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CEN/TC 205

Non-active medical devices

European Committee

Sector operator: beMedTech
Belgian committee: beMedTech/E205

Standardization in the field of non-active medical devices with the objective to identify, adopt or adapt ISO or other standards, or if no ISO or other standard exists, to prepare CEN standards supporting applicable European regulations for non-active medical devices. Excluded are non-active medical devices currently within the scopes of other CEN/TCs, but included are (with appropriate liaison with CENELEC) some types of non-active medical devices that use electrical power (from battery or mains supply) for functioning. The excluded areas are, for example, dentistry, sterilizers for medical purposes, in-vitro diagnostic medical devices, sterilization of medical devices, biological evaluation of medical devices, respiratory anaesthetic equipment, chemical desinfectants and antiseptics, clinical investigation of medical devices, non-active surgical implants, assistive products for persons with disability.

Sector Operator: BeMedTech
So Address Line1: Chaussée Romaine 468
So Address Line2: BE-1853 Strombeek-Bever
Contact: contact info@bemedtech.be

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