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Publication detail

 
Reference IEC 62304 ed1.0 withdrawn corrigendum

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Title Versión Oficial En español - Software de dispositivos médicos. Procesos del ciclo de vida del software
Publication date 2006-05-09
Format, price
(Swiss francs)
and language
290.- 155 pages
290.- 891 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.
Technical Committee 62A - Common aspects of electrical equipment used in medical practice  RSS
ICS Codes
11.040 Medical equipment
 
Replaced by
Stability date 2015
 
Work in progress
ProjectStage codeForecast publication date
IEC 62304 Ed.2  A2CD2014-01-31
 
IEC 62304 Amd.1 Ed.1  ADIS2015-12-15
 


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