IEC 62304:2006

Title

Language: EN Medical device software - Software life cycle processes

Language: FR Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel

Abstract

Language: EN 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.

Language(s)
Language: FR
Edition
1.0
Date of issue
09.05.2006
TC 62/SC 62A
ICS Codes
11.040.01
Publication number
62304
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Mandatory Standard according current regulation Mandatory Standard according current regulation

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