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Norm

ISO 21856:2022

Issue date: 2022 07 04

Assistive products — General requirements and test methods

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 ...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 54 Pages
Language:
English

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.

ISO 21856:2022
2022 07 04
Assistive products — General requirements and test methods
Norm
ISO 16201:2006
2006 09 27
Technical aids for persons with disability — Environmental control systems for daily living
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