ISO-21856 › Assistive products - General requirements and test methods
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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.
To find similar documents by classification:
11.180.01 (Aids for disabled and handicapped persons in general)
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Document Number
ISO 21856:2022
Revision Level
1ST EDITION
Status
Current
Publication Date
July 1, 2022
Committee Number
ISO/TC 173