IEC 81001-5-1:2021 PRV 
Pre release version

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

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Abstract

This Final Draft International Standard is an up to 6 weeks' pre-release of the official publication. It is available for sale during its voting period: 2021-09-10 to 2021-10-22. By purchasing this FDIS now, you will automatically receive, in addition, the final publication.

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.

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Additional information

Publication typeInternational Standard
Publication date2021-09-10
Edition1.0
Available language(s)English
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Stability date  2026
Pages56
File size1618 KB

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