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IEC 81001-5-1 Ed. 1.0 b:2021

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
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IEC 81001-5-1 Ed. 1.0 b:2021

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

PUBLISH DATE 2021
PAGES 118
IEC 81001-5-1 Ed. 1.0 b:2021
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 defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1 – 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.
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.
This document excludes specification of ACCOMPANYING DOCUMENTATION contents.
SDO IEC: International Electrotechnical Commission
Document Number IEC 81001
Publication Date Dec. 1, 2021
Language b - English & French
Page Count 118
Revision Level 1.0
Supercedes
Committee 62A
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