INTRODUCTION TO ASTM BIOMATERIALS MEDICAL PRODUCT STANDARDS

摘要

Biomaterials have become an important part of the medical world, and in response the ASTM International Committee F04 on Medical and Surgical Materials and Devices has taken on the task of developing technical standards in this important area. Formed in 1962, ASTM Committee F04 develops standards and guidance for medical and surgical materials and devices. There are a number of subcommittees throughout Committee F04 related to biomaterials; such as the P04.13 ceramics subcommittee, the P04.12 metals subcommittee and the P04.11 polymers subcommittee. However, most of the focus on biomaterials can be found within two of its subcommittees. Subcommittee F04.42 on biomaterials and biomolecules for tissue engineered medical products (TEMPs) develops standards that "identify the normal biological functional characteristics that would be required of a tissue-engineered medical product." Key standards include ASTM F2150 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products; ASTM F2900 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine; and ASTM F2027 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products.