IEC 60601-1 - Medical Electrical Equipment Safety
Clause 4-5: General Requirements and Testing

IEC 60601-1 - Medical Electrical Equipment Safety 1.4.1: General requirements

Mandates ISO 14971 risk management techniques and defines Essential Performance and Single Fault Safety principles

Other controls in Clause 4-5: General Requirements and Testing

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.