EN
SR EN 62304:2007/AC:2014
Software pentru dispozitive medicale. Procesele ciclului de viaţă ale software-ului
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.
Status :
Anulat
Data aprobării : 31.10.2014
Data anulării : 30.09.2020
Număr de pagini : 3
ICS : 11.040.01 Echipament medical în general
Comitet tehnic : 22 - Echipamente electromedicale
- Inlocuit prin SR EN 62304:2007