IEC 62304:2006+AMD1:2015 - Medical device software - Software life cycle processes
Document: IEC 62304:2006+AMD1:2015
Official Source
Full Text
IEC 62304:2006+AMD1:2015 - Medical device software - Software life cycle processes
Source: https://webstore.iec.ch/en/publication/22794
Description
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.
Technical Committee: TC 62/SC 62A Common aspects of medical equipment, software, and systems
Keywords: Cyber security - Smart city
Publication type| International Standard
Publication date| 2015-06-26
Edition| 1.1
ICS| 11.040.01
Stability date| 2028
ISBN number| 9782832227657
Pages| 170
File size| 1.89 MB
**| | | | |