ASTM F2212-02

ASTM F2212-02 - 10.11.2002

1. 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 standard 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 guideline 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 document 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 nor for tissue implants. This document 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) and laboratory studies (3,4,5,21). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the device manufacturer.

1.3 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 requirements prior to use.

2. Referenced Documents

E1298-06	Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
F720-17	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
European Pharmacopeia 5.0
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
F1903-18	Standard Practice for Testing for Cellular Responses to Particles in vitro
F1904-23	Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
F1905-98	Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F1906-98	Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
F1983-23	Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
F2148-18	Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
F1439-03(2018)	Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F1251-89(1995)	Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices