CEI EN 82304-1 : 1ED 2018
Current
The latest, up-to-date edition.
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
Hardcopy , PDF
English
13-05-2018
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
0
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| EN 82304-1:2017 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.