Biomaterials Subcommittee Currently at Work on Proposed Mineral Based Scaffold Standard
Technical advancements in both tissue engineering and bone substitute materials have resulted in a great increase in the number of tissue-engineered medical products available on the market. Many of these new products are mineral-based, often using calcium phosphate scaffolds.
While there are some general standards on scaffolds in tissue-engineered medical products, a comprehensive standard on mineral and ceramic scaffolds has not yet been developed. ASTM International Committee F04 on Medical and Surgical Materials and Devices is now working on such a proposed standard, WK15152, Guide for Characterization of Ceramic and Mineral Based Scaffolds Used for Tissue-Engineered Medical Products (TEMPs) and as Medical Devices for Surgical Implant Applications. The proposed new standard is under the joint jurisdiction of Subcommittee F04.42 on Biomaterials and Biomolecules for TEMPs and Subcommittee F04.13 on Ceramic Materials.
“The proposed standard will be a guideline that describes the most important characterization requirements of the chemical, physical, biological and mechanical nature of scaffolds used in tissue-engineered products or as implants,” says Reto Luginbuehl, an F04.42 and F04.13 member who is responsible for chemical, biochemical and tissue engineering issues at the Dr. h.c. Robert Mathys Foundation in Bettlach, Switzerland. “We hope that this proposed standard will develop into a common tool for the medical device industry. It should ease the filing for new products with a notified body and it might also facilitate the comparison of such products for professionals.”
Interested parties are invited to participate in the standards developing activities of Subcommittee F04.42 and F04.13, including work on WK15152. //
Technical Information: Reto Luginbuehl, Dr. h.c. Robert Mathys Foundation, Bettlach, Switzerland
ASTM Staff: Daniel Schultz
November Committee Week