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IEC 81001-5-1:2021

(Main)

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

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.

Logiciels de santé et sécurité, efficacité et sûreté des systèmes TI de santé - Partie 5-1: Sûreté - Activités du cycle de vie du produit

L'IEC 81001-5-1:2021 définit les exigences de CYCLE DE VIE relatives au développement et à la maintenance des LOGICIELS DE SANTE, nécessaires pour venir à l’appui de la conformité à l’IEC 62443-4-1 – compte tenu des besoins spécifiques pour les LOGICIELS DE SANTE. L’ensemble des PROCESSUS, ACTIVITES et TACHES décrits dans le présent document établit un cadre commun pour des PROCESSUS sécurisés du CYCLE DE VIE DES LOGICIELS DE SANTE.
Ces processus ont pour objet de renforcer la CYBERSECURITE des LOGICIELS DE SANTE par l'établissement de certaines ACTIVITES et TACHES dans les PROCESSUS DU CYCLE DE VIE desdits LOGICIELS, ainsi que par le renforcement de la SURETE des PROCESSUS DU CYCLE DE VIE DES LOGICIELS proprement dit.
Il est important de maintenir un équilibre approprié des propriétés clés (SECURITE, efficacité et SURETE) traitées dans l’ISO 81001-1.
Le présent document exclut la spécification du contenu de la DOCUMENTATION D’ACCOMPAGNEMENT.

General Information

Status
Published
Publication Date
15-Dec-2021
ICS
11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Technical Committee
SC 62A - Common aspects of medical equipment, software, and systems
Drafting Committee
JWG 7 - TC 62/SC 62A/JWG 7
Current Stage
PPUB - Publication issued
Start Date
24-Dec-2021
Completion Date
16-Dec-2021
Ref Project

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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 cycleIEC 81001-5-1:2021 - 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 81001-5-1:2021 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
English and French language
114 pages
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IEC 81001-5-1
Edition 1.0 2021-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Health software and health IT systems safety, effectiveness and security –
Part 5-1: Security – Activities in the product life cycle

Logiciels de santé et sécurité, efficacité et sûreté des systèmes TI de santé –
Partie 5-1: Sûreté – Activités du cycle de vie du produit

IEC 81001-5-1:2021-12(en-fr)

---------------------- Page: 1 ----------------------
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