Verkkokauppa
CEN ISO/TS 82304-2:2021:en
Health software. Part 2: Health and wellness apps. Quality and reliability (ISO/TS 82304-2:2021)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
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Tässä julkaisussa ei ole velvoittavia viittauksia
Tekninen komitea
Vahvistuspäivä
20.08.2021
Julkaisupäivä
24.08.2021
Painos
1
Sivumäärä
85
Julkaisun kieli
englanti