CEI EN 82304-1 : 1ED 2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
Hardcopy , PDF
English
01-03-2018
28-07-2025
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
Describes 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 |
Classificazione CEI 62-253. (05/2018)
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-3733-5
|
| Pages |
36
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 82304-1:2017 | Identical |
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