ASTM_F_2212_-_11.pdf

Designation:F221211Standard Guide forCharacterization of Type I Collagen as Starting Material forSurgical Implants and Substrates for Tissue EngineeredMedical Products(TEMPs)1This standard is issued under the fixed designation F2212;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONCollagen-based medical products are becoming more prevalent,especially in the area of soft tissueaugmentation.The use of collagen in surgery dates back to the late 1800s,with the use of catgutsutures,human cadaveric skin,and fascia.More recently,collagen has been used in hemostaticsponges,dermal equivalents,injectables for soft tissue augmentation,as a matrix for cell-basedproducts and as a vehicle for drug delivery.It is because of the versatility of collagen in medicalapplications that specific characterizations should be performed as a way to compare materials.1.Scope1.1 This guide for characterizing collagen-containing bio-materials is intended to provide characteristics,properties,andtest methods for use by producers,manufacturers,and re-searchers to more clearly identify the specific collagen mate-rials used.With greater than 20 types of collagen and thedifferent properties of each,a single document would becumbersome.This guide will focus on the characterization ofType I collagen,which is the most abundant collagen inmammals,especially in skin and bone.Collagen isolated fromthese sources may contain other types of collagen,for example,Type III and Type V.This guide does not provide specificparameters for any collagen product or mix of products or theacceptability of those products for the intended use.Thecollagen may be from any source,including,but not limited to,animal or cadaveric sources,human cell culture,or recombi-nant sources.The biological,immunological,or toxicologicalproperties of the collagen may vary,depending on the sourcematerial.The properties of the collagen prepared from each ofthe above sources must be thoroughly investigated,as thechanges in the collagen properties as a function of sourcematerials is not thoroughly understood.This guide is intendedto focus on purified Type I collagen as a starting material forsurgical implants and substrates for tissue engineered medicalproducts(TEMPs);some methods may not be applicable forgelatin or tissue implants.This guide may serve as a templatefor characterization of other types of collagen.1.2 The biological response to collagen in soft tissue hasbeen well documented by a history of clinical use(1,2)2andlaboratory studies(3,4,5,6).Biocompatibility and appropri-ateness of use for a specific application(s)is the responsibilityof the product manufacturer.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 WarningMercury has been designated by EPA andmany state agencies as a hazardous material that can causecentral nervous system,kidney,and liver damage.Mercury,orits vapor,may be hazardous to health and corrosive tomaterials.Caution should be taken when handling mercury andmercury-containing products.See the applicable product Ma-terial Safety Data Sheet(MSDS)for details and EPAs website(http:/www.epa.gov/mercury/faq.htm)for additional informa-tion.Users should be aware that selling mercury or mercury-containing products,or both,in your state may be prohibited bystate law.1.5 The following precautionary caveat pertains only to thetest method portion,Section 5,of this guide.This standarddoes not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the user of thisstandard to establish appropriate safety and health practicesand determine the applicability of regulatory requirementsprior to use.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved April 1,2011.Published May 2011.Originallyapproved in 2002.Last previous edition approved in 2009 as F2212 09.DOI:10.1520/F2212-11.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.Referenced Documents2.1 ASTM Standards:3E1298 Guide for Determination of Purity,Impurities,andContaminants in Biological Drug ProductsF619 Practice for Extraction of Medical PlasticsF720 Practice for Testing Guinea Pigs for ContactAllergens:Guinea Pig Maximization TestF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF749 Practice for Evaluating Material Extracts by Intracuta-neous Injection in the RabbitF756 Practic