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DIN Standards Committee Health Technologies

Overview

This standard has been prepared by Technical Committee CEN/TC 293 "Assistive products for persons with a disability" of the European Committee for Standardization (CEN) with the participation of German experts from Mirror Committee NA 063-01-06 AA "Rollstühle" ("Wheelchairs"). There are three levels of European Standards dealing with assistive products for persons with a disability. These are as follows, with Level 1 being the highest: Level 1: General requirements for assistive products; Level 2: Particular requirements for families of assistive products; Level 3: Specific requirements for types of assistive products. All European Standards produced or currently being developed by CEN/TC 293 are listed in Annex A. This standard is a Level 1 standard and contains requirements and recommendations which are generally applicable to assistive products for persons with a disability. For certain types of assistive products, these requirements are to be supplemented, modified or replaced by the special requirements of a standard for a particular assistive product (Level 2 or 3). The Level 2 standards apply to a more restricted set or family of assistive products such as assistive products for walking. The Level 3 standards apply to specific types of assistive products, for example, elbow crutches and urine collection bags. Where standards for particular assistive products or groups of assistive products exist (Level 2 or 3), this general standard should not be used alone. The requirements of lower level standards take precedence over higher level standards. Therefore, to address all requirements for a particular assistive product, it is necessary to start with standards of the lowest available level. European and International Standards for other assistive products for persons with a disability are being or may be developed by other technical committees within CEN/CENELEC, ISO/IEC (for example, assistive products for hearing) and other organisations. For such assistive products, this Level 1 standard is only applicable if explicitly cited as a normative reference in the particular standard, although it may be used for general guidance within the field of assistive products for persons with a disability. Special care is required in applying this general standard to assistive products for which no particular standard exists to ensure that all aspects of safety are covered in the particular circumstances of the use of those assistive products. Guidance is given on aspects of the Essential Requirements of EU Directive 93/42/EEC to assist in this process. The use of assistive products may involve undesirable side effects and it is necessary to establish a balance between achieving the desired end result and the risk of such side effects. Hence, in exceptional circumstances, provision is made within this standard for clinical needs to override the requirements of this standard so long as adequate warnings are given. This standard calls for technical documentation to be prepared which may be used by manufacturers as part of the technical documentation required by EU Directive 93/42/EEC. Where DIN EN 12182 does not fully apply to particular assistive products, contracting parties should consider if appropriate parts of the standard can be used.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-06-06 AA - Wheelchairs  

Responsible european committee

CEN/TC 293/WG 10 - Revision of EN 12182