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IEC 62304-ed.1.1+Amd.1-CSV
Medical device software - Software life cycle processes
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STANDARD published on 26.6.2015
The information about the standard:
Designation standards: IEC 62304-ed.1.1+Amd.1-CSV
Publication date standards: 26.6.2015
SKU: NS-1096045
The number of pages: 170
Approximate weight : 541 g (1.19 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 62304-ed.1.1+Amd.1-CSV :
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. LIEC 62304:2006+A1:2015 definit les exigences du cycle de vie des logiciels de dispositifs medicaux. Lensemble des processus, activites et taches decrit dans la presente norme constitue un cadre commun pour les processus du cycle de vie des logiciels de dispositifs medicaux. Sapplique au developpement et a la maintenance des logiciels de dispositifs medicaux lorsque le logiciel est un dispositif medical ou lorsque le logiciel est incorpore ou fait partie integrante du dispositif medical final. La presente norme ne couvre pas la validation et la mise sur le marche du dispositif medical, meme lorsque le dispositif medical est integralement constitue du logiciel. Cette version consolidee comprend la premiere edition (2006) et son amendement 1 (2015). Il nest donc pas necessaire de commander lamendement avec cette publication.
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