Artecoll is produced in modern clean-room facilities, class 10-100 (US.Fed.Std.209e). The highest possible safety of product manufacturing is assured under internationally accepted standards. The production process is under strict control by the Ministry of Health of The Netherlands and the Dutch Notified Body N.V. KEMA. Artecoll holds the Quality System Certificate Nr. 51490, of the Notified Body NV KEMA, member of EQ Net, the International Certification Network, meeting the requirements of the standards ISO9002, EN46002. Artecoll has the CE mark (Council Directive 93/42 EEC of 14th June 1993), NR 51490TE01, according to the EC Type Examination Medical Devices Class III.