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BS EN 12182:1999 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. Other European Standards exist for particular types of technical aids. However, some of the requirements of this standard may still apply and may be specified in other European Standards.
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