EBME Forums Forums Management Medical Equipment Management IEC CERTIFICATION

I'm wondering if IEC compliance certificate have expiry? how about IP or Ingres protection compliance certificate have validity also?

IEC standards for products are used as a route to regulatory conformance. No one issue an IEC certification for products, but they might be quoted when certifying to a medical device regulation (e.g. EU MDD or MDR).

Clearly any IP Ingress rating is subject to being maintained according to the manufactures instructions for use (IFU). Also, the product certification is only valid for the period specified in the IFU, once the stated expected life has elapsed then continued use is at the risk of the user.

..yes we know that IEC particular 60601 is the benchmark of all medical devices. we add and require a IEC certificate as conformance to the technical specification when we buy new medical equipment.we also include CE markings,CMDN or CMDR also IP ratings..my problem is how many years is the validity of this regulations?

oh by the way..CMDN stand for Certificate of medical device notification and CMDR certificate of medical device registration.