ASTM F 2212 : 2002 : R2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
Hardcopy , PDF
11-11-2014
English
01-02-2007
Committee |
F 04
|
DocumentType |
Guide
|
Pages |
10
|
ProductNote |
Reconfirmed 2007
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
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
ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
ASTM F 2903 : 2011 | Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
ASTM F 3223 : 2017 | Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction |
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