CEN/CLC/TC 3 is the standard used for quality management and other general aspects for medical devices .
This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.CEN/CLC/TC 3 Quality management and corresponding general aspects for medical devices -- European Community for Electrotechnical Standardization
ISO 13485