IEC 62304:2006

Medical device software — Software life cycle processes

Publication date:   May 17, 2006

General information

90.93 Standard confirmed   Aug 20, 2021

IEC

ISO/TC 210 Quality management and corresponding general aspects for medical devices

International Standard

35.240.80   IT applications in health care technology | 11.040.01   Medical equipment in general

Buying

Published

Language in which you want to receive the document.

Scope


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.

Life cycle

NOW

PUBLISHED
IEC 62304:2006
90.93 Standard confirmed
Aug 20, 2021

CORRIGENDA / AMENDMENTS

Amended by
IEC 62304:2006/Amd 1:2015

REVISED BY

ABANDON
IEC/DIS 62304