Resumen
This document provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps.
This document is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps.
This document is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts.
NOTE 1 Health apps can be subject to national legislation, such as for medical devices.
NOTE 2 See Annex C for additional details on the scope.
Outside the scope of this document are guidelines to comply to the medical device regulation.
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: 2021-07Etapa: Cierre de la revisión [90.60]
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Edición: 1Número de páginas: 78
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Comité Técnico :ISO/TC 215
- RSS actualizaciones
Ciclo de vida
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Ahora
PublicadoISO/TS 82304-2:2021
Las normas se revisan cada 5 años
Etapa: 90.60 (En proceso de revisión)
