What are the duties of the test house in respect to RMF?

Checking projects for compliance with EN 60601-1:2006 (incl. applicable collateral and particular standards) requires a 100% verification of all applicable clauses of that standard. This includes all those clauses which refer to RM.

If the manufacturer deviates from any of the verifiable requirements of the standard, he must demonstrate equivalent safety (see clause 4.5), usually the outcome of the risk management process, to be verified by the test house.

For new hazards, e.g. associated with innovative technology, the manufacturer has the duty to include them in his risk management process and also has to work with the test house for proper verification. Clause 4.5 is not applicable for such hazards.



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