ASTM F3089 - 14

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

    Active Standard ASTM F3089 | Developed by Subcommittee: F04.42

    Book of Standards Volume: 13.02

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    Significance and Use

    4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (a) collagen polymers as a starting material for surgical implants, substrates for tissue-engineered medical products (TEMPs), vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing; and (b) self-assembled collagen-based materials produced with collagen polymer formulations. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate collagen polymer starting material as well as associated self-assembled collagen-based products for a specific use. Not all tests or parameters are applicable to all uses of collagen.

    4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound and hemostatic dressings, surgical implants or injectables, hybrid medical devices, tissue-engineered medical products (TEMPs), injectable or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D in-vitro tissue systems or models for basic research, drug development, and toxicity testing. The practical application of the collagen polymers and associated self-assembled collagen-based materials should be based, among other factors, on biocompatibility, application-specific performance measures, as well as chemical, physical, and biological test data. Recommendations in this guide should not be interpreted as a guarantee of success for any research or medical application.

    4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of collagen polymer, impurities profile, and comprehensive chemical, physical, and biological characterization and testing.

    4.4 The following documents or other relevant guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of devices, biologics, drugs, and combination products should be considered when determining if the collagen supplied satisfies requirements for use in medical and research products, including TEMPs, therapeutic delivery vehicles, and 3D in-vitro tissue systems:

    FDA CFR:

    21 CFR 3: Product Jurisdiction:

    21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:


    FDA/CDRH CFR and Guidances:

    21 CFR Part 803: Medical Device Reporting:

    21 CFR 812: Investigational Device Exemptions:

    21 CFR 814: Premarket Approval of Medical Devices:

    21 CFR 820: Quality System Regulation:

    Design Control Guidance for Medical Device Manufacturers:

    Preproduction Quality Assurance Planning Recommendations for
     Medical Device Manufacturers (FDA 90-4236):

    The Review and Inspection of Premarket Approval Applications
     under the Bioresearch Monitoring Program—Draft Guidance
     for Industry and FDA Staff:

    FDA/CDRH Search Engines:

    CDRH Guidance Search Engine:

    CDRH Premarket Approval (PMA) Search Engine:

    CDRH 510(k) Search Engine:

    CDRH Recognized STANDARDS Search Engine:

    FDA/CBER CFR and Guidances:

    21 CFR 312: Investigational New Drug Application:

    21 CFR 314: Applications for FDA Approval to Market a New Drug:

    21 CFR 610: General Biological Products Standards:

    21 CFR 1271: Human Cells, Tissues and Cellular and Tissue-Based Products:

    Cellular & Gene Therapy Guidances and Other Publications:

    Human Tissue Guidances and Other Publications:

    CBER Product Approval Information:

    21 CFR 600, 601 BLA Regulations:

    21 CFR 210, 211 GMP Regulations:

    1. Scope

    1.1 This guide for characterizing polymerizable collagens is intended to provide characteristics, properties, test methods, and standardization approaches for use by producers, manufacturers, and researchers to identify specific collagen polymer formulations and associated self-assembled collagen-based products produced with these formulations. This guide will focus on the characterization of polymer forms of Type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant, and chemical synthesis. This guide is intended to focus on purified Type I collagen polymers as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. Polymerizable or self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components in the absence of the addition of exogenous factors including cross-linking agents. Self-assembling collagen polymers may include, but are not limited to: (1) tissue-derived atelocollagens, monomers, and oligomers; (2) collagen proteins and peptides produced using recombinant technology; and (3) chemically synthesized collagen mimetic peptides. It should be noted that the format of associated self-assembled collagen-based 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. This guide may serve as a template for characterization and standardization of other fibrillar collagen types that demonstrate polymerization or self-assembly.

    1.2 The ability of self-assembled collagen 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 (1, 2)2 and basic research studies (3, 4). The biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.

