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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

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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

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

CORRIGENDA / AMENDMENTS

PUBLISHED
IEC 62304:2006/Amd 1:2015

REVISED BY

ABANDON
IEC/DIS 62304