| Publication CODE |
Title |
| IEC 62304:2006+AMD1:2015 CSV (2015-06) |
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
848.00 €
|
170 P.. |
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.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2015-06-26 |
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| IEC publication date |
2015-06-26 |
| IEC stability date |
2020-12-31 |
| IEC file modification date |
2015-06-25 |
| IEC last modification date |
2019-10-31 |
|
