RO
SR EN 62304:2007/AC:2014
Medical device software - Software life-cycle processes
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 :
Withdrawn
Approval date : 10/31/2014
Withdrawal date : 9/30/2020
Number of pages : 3
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 22 - Electrical equipment in medical practice
- Replaced by SR EN 62304:2007