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ISO/TS 82304

来源：泰然健康网时间：2025年08月01日 07:02

Reference number
ISO/TS 82304-2:2021

Technical Specification

ISO/TS 82304-2:2021

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

Edition 1
2021-07

Technical Specification

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ISO/TS 82304-2:2021

78182

Published (Edition 1, 2021)

This publication was last reviewed and confirmed in 2025. Therefore this version remains current.

Abstract

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.

Buy together

Health software

Part 1: General requirements for product safety

Bundle - 10% discount

Medical devices - the basics

This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

ISO 13485:2016 ISO 13485:2016 A practical guide ISO 14971:2019 ISO/TR 24971:2020

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General information

Publication date

: 2021-07

Stage

: International Standard confirmed [90.93]

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Life cycle

Now

Published

ISO/TS 82304-2:2021

A standard is reviewed every 5 years
Stage: 90.93 (Confirmed)

Preliminary

Proposal

Preparatory

Committee

Enquiry

Approval

Publication

Review

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ISO/TS 82304