Collagen Analysis
Designation: F 2212 – 08e1
Standard Guide for
Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)1
This standard is issued under the fixed designation F 2212; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e1 NOTE—Mercury warning was editorially added in April 2008.
INTRODUCTION
Collagen-based medical products are becoming more prevalent, especially in the area of soft tissue augmentation. The use of collagen in surgery dates back to the late 1800s, with the use of catgut sutures, human cadaveric skin, and fascia. More recently, collagen has been used in hemostatic sponges, dermal equivalents, injectables for soft tissue augmentation, as a matrix for cell-based products and as a vehicle for drug delivery. It is because of the versatility of collagen in medical applications that specific characterizations should be performed as a way to compare materials. 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 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
Standard Guide for
Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)1
This standard is issued under the fixed designation F 2212; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e1 NOTE—Mercury warning was editorially added in April 2008.
INTRODUCTION
Collagen-based medical products are becoming more prevalent, especially in the area of soft tissue augmentation. The use of collagen in surgery dates back to the late 1800s, with the use of catgut sutures, human cadaveric skin, and fascia. More recently, collagen has been used in hemostatic sponges, dermal equivalents, injectables for soft tissue augmentation, as a matrix for cell-based products and as a vehicle for drug delivery. It is because of the versatility of collagen in medical applications that specific characterizations should be performed as a way to compare materials. 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 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