19 Sep 2011

IEC 60601-1 is intended to serve as a tool in the risk management process. To that end, clause 4.2 specifies:

A risk management process according to ISO 14971 shall be performed. This means that certification to IEC 60601-1 is not possible without compliance with ISO 14971. However, certification to ISO 14971 is not required. A certificate for ISO 14971 is certainly a useful asset, but it does not exempt the safety test lab from having to verify compliance on a product basis (via the checklist in the CB Scheme Technical Report Form).

Do you have specific questions about risk management process? Or would you like to know more about specifics regarding the risk management file?

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