IEC 60601-1-4:1996 ED1

Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems IEC 60601-1-4:1996 ED1

Publication date:   May 31, 1996

Scope

Specifies requirements for the process by which a programmable
electrical medical system is designed. Serves as the basis of
requirements of Particular Standards, including serving as a guide
to safety requirements for the purpose of reducing and managing
risk.This standard covers requirement specification, architecture,
detailed design and implementation software development,
modification, verification and validation, marking and accompanying
documents.