Elektromedicinski uređaji — Deo 1-4: Opšti zahtevi za bezbednost — Dodatni standard: Programabilni električni medicinski sistemi

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

Ovim standardom specificiraju se zahtevi za proces uz čiju pomoć se projektuje programabilni električni medicinski sistem. Služi kao osnova za zahteve u posebnim standardima, služeći kao uputstvo za zahteve za bezbednost, čija je svrha da se smanji rizik i upravlja rizikom. Ovaj standard obuhvata specifikaciju zahteva, strukturu, detaljni projekat i realizaciju softvera.

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.

SRPS EN 60601-1-4:2010 zamenjuje SRPS IEC 60601-1-4:1999 - 30.12.2010

medicinski uređaji, programabilni električni medicinski sistemi, bezbednost