IEC 62304-ed.1.0

Detail information

Designation: IEC 62304-ed.1.0

Publication date: 09/05/2006

Pages: 155

Country: International technical standard

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Anotation

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. 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.