Standards ;

EN 13795-1 Surgical Clothing and Drapes – Requirements and Methods – Part 1: Surgical Drapes and
Gowns
EN 15223-1 Medical Devices – Symbols to be used with Medical Device Labels, Labelling and Information to
be supplied – Part 1: General Requirements
EN ISO 14791 Medical Devices – Application of Risk Management to Medical Devices
EN ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing