SR EN 12182:2003

Technical aids for disabled persons - General requirements and test methods

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.

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General information

Status : Withdrawn
Approval date : 9/24/2003
Publish date : 9/25/2003
Withdrawal date : 10/31/2012
Number of pages : 36
ICS : 11.180.01 Aids for disabled and handicapped persons in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN 868-1:2003
Normative reference SR EN 61000-4-3:2003
Normative reference SR EN 61000-3-2:2001
Normative reference SR EN 61000-3-3:1998
Normative reference SR EN 60335-1:1999
Normative reference SR EN 60601-1+A1+A2+A13:2001
Normative reference SR EN 60601-1-2:2001
Normative reference SR EN 60601-1-4:2002
Normative reference SR EN 614-1:1997
Normative reference SR EN 597-1:1998
Normative reference SR EN ISO 10993-1:2004
Normative reference SR EN 552:2001
Normative reference SR EN 1041:2003
Normative reference SR EN ISO 12952-3:2003
Normative reference SR EN ISO 9999:2002
Normative reference SR EN 418:1996
Normative reference SR EN 597-2:1998
Normative reference SR EN 12442-1:2002
Normative reference SR EN 550:1997
Normative reference SR EN 563+AC:2001
Normative reference SR EN ISO 12952-2:2003
Normative reference SR EN 554:2003
Normative reference SR EN ISO 12952-4:2003
Normative reference SR EN 1021-1:1997
Normative reference SR EN 1021-2:1997
Normative reference SR EN ISO 12952-1:2003
Normative reference SR EN 556-1:2003
Replaced by SR EN 12182:2012