prEN 12182 rev

Assistive products for persons with disability - General requirements and test methods prEN 12182 rev

Scope

This European Standard specifies generaI requirements and test methods for assistive products for persons with disability which are intended by the manufacturer to be medical devices for the purposes of EU Directive 93/42/EEC concerning medical devices. This 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 specified in those 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 to specify aids which are not medical devices as defined in the EU Directive 93/42/EEC.

Related legislation

Legislation related to this standard