ASTM F3089-23
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

Standard No.

ASTM F3089-23

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3089-23

Scope

1.1 This 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. 1.2 This 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. 1.2.1 This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissueengineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a 1 This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42 on Biomaterials and Biomolecules for TEMPs. Current edition approved Jan. 1, 2023. Published January 2023. Originally approved in 2014. Last previous edition approved in 2014 as F3089 – 14. DOI: 10.1520/F3089-23. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This 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. 1 device, biologic, drug, or combination product depending on its intended use and primary mode of action. 1.2.2 Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1) tissue-derived monomeric collagens, including tropocollagen or atelocollagen, and oligomeric collagens; (2) collagen proteins and peptides produced through in vitro cell culture, with or without using recombinant technology; and (3) chemically synthesized collagen mimetic peptides. It should be noted that the format of collagen polymeric material products also will vary and may include injectable solutions that polymerize in situ as well as preformed sheets, particles, spheres, fibers, sponges, matrices/gels, coatings, films, and other forms. 1.2.3 This guide may serve as a template for characterization and standardization of type I fibrillar collagen or other collagen types that demonstrate polymerization or selfassembly. 1.3 This 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. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 The 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. 1.6 This 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.

ASTM F3089-23 Referenced Document

• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM F1439 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
• ASTM F1903 Standard Practice for Testing for Biological Responses to Particles In Vitro
• ASTM F1904 Standard Practice for Testing the Biological Responses to Particles In Vivo
• ASTM F1983 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
• ASTM F2914 Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices*， 2024-01-15 Update
• ASTM F619 Standard Practice for Extraction of Medical Plastics
• ASTM F720 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F749 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
• ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F763 Standard Practice for Short-Term Screening of Implant Materials
• ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
• ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
• ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
• ISO 14971 Medical devices - Application of risk management to medical devices
• ISO 22442-1 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
• ISO 22442-2 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
• ISO 22442-3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
• ISO 5725-1 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions*， 2023-07-01 Update
• ISO 5725-2 Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
• ISO 5725-3 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate precision and alternative designs for collaborative studies*， 2023-06-01 Update
• ISO 5725-4 Accuracy (trueness and precision) of measurement methods and results — Part 4: Basic methods for the determination of the trueness of a standard measurement method
• ISO 5725-5 Accuracy (trueness and precision) of measurement methods and results - Part 5: Alternative methods for the determination of the precision of a standard measurement method; Technical Corrigendum 1
• ISO 5725-6 Accuracy (trueness and precision) of measurement methods and results - Part 6: Use in practice of accuracy values; Technical Corrigendum 1
• ISO/TR 22442-4 Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

ASTM F3089-23 history

• 2023 ASTM F3089-23 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
• 2014 ASTM F3089-14 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions