IEC 81001-5-1:2021
2021-12
Resumen
This document 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.
Comprar juntas
Productos sanitarios: los básicos
Este paquete agrupa las normas ISO esenciales para brindar un marco sólido para la gestión de la calidad y la gestión de riesgos en la industria de productos sanitarios.
- ISO 13485:2016
- Guía práctica sobre ISO 13485:2016
- ISO 14971:2019
- ISO/TR 24971:2020
Informaciones generales
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Estado: PublicadoFecha de publicación: 2021-12Etapa: Norma Internacional publicada [60.60]
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Edición: 1
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Comité Técnico :ISO/TC 215
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