20/30350184 DC - BS EN ISO 21856. Assistive products. General requirements and test methods

20/30350184 DC

BS EN ISO 21856. Assistive products. General requirements and test methods

Status : Current, Draft for public comment   Published : April 2020



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.


Assistive products may be considered to be medical devices in some jurisdictions but not in others.


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.

Standard Number20/30350184 DC
TitleBS EN ISO 21856. Assistive products. General requirements and test methods
StatusCurrent, Draft for public comment
Publication Date02 April 2020
Normative References(Required to achieve compliance to this standard)ISO 12100, ISO 13849, IEC 82079-1, ISO 14155, ISO 11607-1, ISO 5349-2, ISO 14971, ISO 13732-1, IEC 60695-11-10, ISO 10993-1, ISO 3746, ISO 17966, EN 597-1, IEC 62311, ISO 15223-1, ISO/DIS 20417, ISO 13485, IEC 80601-2-35, EN 597-2, ISO/DIS 21801-1, EN/ISO 20417, ANSI UL 2900-2-1, ISO 13850, ISO 24415-1, ISO 24415-2, IEC 60332-1-2, EN 716-2:2008, ISO 9999, ISO 2631-1, IEC 60601-1-9, ISO 5349-2, ISO 5349-1, ISO 9227, EN 894-3
International RelationshipsISO/DIS 21856
Draft Expiry Date19 May 2020
DescriptorsElectromagnetic compatibility, Temperature, Equipment safety, Medical equipment, Overflows, Biocompatibility, Electrical safety, Mechanical testing, Flammability, Hazards, Sterilization (hygiene), Battery housings, Bedding, Battery-powered devices, Ergonomics, Packaging, Risk analysis, Corrosion resistance, Leak tests, Aids for the disabled, Vibration hazards, Mattresses, Performance, Noise control (acoustic), Cleaning, Furnishing fabrics
Title in FrenchProduits d’assistance — Exigences générales et méthodes d’essai
File Size1.217 MB
NotesWarning: this draft is not current beyond its expiry date for comments.

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