EN 82304-1:2017
Current
Health Software - Part 1: General requirements for product safety
09-01-2017
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 HEALTH SOFTWARE PRODUCT requirements
5 HEALTH SOFTWARE - Software life cycle processes
6 HEALTH SOFTWARE PRODUCT VALIDATION
7 HEALTH SOFTWARE PRODUCT identification and
ACCOMPANYING DOCUMENTS
8 Post-market activities for the HEALTH SOFTWARE
PRODUCT
Annex A (informative) - Rationale
Bibliography
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
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.
| Committee |
CLC/TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Standards | Relationship |
| NF EN 82304-1 : 2017 | Identical |
| NEN EN IEC 82304-1 : 2017 | Identical |
| PN EN 82304-1 : 2017 | Identical |
| I.S. EN 82304-1:2017 | Identical |
| BS EN 82304-1:2017 | Equivalent |
| DIN EN 82304-1:2018-04 | Identical |
| VDE 0750-102-1:2018-04 | Identical |
| UNE-EN 82304-1:2017 | Identical |
| CEI EN 82304-1 : 1ED 2018 | Identical |
| BS EN 82304-1:2017 | Identical |