ISO 21856:2022 辅助产品 一般要求和试验方法

标准编号：ISO 21856:2022

中文名称：辅助产品 一般要求和试验方法

英文名称：Assistive products — General requirements and test methods

发布日期：2022-07

标准范围

本文件规定了用于缓解或补偿残疾的辅助产品（被视为医疗器械）的一般要求和测试方法。本文件不适用于通过向用户施用药物达到其预期目的的辅助产品。注意1.在某些司法管辖区，辅助产品被视为医疗器械，但在其他司法管辖区则不被视为医疗器械。注意2.其他国际标准中给出了特定类型辅助产品的要求和测试方法，例如参见参考[33].注意3.并非ISO 9999中列出的所有项目都是医疗设备。缔约方可能希望考虑本文件或具体条款或子条款是否可用于非医疗器械的辅助产品。

This document specifies general requirements and test methods for assistive products, considered to be medical devices, intended for use to alleviate or compensate for a disability.This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.NOTE 1    Assistive products are considered to be medical devices in some jurisdictions but not in others.NOTE 2    Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33].NOTE 3    Not all the items listed in ISO 9999 are medical devices. Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices.

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