IEC 60601-1 clause 8.8.3 - Dielectric Strength

#1
Hi all,

The standard says:

Compliance is checked by applying the test voltage specified in Table 6 for 1 min:

Initially, not more than half the test voltage is applied, and then it is gradually raised over a period of 10 s to the full value, which is maintained for 1 min, after which it is gradually lowered over a period of 10 s to less than half the full value

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Table 6 - Test voltages for solid insulation forming a PROTECTIVE MEANS

In a production line, all equipment must undergo this routine test, correct?

My doubt, would I have to strictly follow the 10s ramp-up of the voltage, then 1min in the voltage value according to table 6, and after 10s of the ramp-down of the voltage?

Or a reduction in these times can be made because we know that solid insulation can be destroyed, right?

Are there any acceptable manipulations that can shorten routine testing time without affecting the requirement of the standard?

Thanks,
 
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Mike S.

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#3
I can't answer your question, looks like no one else here can, either.

Often a standard will contain contact information, I would contact the creator of the standard and ask your question. I have done this before with several standards and it can be very helpful.
 

Benjamin Weber

Trusted Information Resource
#4
There is no strict requirement for dielectric strength test in production lines, since 60601-1 is for type testing of the design/construction. IEC 62353 describes recurrent tests after repair. But there is no dielectric strength test. It's leakage currents, PE impedance, visual inspection and functional testing. Additionally there is inof on production line testing in IEC TR 62354, Annex K. Here a dielectric strength test is described, yet it only an informative annex, not normative.
 

Peter Selvey

Staff member
Super Moderator
#5
Agree with Benjamin, there should be no fixed requirement to test dielectric strength in production. Dielectric strength is actually an ageing test for solid insulation, and really intended to be applied to individual parts, not assembled devices.

The aging aspect is theoretically applicable, and could be used as an argument to avoid production testing since the test could damage or shorten the life of the insulation. However, virtually all modern insulation can hande far longer times than in the standard, so practically it's not an issue.

Rather, the bigger problem is that in an assembled device, there is a huge potential for voltage to be distributed in a way that damages parts not intended to act as safety insulating barriers. Also it's common that the parts providing safety insulation are not actually stressed in tests performed from outside an assembled device.

With that in mind, a high voltage test can still be a useful production test to check for assembly errors. In this case, the 60s time is not relevant, it just needs to be enough to be sure the voltage is reached reliably e.g. 5s. Even the voltage does not need to match the standard. Such a test should be carefully planned with designers involved to make sure it does not damage parts. Mains to earth is usually OK, but mains to secondary, patient circuits, accessible parts usually cannot be done, or should be done in sub-assemblies only (if not already done by the part supplier).
 
#6
If you have an NRTL report for Canada and the USA then dielectric strength testing is often a routine production test. The duration of the test aligns with the standard and it is a super quick and easy test to set up in a production line.
 
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