ASTM International, formerly known as the American Society for Testing and Materials (ASTM), West Conshohocken, PA, has proposed a new international standard to be used in the design, development, quality control, and comparison of a variety of collagen-based medical products, including surgical implants, delivery vehicles for therapeutic cells or molecules, and substrates for tissue engineered medical products. ASTM WK43011, Specification for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions, is currently being developed by the ASTM International Committee F04 on Medical and Surgical Materials and Devices.
In addition to product development, the proposed standard will be valuable as a research tool, and will facilitate improving quality control processes in tissue engineering product development.
ASTM WK43011 will address issues related to production, characterization, and functional testing of polymerizable collagens for research and clinical applications, as well as product development and quality control. Collagens exhibiting polymerization or self-assembly are currently further categorized as tissue-derived (atelocollagen, gelatin, monomer, and oligomer), recombinant (collagen proteins and peptides) and chemically synthesized (collagen mimetic peptides).
Once it has been approved, the proposed standard will be used primarily by laboratories and commercial entities that manufacture and use collagen for development of research and medical products. Regulatory bodies may also consider ASTM WK43011 for comparing the composition, functional properties, and safety of collagen-based products.
