EN 12182:2012

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Emitted sound and vibration
7 Electromagnetic compatibility
8 Electrical safety
9 Overflow, spillage, leakage, and ingress of liquids
10 Surface temperature
11 Sterility
12 Safety of moving parts
13 Prevention of traps for parts of the human body
14 Folding and adjusting mechanisms
15 Carrying handles
16 Assistive products which support or suspend users
17 Portable and mobile assistive products
18 Surfaces, corners, edges and protruding parts
19 Hand held assistive products
20 Small parts
21 Stability
22 Forces in soft tissues of the human body
23 Ergonomic principles
24 Requirements for information supplied by the manufacturer
25 Packaging
26 Test report
Annex A (informative) - European standards for assistive
        products for persons with a disability produced or
        currently being developed by CEN/TC 293
Annex B (informative) - General recommendations
Annex C (informative) - Cognitive impairment
Annex D (informative) - Environmental and consumer related
        requirements
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Bibliography

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. NOTENot 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.