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.