International Electrotechnical Commission

Publication detail

Reference	IEC 62304 ed1.0 withdrawn corrigendum	> preview
Title	Medical device software - Software life cycle processes
Publication date	2006-05-09
Format, price (Swiss francs) and language	290.- 78 pages 290.- 651 Kb
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. This English-language version is derived from the original bilingual publication by leaving out all French-language pages. Missing page numbers correspond to the French-language pages.
Technical Committee	62A - Common aspects of electrical equipment used in medical practice
ICS Codes	11.040 Medical equipment
Replaced by
Stability date	2012
Work in progress	Project Stage code Forecast publication date IEC 62304 Ed.2  CDM 2014-01-31

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