EN 12182:2012

Assistive products for persons with disability - General requirements and test methods

Publication date:   Jun 18, 2012

General information

99.60 Withdrawal effective   Jul 20, 2022

CEN

CEN/TC 293 Assistive products and accessibility

European Norm

11.180.01   Aids for disabled and handicapped persons in general

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Scope

This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC.
This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards.
NOTE Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN 12182:1999

NOW

WITHDRAWN
EN 12182:2012
99.60 Withdrawal effective
Jul 20, 2022

REVISED BY

PUBLISHED
EN ISO 21856:2022