Routine Testing for Class I Medical Device




For one of our product (class I device) we have already done type testing as per IEC 60601-1.

For doing routine testing in all our products before dispatching whether we need to do high voltage testing(dielectric test) and insulation resistance (IR test) testing as per 60601-1 std. or shall we define our own routine tests keeping 60601-1 and 62353 as reference??

please help.

Thank you in advance


The tests and requirements set out in 60601-1 are, as you identify, Type Tests.

It is generally understood that some of these tests can be damaging to the unit under test. For instance, the impact test tends to dent panels and the marking durability tests can scuff labels. Neither necessarily constitutes test failure - but leave the unit in an unsaleable condition.

This accumulation of damage is why the sequence of tests (see Annex B) is defined. Your device should still be functional and safe after all he tests have been completed - but it may look a little worse for wear.

The dielectric strength test places significant stress upon electrical insulation. It may even permanently damage the insulation. And that damage may not be visible. So, it is not possible to guarantee that a test unit has undamaged insulation - so should never enter the market.

So what tests should be used on production?

Clause 5.1 describes the use of Type Tests. The 'Note 2' to that clause identifies IEC 62354 Annex K as guidance for 'Production Tests' and IEC62353 as guidance for 'Recurrent Tests'. Both have alternate methods for both the dielectric tests and various leakage current tests.

The guidance rationale for Clause 5.1 is useful:
Production tests need not be identical with TYPE TESTS, but can be adapted to manufacturing conditions and possibly invoking less RISK for the quality of the insulation or other characteristics...

One option for the dielectric tests that is quite commonly used, for instance by manufacturer's of transformers, is to perform the full voltage, full 1 minute, test on a sample to 'Type Test' it but then, for production, test at full voltage - but only for 5 seconds. This is, basically, the test we perform for production.

One thing to highlight - the dielectric strength tests only apply to solid insulations. If you are using 'creepage and clearance' insulations then you use a ruler as your test equipment - not the dielectric tester!

Also, when it comes to production dielectric tests, it is often a mistake to test from the 'back to the front'. By that I mean testing from the mains input to the front panel connectors. What happens then is that the test voltage stress is applied across more than one insulation and will be 'shared out' unevenly and unpredictably.


Involved In Discussions
What are the requirements for dielectric tests during production? I have had conflicting information. As an example, the test house that certified a product for 60601 requires us to test with full voltage (1500 VAC) for 60 seconds (3000 VAC for applied parts to mains). The notified body that audits us to keep our CE certification tells us we are testing it too long and could damage the insulation. They recommend 5 seconds. :confused:


The test house is only used to doing Type Tests - hence their suggestion of 60s dielectric test.

For the production test 5 seconds is preferable. But, even then, make sure that you are only testing solid insulation and you are not stressing parallel insulations (where the test voltage would be unevenly divided).


Involved In Discussions
Thanks Pads.

What I have been told now is that it can be tested for a shorter period of time, but at a higher voltage. (1000 + 2x line rating) * 1.2 for 1 second. (1776V, since they are using 230 VAC in the calculation, rather than 250V)



If testing at hipot for 5 seconds, what IEC standard would support this time frame?

I've seen hipot being applied to production line units for 60 seconds and I think that's too long. I need some sort of "official" reference I can point to before I can suggest shortening that dwell time. Any suggestions on what document I can use as reference?




Hi Randy and welcome to the forums.

The 'Type Tests' for medical electrical equipment are what is in IEC 60601-1 (plus collateral and particular parts).

For 'Production Tests' the technical report IEC 62354 provides guidance.

For 'Recurrent Tests' (perhaps those done by a hospital's equipment management service each year) the technical report IEC 62353 provides guidance.



it would be of great help if any body could share a copy of IEC 62354 standard.

Thank you


Inactive Registered Visitor
<snip> it would be of great help if any body could share a copy of IEC 62354 standard.

Any deliverable from IEC (IEC TR 62354 is in fact not a standard, but a technical report) is copyrighted and must be bought. Please refrain from asking for pirated copies of copyrighted material in this forum.
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