IEC 60601-1-2 - EMC Retesting Rational - Minor Component Changes

A

AmirBaron

#1
Hi,
We currently have medical device that has been tested and approved to the FDA recognized standards.
My question is: Do I have to retest the EMC tests (60601-1-2) on every minor change in the hardware such as :Capacitors or resistors value or manufacturer.
is writting a rational enough in that case?
Do I have to involve my 3rd part laboratry with every change?
How do I know in which product change I must retest the EMC?
Is there any refernece about that issue in the standard?

Thanks
 
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Marcelo

Inactive Registered Visitor
#2
You questions relates to the regulatory aspect of the process, so there´s nothing on this on any standard.

Do I have to retest the EMC tests (60601-1-2) on every minor change in the hardware such as :Capacitors or resistors value or manufacturer.
It depends on which regulatory system you´re asking about. In general, changes that affect safety have to be analised and may need additional verification/validation, so you would need to retest (this also relates to what is your goal with testing). FDA and CE Marking (there´s a new NB-MED about this) have guidelines related to twhat to do with modifications.

Is writting a rational enough in that case?
The answer is the same as above. FDA for example has what is called a "Letter to file" regarding rationalizing changes... please see the following thread for links: http://elsmar.com/Forums/archive/index.php/t-24190.html

Do I have to involve my 3rd part laboratry with every change?
It depends on the system. If your third party is a certification body, for example which gives you a mark, you will also need to take into account the requirements for the mark.

How do I know in which product change I must retest the EMC?
Generally this is a type testing which must be done in a representative sample.

Is there any refernece about that issue in the standard?
As i said before, no.
 
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