ISO 21856:2022

Assistive products — General requirements and test methods ISO 21856:2022

General information

60.60 Standard published   Jul 4, 2022

ISO

ISO/TC 173 Assistive products

International Standard

11.180.01   Aids for disabled and handicapped persons in general

Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 16201:2006

NOW

PUBLISHED
ISO 21856:2022
60.60 Standard published
Jul 4, 2022