Standard

IEC 62304:2006 ED1

May 2006 Current

Note: Latest version: IEC 62304:2006+AMD1:2015 CSV

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Amendment 1 - Medical device software - Software life cycle processes Current IEC 62304:2006/AMD1:2015 ED1 Amendment from Publication date: Jun 2015 Pages: 42 Language: English, English/French Services: Online, Online + Pdf

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. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

Products specifications

Standard from IEC
Published: May 9 2006
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: IEC
Distributor: IEC
ICS: 11.040.01
International TC: TC 62/SC 62A

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Version history Related Corrigenda and Amendments (1)

IEC 62304:2006/AMD1:2015 ED1

Version history History (2)

IEC 62304:2006+AMD1:2015 CSV