BS EN 12182:2012 - Assistive products for persons with disability. General requirements and test methods

BS EN 12182:2012

Assistive products for persons with disability. General requirements and test methods

Status : Current, Under review   Published : June 2012

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This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC. This European 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 considered in addition to those in 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 for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.




Standard NumberBS EN 12182:2012
TitleAssistive products for persons with disability. General requirements and test methods
StatusCurrent, Under review
Publication Date30 June 2012
Normative References(Required to achieve compliance to this standard)EN ISO 24415-1, EN 60730-1, EN ISO 13732-1, ISO 14155, EN ISO 13850, EN 556-1, ISO 12952-2, EN 61000-4-8, IEC 60601-1:2005, EN ISO 12952-1, IEC 61000-3-3, ISO 13850, EN 60601-1:2006, IEC 61000-3-2, IEC 80601-2-35, EN ISO 11135-1, EN 60950-1, ISO 25424, ISO 3746, EN 1041, EN 980, ISO 13732-1, EN 597-2, IEC 61000-4-8, EN 61000-3-2, EN 60065, EN ISO 11137-2, IEC 60529, ISO 22442-1, EN 61000-43, IEC 60065, EN 62304, IEC 62304, CISPR 11, EN ISO 11137-1, IEC 60730-1, IEC 60335-1, ISO 24415-1, EN ISO 14155, EN 60601-1-2:2007, EN 60529, ISO 24415-2, EN ISO 14971, ISO 10993-1, EN ISO 22442-1, ISO 14971, EN 60695-11-10, ISO 11135-1, ISO 12952-1, IEC 61000-4-3, IEC 60950-1, ISO 11137-1, EN ISO 25424, EN 61000-3-3, IEC 60695-11-10, ISO 11607-1, EN ISO 11607-1, EN 1021-2, EN 597-1, EN ISO 12952-2, EN 60335-1, EN 80601-2-35, ISO 11137-2, IEC 60601-1-2:2007, EN 614-1, EN ISO 10993-1, EN 1021-1, EN ISO 3746
Informative References(Provided for Information)IEC 60601-1-9:2007, 93/42/EEC, EN ISO 9227, MEDDEV 2.7.1, ISO 5349-1:2001, ISO 9227:2006, EN 60127-1, EN ISO 5349-2, EN ISO 5349-1, EN 60127-6, IEC 60127-4:2005, EN 717-1, IEC 60127-1:2006, EN 60068-2-32, EN ISO 9999, EN 894-3, 94/62/EC, IEC 60127-3:1988/AMD 1:1991, IEC 60127-3:1988/Corrigendum:1991, EN 60127-5, CEN/CENELEC Guide 6:2002, 67/548/EEC, EN 62079, IEC 60068-2-32:1975/AMD 2:1990, IEC 60068-2-32:1975, EN 120, IEC 62079:2001, EN 60127-3,

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