I.S. EN 82304-1:2017
Current
The latest, up-to-date edition.
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
National Foreword
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
Pertains 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.
| Committee |
TC 62
|
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 82304-1:2017 | Identical |
| BS EN 82304-1:2017 | Equivalent |
| UNE-EN 82304-1:2017 | Equivalent |
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