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Identifying Required Testing to comply with IEC 60601

K

kimovitch

#1
Hi,

I'm currently establishing the list of all testing and validation I have to realize on a Medical equipment to comply with the requirements of the IEC 60601. To do this I have to identify the standards that specify the test to be done (i.e EN 61010-1 for electrical safety). My typical problem is that I have to specify to the testing lab, the test I want.

Is there somewhere a list of all the test realated to the 60601? The objective would be to go through the list to identifiy what test is applicable or not.

Thank you for the inputs
 
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dr1vn

Involved In Discussions
#2
Depends on the testing house. Some of them will say we will look at your device and determine what tests are necessary and conduct those tests. This of course depends on the relationship you have with your testing house. There is a chance that they could be doing tests that may or may not be needed.

In the past I've just gone through the standard clause by clause (annoying, I know) and just determined what tests apply to my device. Then I send the clauses I want tested to the testing house and get a quote. Sometimes, the testing house will suggest other tests and their reasoning's for it so do what you will with the testing house's suggestions.

Our SOPs do not dictate any official/documented review of the standard, but if you are not comfortable with doing the review its a good idea to get a second opinion of the tests you think are appropriate by someone else in your company.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
One other thing you need to watch is where the device is going. Many if not most, countries require testing to be done by an accredited lab (ISO/IEC 17025:2005), accredited by an ILAC Signatory body. Some still accept just CBTL.
 
K

kimovitch

#5
Thank you all for your feedback. I was considering going through all clause of the 60601 and then identify the applicable test. I was hopping to do it the other way round, starting from a list of test specification.

Will see if I cannot find that
 
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