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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
Translate name
STANDARD published on 16.12.2021
The information about the standard:
Designation standards: IEC 81001-5-1-ed.1.0
Publication date standards: 16.12.2021
SKU: NS-1045555
The number of pages: 114
Approximate weight : 373 g (0.82 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Medical equipment in generalIT applications in health care technology
Annotation of standard text IEC 81001-5-1-ed.1.0 :
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. 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.
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