ISO/TS 82304-2:2021 健康软件.第2部分：健康和健康应用程序的质量和可靠性

标准编号：ISO/TS 82304-2:2021

中文名称：健康软件.第2部分：健康和健康应用程序的质量和可靠性

英文名称：Health software — Part 2: Health and wellness apps — Quality and reliability

发布日期：2021-07

标准范围

本文件提供了健康应用程序的质量要求，并定义了健康应用程序质量标签，以便可视化健康应用程序的质量和可靠性。本文档适用于健康应用程序，这是一种特殊形式的健康软件。它涵盖了健康应用程序的整个生命周期。本文档旨在供应用程序制造商和应用程序评估组织使用，以传达健康应用程序的质量和可靠性。消费者、患者、护理人员、医疗保健专业人员及其组织、卫生当局、医疗保险公司和广大公众在推荐或选择医疗保健应用时，或在护理指南、护理路径和护理合同中采用医疗保健应用时，可以使用医疗保健应用质量标签和报告。注1:健康应用程序可能受到国家立法的约束，例如医疗设备。注2:有关范围的更多详细信息，请参见附录C。本文件范围之外的是遵守《医疗器械条例》的指南。

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.

标准预览图