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

    1.4 Warning—Mercury has been designated by the Environmental Protection Agency (EPA) and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and the EPA website ( for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

    1.5 The following precautionary caveat pertains only to the test method portion, Section 5, 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 and health practices and determine the applicability of regulatory limitations prior to use.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products

    F619 Practice for Extraction of Medical Plastics

    F720 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

    F756 Practice for Assessment of Hemolytic Properties of Materials

    F763 Practice for Short-Term Screening of Implant Materials

    F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

    F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

    F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

    F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

    F1439 Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

    F1903 Practice for Testing For Biological Responses to Particles In Vitro

    F1904 Practice for Testing the Biological Responses to Particles in vivo

    F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity

    F1906 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation, and Cell Migration

    F1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications

    ISO Standards

    ISO 10993–10 Biological Evaluation of Medical Devices--Part 10: Tests for Irritation and Delayed-Type Hypersensitivity

    ISO 10993–17 Methods for Establishment of Allowable Limits for Leachable Substances Using Health-Based Risk Assessment

    ISO 10993–1 Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing with a Risk Management Process

    ISO 10993–3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity

    ISO 10993–9 Framework for Identification and Quantification of Potential Degradation Products

    ISO 13408–1 Aseptic Processing of Health Care Products--Part 1: General Requirements

    ISO 14971 Medical Devices--Application of Risk Management to Medical Devices

    ISO 22442–1 Animal Tissues and their Derivatives Utilized in the Manufacture of Medical Devices--Part 1: Analysis and Management of Risk

    ISO 22442–2 Animal Tissues and their Derivatives Utilized in the Manufacture of Medical Devices--Part 2: Controls on Sourcing, Collection, and Handling

    ISO 22442–3 Animal Tissues and their Derivatives Utilized in the Manufacture of Medical Devices--Part 3: Validation and the Elimination and/or Inactivation of Virus and Transmissable Agents

    U.S. and European Pharmacopeia Documents

    European Pharmacopeia 5.0

    United States Pharmacopeia (USP), Edition XXX (30)

    USP 30/NF 19 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

    ICH Documents

    ICH M3 Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals 62 FR 62922 (1997)

    ICH S1A Guideline for Industry S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals 61 FR 8153 (1996)

    ICH S1B Guidance for Industry S1B Testing for Carcinogenicity of Pharmaceuticals 63 FR 8983 (1998)

    ICH S1C Guideline for Industry S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals 60 FR 11278 (1995)

    ICH S2B Guidance for Industry S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals 62 FR 62472 (1997)

    ICH S5A Guideline for Industry S5A Detection of Toxicity to Reproduction for Medicinal Products 59 FR 48746 (1994)

    ICH S5B Guidance for Industry S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility 61 FR 15360 (1996)

    Code of Federal Regulations

    21 CFR 312 Investigational New Drug Application

    21 CFR Part 1271, Part C Suitability Determination for Donors of Human Cell and Tissue-based Products, Proposed Rule

    21 CFR Part 820 Quality System Regulation

    21 CFR Parts 207, 807, and 1271 Human Cells, Tissues and Cellular and Tissue-Based Products, Establishment Registration and Listing

    CFR 610.13(b) Rabbit Pyrogen Assay

    Current Good Tissue Practice for Manufacturers of Inspection and Enforcement. Proposed Rule. Federal Register/Vol. 66, No. 5/January 8, 2001/Proposed Rules, pp. 1552-1559

    Federal Register Vol. 43 No. 141, Friday, July 21, 1978

    Federal Register, Vol. 66 No. 13, Jan. 19, 2001/Rules and Regulations, p. 5447

    Federal Register, Vol. 72 No. 8, Jan. 12, 2007, pp. 1581-1619, Proposed Rule: Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

    Guidance for Industry and for FDA Reviewers Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), November 6, 1998, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health

    Guidance for Screening and Testing of Donors of Hu Availability. Federal Register/Vol. 62, No. 145/July 29, 1997/Notices Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents used in the Treatment of Urinary Incontinence. November 29, 1995. (ODE/DRARD/ULDB), Document No. 850

    ICS Code

    ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

    UNSPSC Code

    UNSPSC Code 12352202(Proteins)

    Referencing This Standard
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    DOI: 10.1520/F3089-14

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    Citation Format

    ASTM F3089-14, Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions, ASTM International, West Conshohocken, PA, 2014,

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