NF EN ISO 21856

NF EN ISO 21856

July 2022
Standard Current

Assistive products - General requirements and test methods

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.

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Main informations

Collections

National standards and national normative documents

Thematics

Accessibilité

Publication date

July 2022

Number of pages

66 p.

Reference

NF EN ISO 21856

ICS Codes

11.180.01   Aids for disabled and handicapped persons in general

Classification index

S96-301

Print number

1

International kinship

ISO 21856:2022

European kinship

EN ISO 21856:2022
Sumary
Assistive products - General requirements and test methods

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.

Replaced standards (2)
NF EN 12182
August 2012
Standard Cancelled
Assistive products for persons with disability - General requirements and test methods

Le présent document spécifie les exigences générales et les méthodes d'essai concernant les produits d'assistance pour personnes en situation de handicap, qui constituent également des dispositifs médicaux, et satisfont aux Exigences essentielles désignées en termes généraux dans l'Annexe 1 de la Directive UE 93/42/CEE, modifiée par la Directive 2007/47/CE. Il n'est nullement destiné à fournir un moyen de prouver la conformité vis-à-vis d'exigences d'une autre Directive.

NF EN ISO 16201
January 2007
Standard Cancelled
Technical aids for persons with disability - Environmental control systems for daily living

ISO 16201:2006 specifies functional and technical requirements and test methods for environmental control systems intended for use to alleviate or compensate for a disability. Such systems are also known as electronic aids to daily living. The aim of ISO 16201:2006 is to provide safety requirements and recommendations for manufacturers of such environmental control systems. Target devices are not covered by ISO 16201:2006. Technical requirements for items of equipment connected within the system are to be covered by their own specific standards, e.g. adjustable beds.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Matériaux
  • 6 Émissions sonores et vibrations
  • 7 Compatibilité électromagnétique
  • 8 Sécurité électrique
  • 9 Trop-plein, épanchement, fuite et pénétration de liquides
  • 10 Température des surfaces
  • 11 Stérilité
  • 12 Sécurité des parties mobiles
  • 13 Moyens de prévention des chutes
  • 14 Prévention des pièges pour certaines parties du corps humain
  • 15 Mécanismes de pliage et de verrouillage
  • 16 Poignées de portage
  • 17 Produits d'assistance qui soutiennent ou suspendent les utilisateurs
  • 18 Produits d'assistance mobiles et portables
  • 19 Surfaces, coins, bords et parties saillantes
  • 20 Produits d'assistance portatifs
  • 21 Produits d'assistance pour enfants
  • 22 Stabilité
  • 23 Forces sur les tissus mous du corps humain
  • 24 Principes ergonomiques
  • 25 Exigences relatives aux informations fournies par le fabricant
  • 26 Emballage
  • 27 Rapport d'essai
  • 28 Cadre directeur pour l'accessibilité des informations relatives aux produits d'assistance
  • Annexe A (informative) Recommandations générales
  • Annexe B (informative) Recommandations environnementales et recommandations relatives au consommateur
  • Annexe C (informative) Cadre directeur pour l'accessibilité des informations relatives aux produits d'assistance
  • Bibliographie
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