When is Risk Management required?
2. If a clause refer to RMP, then it is justified by the standard to use RMP to tailoring (adjust) concerned standard requirements to the DUT (device under test). This means in clear words: The RMP shall be conducted OR the defined technical standard requirements must be exactly fulfilled.
-Example: Clause 8.4.2.c (2Ed.: 16.e), here accessible voltages, e.g. 24Vdc could maybe be justified by RMP for home use (e.g. At a ceiling host –accessible current bus-bar), where it is ensured that the PATIENT has no catheters (intact skin) and can be regarded comparable to an OPERATOR.