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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

General information
Valid from 16.12.2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
16.12.2021
Main
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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