NEK IEC 62304:2006+A1:2015 CSV

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Norsk tittel: Medical device software - Software life cycle processes
Engelsk tittel: Medical device software - Software life cycle processes
Varetype: Standard
Språk: Engelsk
Utgave: 1.1 (2015-06-26)
Erstatter: NEK IEC 62304:2006 Check Gyldig
NEK IEC 62304:2006/AMD1:2015 Check Gyldig
NEK IEC 62304:2006 Check Gyldig
NEK IEC 62304:2006/AMD1:2015 Check Gyldig
Antall sider: 180
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NOK 7 958,00 (eks. mva)
NOK 9 947,50 (ink. mva)

Omfang: 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.
Fastsatt: 2015-06-26
ICS: 11.040 - Medisinsk utstyr
11.040.01 - Medisinsk utstyr generelt