Safety Tests Required for In-Process Testing of Medical Devices

C

cdewitt

#1
Assuming a device is properly designed and has been tested to meet all IEC 60601 requirements, what kind of safety testing should be done in production and after service?

Thanks for your help,

Chris
 
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yodon

Staff member
Super Moderator
#2
Re: What Safety tests are required for In-process testing of medical devices ?

If the device is electrical, I believe the test labs may require dielectric strength testing. There may be others based on the device type; I'm not sure.

Otherwise, it's up to you to decide. You need to ensure you are producing safe and effective product (always aligned with the device that passed safety testing) so you may need to define in-process tests to ensure this. A process FMEA can really help identify areas where your manufacturing process may go south and you can put in tests and controls to ensure quality (and safety) all along the way.

Similar with servicing: you need to confirm the device remains compliant with requirements (and thus safe) after servicing. It's up to you to decide what that means. Be prepared to defend your decisions so, again, a pFMEA might help guide the rationalization of testing to do (or not to do).
 
#3
You might like to refer to IEC 62353 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

It was created when it was realised that the full 60601-1 type tests are not always suitable for in-service and recurrent testing.

A handy (and free) guide to 62353 can be got from www.rigelmedical.com (no connections other than a user of their test equipment).
 
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