Standard Swedish standard · SS-EN 12182:2012

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

Status: Valid

Scope
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.

Subjects

Aids for disabled or handicapped persons (11.180) General (11.180.01) Aids and adaptation for moving (11.180.10) Aids for deaf and hearing impaired people (11.180.15) Aids for ostomy and incontinence (11.180.20) Aids and adaptations for reading (11.180.30) Aids for drinking and eating (11.180.40) Other standards related to aids for disabled and handicapped people (11.180.99)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-86282

Edition: 2

Approved: 5/11/2012

No of pages: 72

Replaces: SS-EN 12182