Consolidated

IEC 62304:2006+AMD1:2015 CSV

Jun 2015 Current

Existing or new amendments and versions must be purchased separately.

Language English English/French

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Abstract

IEC 62304:2006+A1:2015 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. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.

Products specifications

Consolidated from IEC
Published: June 26 2015
Edition: 1.1
Document type: IS
Pages
ISBN: 9782832227657

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

IEC 62304:2006+AMD1:2015 CSV

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