I.S. EN IEC 81001-5-1:2022
Current
The latest, up-to-date edition.
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (IEC 81001-5-1:2021)
Hardcopy , PDF
English
28-02-2022
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.
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FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Software development PROCESS
6 SOFTWARE MAINTENANCE PROCESS
7 SECURITY RISK MANAGEMENT PROCESS
8 Software CONFIGURATION MANAGEMENT PROCESS
9 Software problem resolution PROCESS
Annex A (informative) Rationale
Annex B (informative) Guidance on implementation of SECURITY LIFE CYCLE ACTIVITIES
Annex C (informative) THREAT MODELLING
Annex D (informative) Relation to practices in IEC 62443-4-1:2018
Annex E (informative) Documents specified in IEC 62443-4-1
Annex F (normative) TRANSITIONAL HEALTH SOFTWARE
Annex G (normative) Object identifiers
Bibliography
This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for HEALTH SOFTWARE into account.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-1053-7
|
| Pages |
128
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN IEC 81001-5-1:2022 | Identical |
| IEC 81001-5-1:2021 | Identical |
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