| Publication CODE |
Title |
| IEC 82304-1:2016 (2016-10) |
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
201.00 €
|
55 P.. |
Description
IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers.
It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
|
| 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 |
2016-10-27 |
| ICS-Code (International Standards Classification) |
35.240.80
|
| NBN Status |
New |
|
| IEC publication date |
2016-10-27 |
| IEC stability date |
2022-12-31 |
| IEC file modification date |
2016-10-27 |
| IEC last modification date |
2019-10-31 |
|
