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ASTM F 3089 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
Available format(s)

Hardcopy , PDF

Superseded date

03-17-2023

Language(s)

English

Published date

07-10-2014

CONTAINED IN VOL. 13.02, 2014 Gives characteristics, properties, test methods, and standardization approaches for use by producers, manufacturers, and researchers to identify specific collagen polymer formulations and associated self-assembled collagenbased products produced with these formulations.

1.1This 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.

1.2The 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.

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

1.4Warning—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 (http://www.epa.gov/mercury/faq.htm) 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.

1.5The 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.

Committee
F 04
DocumentType
Guide
Pages
17
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 3510 : 2021 Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products

ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
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ASTM F 1983 : 1999 : R2008 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
AAMI TIR19 : 1998 GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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ASTM F 1983 : 2014 : REDLINE Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 1904 : 1998 : EDT 1 Standard Practice for Testing the Biological Responses to Particles In Vivo
ASTM F 763 : 2022 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
ASTM F 2148 : 2006 : REV A Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1903 : 2010 Standard Practice for Testing For Biological Responses to Particles <i>In Vitro</i>
ASTM F 763 : 2004 : R2016 Standard Practice for Short-Term Screening of Implant Materials
ASTM F 2148 : 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1439 : 2003 : R2008 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 1904 : 2014 Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>
ASTM F 1905 : 1998 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
ASTM F 2148 : 2007 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ASTM F 749 : 2013 : REDLINE Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
ASTM F 2148 : 2018 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1903 : 2010-07 PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ASTM F 2148 : 2007 : R2012 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 2148 : 2007 : EDT 1 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1439 : 2003 : R2018 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM E 1298 : 1989 : R2000 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
ASTM E 1298 : 1989 : R1994 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ASTM F 1904 : 1998 : R2008 Standard Practice for Testing the Biological Responses to Particles <i>in vivo</i>
ASTM F 2148 : 2001 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM E 1298 : 2006 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
ASTM F 1903 : 1998 Standard Practice for Testing for Biological Responses to Particles In Vitro
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CFR 21(PTS300-499) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 300-499
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ASTM F 763 : 1999 Standard Practice for Short-Term Screening of Implant Materials
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 1905 : 1998 : R2003 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
ASTM F 1439 : 2002 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 720 : 2017 : REDLINE Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ASTM F 1903 : 2018 Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph>
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ASTM F 1904 : 2014 : REDLINE Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ASTM F 1983 : 2014 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ISO 22442-3:2007 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 14971:2007 Medical devices Application of risk management to medical devices
ASTM F 1906 : 1998 : R2003 Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011)
ASTM F 1439 : 1992 : R1996 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
ASTM F 1439 : 2003 : R2013 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 1983 : 1999 Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications

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