IEC 62304:2006

Medical device software — Software life cycle processes

Publication date: May 17, 2006

General information

Current stage: 90.20 Effective date: Jul 15, 2026

Originator: IEC

Owner: ISO/TC 210

Type: International Standard

ICS: 35.240.80 11.040.01

Languages: English French

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Status: Published

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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
90.20 Standard under periodical review
Jul 15, 2026

CORRIGENDA / AMENDMENTS

PUBLISHED
IEC 62304:2006/Amd 1:2015

REVISED BY

ABANDON
IEC/DIS 62304

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