Standard

NS-EN ISO 21856:2022

Aug 2022 Published

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Language English

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Abstract

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.

Document information

Standard from SN
Published: 3 August 2022
Edition: 2022-07
Version: 1
Document type: NAT
Pages
ISBN:

ICS 11.180.01
National Committee SN/K 106

Product Relations

Replaces: NS-EN 12182:2012
Replaces: NS-EN ISO 16201:2006
Adopted from: EN ISO 21856:2022, 0

NS-EN ISO 21856:2022

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