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IEC 81001-5-1

IEC 81001-5-1:2021
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.
BASE PUBLICATION
English/French

Technical committee

TC 62/SC 62A Common aspects of medical equipment, software, and systems

Category

Safety - Information security and data privacy
Publication typeInternational Standard
Publication date2021-12-16
Edition1.0
ICS

11.040.01

35.240.80

Stability date2026
ISBN number9782832255780
Pages114
File size2.58 MB
EditionDatePublicationEditionStatus
  • Ensure healthy lives and promote well-being for all

  • Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation

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