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.
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
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