ISO 14971 question

Hi Regarding the ISO 14971 question, there´s seems to be a misunderstanding. The risk analysis (a part of the whole risk management process described in ISO 14971) shall be made based on the normal use of the equipment (and single fault if deemed necessary). Two explanations follow. First, ISO

ISO 14971 question

Scanning the broad range of knowledge on theis list I have the following question: Does anyone know of a standard other than 60601-1-2 that untilizes ISO 14971 risk analysis under normal rather than single fault conditions? Thanks! Brent DeWitt Datex-Ohmeda Louisville, CO This message is fro