Name: Assistive products for persons with disability - General requirements and test methods
Identifier: EN 12182:2012
Issuing Organisation: CEN
Organization website (opens in new window): http://standards.cen.eu/
Link to standard (opens in new window): http://standards.cen.eu/dyn/www/f?p=204%3A110%3A0%3A%3A%3A%3AFSP_PROJECT%2CFSP_ORG_ID%3A30940%2C6274&cs=1B76CECC295901B4E65BFF887A20CA7F0
Issue Year: 2012
Forward Review Date: Not known
Intended Audiences: Carers, Governmental and Public Sector Bodies, Older People, and Private Sector Bodies
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.
Relevance to Active and Healthy Ageing: High
Older Person Specific: No
Usage / Adoption status: Not known
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
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