Routine Testing for Class I Medical Device

Kuldeep Singh

Involved In Discussions
#21
Hello ,

Is it required to perform all the performance test such as dielectric strength test, leakage current test as specified in IEC 60601-1 on each and every machine at line assembly during its quality stage?

Yesterday during an audit , NB ask to perform the leakage current test on each machine. We are assuming that these tests shall perform only on prototype machine. Reference to above threads , it will also affect the performance of device if we perform these tests on device before its shipment.

At present we have leakage current tester designed to satisfy the IEC 60601-1 Cl. 8.7 requirement, which is costly equipment and kept in our Laboratory for performing the test on prototype machine. It will affect economically to us if we are bounded to provide this equipment in each halls to perform this test. Do you suggest any alternate & cheapest method to check the leakage current .
 
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Peter Selvey

Staff member
Moderator
#22
Is it required to perform all the performance test such as dielectric strength test, leakage current test as specified in IEC 60601-1 on each and every machine at line assembly during its quality stage?

No.

When you declare compliance with standards like IEC 60601-1, this applies in both design and production. In fact, compliance in production is the real target for medical device regulations.

However, this does not mean testing every machine for compliance. This would be impractical, expensive and unnecessary.

Usually, for each requirement, the production engineers will take into account:

- the nominal or typical value
- the margins to safe limits
- the expected variability for each item in production
- possible failures in production (parts miss, assembly mistakes)
- the criticality of the requirement

Generally, in the case of dielectric strength and leakage currents, although they are "critical", the margins will be high and the variability low. So, the only reason to do the test in production would be to detect an assembly failure. Since that is the focus, the tests can be greatly simplified and do not need to follow IEC 60601-1 exactly.

For example, if you have a ac dielectric strength tester with 0.01mA resolution, it's possible to use that as a proxy for leakage current, rather than doing an actual leakage current test.

The most critical point is to make sure you have a qualified engineer designing the tests in production. They should have the confidence to explain why they selected the tests that are performed, and also argue against NB auditors.

The NB should never insist that a manufacturer do certain tests in production. Many of the tests in IEC 60601-1 are destructive or invasive, and would invalidate warranties if performed.

The NB can only ask how the manufacturer assures that each item (machine) in production meets the standard.
 

Kuldeep Singh

Involved In Discussions
#23
Thanks Peter , that's what we are looking for, let see what are the opinion of other members.

Can you suggest me how to check the Earth leakage current with dielectric strength tester. As per my understanding, Dielectric strength tester is used for insulation and leakage current tester is for checking the leakage current in line, surface of enclosure and applied part.
 

Peter Selvey

Staff member
Moderator
#24
In production, dielectric strength is not actually required, since it is really an ageing test for solid insulation (it's a frequently misunderstood test).

It can be used to check gross assembly errors and other production mistakes such as a dropped screw. In this case it's really just a high voltage test (HV test).

The main HV test you should be doing in production is a mains to earth (1.5kVrms). This is a simple test and in practice non-destructive, and useful for detecting gross mistakes. The other tests (mains to enclosure, mains to applied part etc.) are often destructive and may need special preparation of the sample to perform, it would be far more dangerous to do this on production items than any benefit from the test.

For the mains to earth test, the leakage during the test should be about 6 times the earth leakage when measured with the neutral open. For example, assume the device has two 1nF EMC capacitors, one L-E, one N-E (typical EMC filter), and no other major parts for earth leakage. In this case, we expect to see about 0.1mA earth leakage in normal condition @253V 60Hz and 0.2mA with the "neutral open" (this condition puts both the capacitors parallel, so double leakage). Then in the high voltage test, we would expect to see roughly 6 times this value (1.2mA). Thus we can use the HV test as a proxy for the earth leakage current test, in the sense that we are just looking for gross assembly errors. For example, if the result came back as 2.5mA, you could predict that someone put the wrong EMC capacitors in.

The circuit for earth leakage is also very simple, so it's not much work to make a simple low cost jig for this test as another option.

Again, I should stress, all of this should be organized by a qualified electrical engineer familiar with both the tests, your particular device and possible failure modes in production. There can be for example, special cases such as electrosurgical devices where the high voltages in the patient circuit would make a production HV test reasonable.
 

Tidge

Quite Involved in Discussions
#25
Thanks Peter , that's what we are looking for, let see what are the opinion of other members.
For what it is worth, I agree with Peter.

Again, I should stress, all of this should be organized by a qualified electrical engineer familiar with both the tests, your particular device and possible failure modes in production.
In my opinion, this good advice about seeking qualified engineers to design appropriate tests (quoted above) extends beyond this specific instance. Ideally, manufacturing processes (as well as products) are supposed to be 'engineered' so as to only perform testing which provides value. Testing which exposes manufacturing defects that occur at a known rate (and cannot be avoided) is much more preferred than repeating verification testing of every unit manufactured.
 
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