Standard

NEK IEC 62304:2006

May 2006 Published

Note: This standard has a new edition: NEK IEC 62304:2006+A1:2015 CSV

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Language English

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Amendment 1 - Medical device software - Software life cycle processes Published NEK IEC 62304:2006/AMD1:2015 Amendment from Publication date: Jun 2015 Version: 1 Pages: 52 Language: English Services: Read Online (No printing ), Printed and bound
Open product
Amendment 1 - Medical device software - Software life cycle processes Published NEK IEC 62304:2006/AMD1:2015 Amendment from Publication date: Jun 2015 Version: 1 Pages: 92 Language: English Services: Read Online (No printing ), Printed and bound

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.

Document information

Standard from NEK
Published: 9 May 2006
Edition: 1.0
Version: 1
Document type: NAT
Pages
ISBN:

ICS 11.040.01
National Committee NEK/NK62A+D (Arbeidsområdet ivaretas av NK62)

Product Relations

Merged into: NEK IEC 62304:2006+A1:2015 CSV
Adopted from: IEC 62304:2006

NEK IEC 62304:2006

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