Norme internationale
ISO/TS 82304-2:2021
Logiciels de santé — Partie 2: Applications de santé et de bien-être — Qualité et fiabilité
Numéro de référence
ISO/TS 82304-2:2021
Edition 1
2021-07
Norme internationale
Prévisualiser
ISO/TS 82304-2:2021
78182
Indisponible en français
Publiée (Edition 1, 2021)

ISO/TS 82304-2:2021

ISO/TS 82304-2:2021
78182
Langue
Format
CHF 194
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Résumé

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.

Informations générales

  •  : Publiée
     : 2021-07
    : Norme internationale publiée [60.60]
  •  : 1
  • ISO/TC 215
    35.080  35.240.80 
  • RSS mises à jour

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