Report of ISO/TC 150 (Implants for Surgery)-Relationship between Regulation and Standards-

Abstract

The most typical international standardization organizations for medical devices might be International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM International). The author is responsible to report the activities of ISO/TC 150 (Implants for Surgery) in asking the supports and understanding for the relationship between standards and regulation, as Chairman of the Japanese Committee for ISO/TC 150.There are six working groups (WG) under TC 150, and seven sub-committees (SC). Among them, WG 14 (Models of tissues for mechanical testing of implants) and SC 7 (Tissue engineered medical products) were established by Japanese proposal and the chairman and secretariat of them were selected from Japan.One of the recent movements is continuous discussions to seek directions determine the standard values so as to be the minimum safety requirements for the regulation.