able to deliver a stable output voltage during the test.

Thanks for your comment on confirming my understanding on that dash paragraph.


We are Class I medical device company with all our products being DC powered LVDS and none of the products have essential performance.
1.Do we need to re-test emissions and immunity tests and have a new test plan, if we want to transition from Edition 2nd- Edition 4th?
2.Currently we are complying to 2nd Edition and after performing gap analysis I've figured out that there is no change in emissions limits. Would we still need to re-test and have a new test plan in order to comply to 4th edition ? In case of audits can we show the 2nd edition and gap analysis report ?

Mark Meer

Trusted Information Resource
...In case of audits can we show the 2nd edition and gap analysis report ?...
I'm not familiar with the 2nd edition of IEC 60601-1-2, but assuming you are correct that there are no changes to emission testing/requirements between the 2nd and 4th editions, then a gap analysis documenting this assessment will suffice as evidence of compliance to 4th edition requirements with respect to emissions.

That said, there are definitely several changes to the immunity requirements between the 2nd & 4th editions, so any gap analysis you document will presumably identify several gaps. will have to fill these gaps (or document appropriate justification not to).
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