SS-EN-12182 Assistive products for persons with disability - General requirements and test methods

SS-EN-12182 - 2012 EDITION - CURRENT
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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.

To find similar documents by classification:

11.180 (Aids for disabled or handicapped persons Including aids for elderly people)

11.180.01 (Aids for disabled and handicapped persons in general)

11.180.10 (Aids and adaptation for moving Including wheelchairs, walking sticks and lifting platforms)

11.180.15 (Aids for deaf and hearing impaired people)

11.180.20 (Aids for incontinence and ostomy)

11.180.30 (Aids for blind or partially sighted people Including Braille Glasses, contact lenses and their cleaning products, see 11.040.70)

11.180.40 (Aids for drinking and eating)

11.180.99 (Other standards related to aids for disabled and handicapped people)


Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

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Designation Name

SS-EN 12182:2012

Revision Level

2012 EDITION

Status

Current

Publication Date

May 11, 2012

Language(s)

English

Page Count

72

International Equivalent

EN 12182:2012(IDT)