IEC 60601-1 - Medical Electrical Equipment Safety
Clause 14: programmable electrical medical systems – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 14.7: Requirement specification

What does 14.7 require?

A documented requirement specification exists for the PEMS and for every subsystem in it, and it contains, and marks out separately, whatever essential performance and risk control measures that system or subsystem implements.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 14: programmable electrical medical systems – IEC 60601-1 - Medical Electrical Equipment Safety

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.