CISPR 11 - Assessment of Conformity

B

b_malone

Hello All,

Need a little assistance... I have been reading CISPR 11 Clause 12 specifically around the sampling to determine 80/80 for serial manufactured devices.

Should Clause 12 be followed to ultimately determine conformity to the standard? I am assuming yes...

Has anyone performed the statistical analysis identified by CISPR 11? If so how did you go about doing it. I came across CISPR 16-4-3 that described in more detail on how to do it, just wondering if anyone has used that as well.

I appreciate any guidance anyone can provide.

thank you
 
B

b_malone

Hi Pads38 thanks for taking the time to respond. Yes I saw that response when I first started looking into this...it doesn't quite answer what I am looking for.

We defined our medical equipment manufacturing process as serial so we need to follow the statistical assessment identified by clause 12 to demonstrate that our manufacturing method will be able to produce equipment with 80% confidence that 80% of the equipment will comply with the limits (80/80).

The problem we are having is it isn't very clear on how the analysis should be done. CISPR 16-4-3 is a technical report that provides guidance on how to do statistical analysis...just wondering if others did the same

...does your test house ask about your manufacturing method? just asking because i am curious if they apply Clause 12 when it comes determining compliance
 

Pads38

Moderator
In answer to your question - no our test house does not ask about our manufacturing methods.

Quite often we will put in "fixes" at the test house - things like added ferrites, extra earth bonding etc. - when that happens we work with the test house to make sure that the "fix" is something that is straightforward to implement in production.

So all our tests have been a single representative sample only.

There is another thread where this has been discussed here:
https://elsmar.com/elsmarqualityforum/threads/67656/

I believe that the situation is the same - all of the 60601 series are based on a type test of a representative sample of production.

I suppose that manufacturing variability is something that you may have to address in your risk management process.
 
Top Bottom