UNE-EN ISO 21856:2023

This International Standard specifies general requirements and test methods for assistive products intended for use to alleviate or compensate for a disability.The aim of this International Standard is to provide safety requirements and recommendations for manufacturers of such assistive products.This International Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.Where other International Standards exist for particular types of assistive products then those standards apply.NOTE 1 Assistive products may be considered to be medical devices in some jurisdictions but not in others.NOTE 2 Not all the items listed in ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of the standard can be used for assistive products which are not medical devices.