ÖNORM EN 12182

This European Standard specifies general requirements and test methods for technical aids for disabled persons 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 technical aids which achieve their intended purpose by administering pharmaceutical substances to the user. Where other European Standards exist for particular types of technical aids 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 9999:1998 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.