ASTM F 3089 : 2023

1.1This guide is intended to provide characteristics, properties, test methods, and standardization approaches for evaluation and identification of specific polymerizable collagen formulations and collagen polymeric materials produced with these formulations.

1.2This guide focuses on characterization of purified polymerizable forms of type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant cell culture, and chemical synthesis.

1.3This guide does not provide a significant basis for assessing the biological safety (biocompatibility) of polymerizable collagens and collagen polymeric materials. While the ability of collagen polymeric materials to guide cellular responses through provision of cellular adhesion and proteolytic domains as well as physical constraints (for example, structural, cell-matrix traction force) has been well documented through extensive clinical and basic research studies (1-5),2 users are directed to the ISO 10993 series for evaluating biological risks of medical devices. The biocompatibility and appropriateness of use for a specific application is the responsibility of the product manufacturer.

1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5The following precautionary caveat pertains only to the test method portion, Sections 6 and 7, of this guide: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.