EN 12182:1999

EN 12182:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Technical aids for disabled persons - General requirements and test methods". This standard covers: This European Standard specifies generaI 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.

This European Standard specifies generaI 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.

EN 12182:1999 is classified under the following ICS (International Classification for Standards) categories: 11.180 - Aids for disabled or handicapped persons. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 12182:1999 has the following relationships with other standards: It is inter standard links to EN 12182:2012, EN 1985:1998, EN ISO 11199-3:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 12182:1999 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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