This document (EN 13795-2:2019) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany) with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-08 AA “Surgical textiles”. This standard contains specifications giving detail to the essential requirements set out in EC Directive 93/42/EEC on medical devices.
