Verkkokauppa
SFS-EN 62304:en
Medical device software - Software life-cycle processes
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SESKO ry, puh. 050 571 6048.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SESKO ry, puh. 050 571 6048.
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Tekninen komitea
Direktiivi
90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
http://ec.europa.eu »
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
http://ec.europa.eu »
Vahvistuspäivä
22.01.2007
Julkaisupäivä
01.03.2016
Painos
1
Sivumäärä
86
Julkaisun kieli
englanti