NF EN ISO 16201
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.
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.
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.
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions1
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4 Exigences générales3
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4.1 Évaluation des risques3
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4.2 Informations fournies par le fabricant3
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4.3 Matériaux4
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5 Exigences et méthodes d'essai fonctionnelles4
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5.1 Généralités4
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5.2 Conception5
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5.3 Interface utilisateur5
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5.4 Fonctions contrôlées7
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6 Exigences de sécurité et méthodes d'essai techniques10
- Annexe A (informative) Notes d'orientation11
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