Journal of the Japanese Association of Regenerative Dentistry
J Jpn Assoc Regenerative Dent Vol.6(2) pp.82-89
Trends of International and Japanese Standardization for Tissue Engineered Medical and Dental Products
Sadami TSUTSUMI1, Koichi IMAI2
1Nihon University Dental School
2Department of Biomaterials, Osaka Dental University
Most of the standards for the tissue engineered medical products should be fundamentally different in their characteristics from the conventional de facto standards which have been based on the market perception and/or interchangeability, but be de jure standards which are the constitutional rules or guidelines in order to establish new preferable medical products.
Recently, the ISO/TC150/SC7 (International Organization for Standards/ Technical Committee 150 for Surgical Implants/ Sub Committee 7 for Tissue Engineered Medical Products) has been set up in 2007 that was proposed and organized by Japan as international secretariat. In harmonization with the international activities in ISO/TC150/SC7, ISO/TC194/SC1 and ASTM/F04 the Japanese standardization trends have been accelerated rapidly in these years.
Keyword: International standards, Tissue engineered medical products, ISO/TC150/SC7, ASTM, JIS