Active standard | Published: 16/12/2021

IEC 81001-5-1-ed.1.0

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
(Logiciels de sante et securite, efficacite et surete des systemes TI de sante - Partie 5-1: Surete - Activites du cycle de vie du produit)

Available languages: English and French

Available design: electronic design (pdf), Print design, CD-ROM

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Detail information

Designation: IEC 81001-5-1-ed.1.0

Publication date: 16/12/2021

Pages: 114

Country: International technical standard

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Anotation

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. LIEC 81001-5-1:2021 definit les exigences de CYCLE DE VIE relatives au developpement et a la maintenance des LOGICIELS DE SANTE, necessaires pour venir a l’appui de la conformite a l’IEC 62443-4-1 – compte tenu des besoins specifiques pour les LOGICIELS DE SANTE. L’ensemble des PROCESSUS, ACTIVITES et TACHES decrits dans le present document etablit un cadre commun pour des PROCESSUS securises du CYCLE DE VIE DES LOGICIELS DE SANTE. Ces processus ont pour objet de renforcer la CYBERSECURITE des LOGICIELS DE SANTE par letablissement 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 equilibre approprie des proprietes cles (SECURITE, efficacite et SURETE) traitees dans l’ISO 81001-1. Le present document exclut la specification du contenu de la DOCUMENTATION D’ACCOMPAGNEMENT. Le contenu de la feuille dinterpretation 1 (2025-12) sapplique a la version anglaise uniquement.

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