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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
ICS Groups
11.040.01 Medical equipment in general 35.240.80 IT applications in health care technology
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.12.2021
Main
IEC 81001-5-1:2021
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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Standard monitoring
English (PDF 2 MB)

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Standards designation

EVSEstonian standard
ENEuropean standard (published by an CEN or CENELEC)
EN ISOInternational standard adopted as an European standard
ISOInternational Organization for Standardization’s standard
IECInternational Electrotechnical Commission’s standard
HDCENELEC’s harmonisation document
EVS-ENEuropean standard implemented in Estonia
EVS-EN ISOInternational standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IECInternational standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IECInternational electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
 
A, AMDamedment
+Aa full standard plus the amendment
/Aonly amendment
COR, ACcorrigendum
+CORa full standard plus the corrigendum
NAnational annex
+NAa full standard plus the national annex
/NAonly national annex
TStechnical specification
TRtechnical report
CWAagreement, developed by a CEN or CENELEC
prEVS-EN (etc)draft standard
 
etthe standard is in Estonian only
enthe standard is in English only
et-enthe standard is in Parallel text Estonian-English