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.
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 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 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 Feb. 1, 2008. Published March 2008. Originally approved in 2002. Last previous edition approved in 2007 as F 2212 – 02 (2007) e1.
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 (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 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...