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ASTM-F2212:2007 Edition

ASTM-F2212:2007 Edition

$40.63

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)

Published By Publication Date Number of Pages
ASTM 2007 10
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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 nor for 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 (,) and laboratory studies (3,4,5,2.1) . Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the device manufacturer.

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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
3 Terminology
4 Significance and Use
Chemical and Physical Characterizations
5 Product Development Considerations
6 TABLE 1
7 Safety and Toxicology Aspects of Collagen
Keywords
8 X1. Background
X1.1 Background
X1.2 Overview/Introduction
X1.3 Collagen Classification
9 X1.4 Occurrences
X1.5 Sources
X1.6 Related Material
TABLE X1.1
10 REFERENCES

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