ISO/TS 82304-2:2021

Health software — Part 2: Health and wellness apps—Quality and reliability

Kehtiv alates 30.07.2021
Direktiivid või määrused
Standardi ajalugu
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.
197,77 € koos KM-ga
197,77 € koos KM-ga
Standardi monitooring
Teised on ostnud veel

ISO 15223-1:2021

Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
Uusim versioon Kehtiv alates 06.07.2021

EVS-EN 82304-1:2017

Meditsiinitarkvara. Osa 1: Põhinõuded toote ohutusele
Uusim versioon Kehtiv alates 18.09.2017

EVS-EN ISO 20417:2021

Meditsiiniseadmed. Tootja esitatav teave
Uusim versioon Kehtiv alates 17.05.2021
Põhitekst + muudatus

EVS-EN 60601-1-11:2015+A1:2021

Elektrilised meditsiiniseadmed. Osa 1-11: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Nõuded koduses ravikeskkonnas kasutatavatele elektrilistele meditsiiniseadmetele ja -süsteemidele
Uusim versioon Kehtiv alates 17.08.2021