IEC 62304:2006

This standard was last reviewed and confirmed in 2021. Therefore this version remains current.

Abstract

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.

General information

Status
: Published

Publication date
: 2006-05
Edition
: 1

Number of pages
: 151
Technical Committee
: ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
ICS
:
11.040.01 Medical equipment in general

35.240.80 IT applications in health care technology

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	Format	Language
std 1 330	Paper
std 2 330	PDF

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Life cycle

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Published

IEC 62304:2006

A standard is reviewed every 5 years
Stage: 90.93 (Confirmed)
Corrigenda / Amendments

Published

IEC 62304:2006/Amd 1:2015

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