BS IEC 60747-5-4:2022

1   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](/search?q=ISO%209999) 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.