ASTM F2212-19
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

Standard No.

ASTM F2212-19

Release Date

2019

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2212-20

Latest

ASTM F2212-20

Scope

1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen. 1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3, 4, 5, 6). 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 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 EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercurycontaining 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 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 Sept. 1, 2019. Published December 2019. Originally approved in 2002. Last previous edition approved in 2011 as F2212 – 11 . DOI: 10.1520/F2212-19. 2 The boldface numbers in parentheses refer to the list of references at the end of this standard. 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 Copyright ASTM International 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 F2212-19 Referenced Document

• 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 F2148 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
• 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 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update

ASTM F2212-19 history

• 2020 ASTM F2212-20 Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2019 ASTM F2212-19 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2011 ASTM F2212-11 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2009 ASTM F2212-09 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2008 ASTM F2212-08e1 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2008 ASTM F2212-08 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2002 ASTM F2212-02(2007)e1 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2002 ASTM F2212-02(2007) Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• 2002 ASTM F2212-02 Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)