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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

Edition date: 2021-12-16
In Force
Available languages: English, French
Summary: 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.
The contents of the Interpretation sheet 1 (2025-12) have been included in this copy.

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.
Le contenu de la feuille d'interprétation 1 (2025-12) s'applique à la version anglaise uniquement.
ICS: 35.240.80-IT applications in health care technology, 11.040.01-Medical equipment in general
CTN: TC 62/SC 62A - 1359

Modificaciones Normas

Es interpretada por IEC 81001-5-1:2021/ISH1:2025

Otras Relaciones

Acuerdo de Frankfurt FprEN IEC 81001-5-1:2021

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