Standard

DS/EN 62304:2006

Software for medicinsk udstyr – Livscyklusprocesser for software

Status
Gældende Checkmark
Type
Standard
Varenummer
M212955
Udgivelsesdato
2006-11-28
Komite

CLC/TC 62

IEC/TC 62/SC 62A

Internationale relationer
Tooltip
IEC 62304:2006 ED1 IDT, EN 62304:2006 IDT
Dansk udvalg
Antal sider
88

Scope

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.