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
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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