CEI EN IEC 81001-5-1

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CEI EN IEC 81001-5-1

2022

Most Recent

Health software and health IT systems safety, effectiveness and security Part 5-1: Security – Activities in the product life cycle

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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. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES. An informal overview of activities for HEALTH SOFTWARE.

The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves.

It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in ISO 81001-1[17].

This document excludes specification of ACCOMPANYING DOCUMENTATION contents.

CEI EN IEC 81001-5-1
STANDARD INFO:
Standard NameCEI EN IEC 81001-5-1
ScopeHealth software and health IT systems safety, effectiveness and security Part 5-1: Security - Activities in the product life cycle
PublisherCEI - Comitato Elettrotecnico Italiano
LanguagesEnglish
State[ Active ]
Publication Year2022
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
Edition22#
File Size1 file , 3.3 MB
Number of Pages66
Published10/01/2022
This document does not provide a preview.
CEI EN IEC 81001-5-1
HistoryPublisher Year

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