ASTM_F_2347_-_11.pdf

Designation:F234711Standard Guide forCharacterization and Testing of Hyaluronan as StartingMaterials Intended for Use in Biomedical and TissueEngineered Medical Product Applications1This standard is issued under the fixed designation F2347;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.INTRODUCTIONHyaluronan,which in this guide will encompass hyaluronic acid,hyaluronate,and its salt forms,isthe simplest of the glycosaminoglycans.Hyaluronan is soluble in water and forms highly viscoussolutions.Hyaluronan is found in ubiquitously in the body as part of the extracellular matrix of tissues,with high concentrations in the synovial fluid,vitreous humor,and skin,as well as in cartilage.Hyaluronan has found uses in a variety of products ranging from viscosupplements(treatment ofosteoarthritis),adhesion prevention(prevention of post-surgical adhesions),viscoelastics(ocularprotection),and dermal implants(lip augmentation and wrinkle removal).New applications,such asscaffolds for tissue engineering,are emerging.The aim of this guide is to identify key parametersrelevant to the characterization of hyaluronan for the development of new commercial applications ofhyaluronan for the biomedical and pharmaceutical industries.1.Scope1.1 This guide covers the evaluation of hyaluronan suitablefor use in biomedical or pharmaceutical applications,or both,including,but not limited to,Tissue Engineered MedicalProducts(TEMPs).1.2 This guide addresses key parameters relevant to thecharacterization and purity of hyaluronan.1.3 As with any material,some characteristics of hyaluro-nan may be altered by processing techniques,such as cross-linking and sterilization,required for the production of aspecific formulation or device.Therefore,properties of fabri-cated forms of this polymer should be evaluated using testmethods that are appropriate to ensure safety and efficacy andare not addressed in this guide.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory requirements prior to use.2.Referenced Documents2.1 ASTM Standards:2D2196 Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational(Brookfield type)ViscometerF619 Practice for Extraction of Medical PlasticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF749 Practice for Evaluating Material Extracts by Intracuta-neous Injection in the RabbitF756 Practice for Assessment of Hemolytic Properties ofMaterialsF763 Practice for Short-Term Screening of Implant Materi-alsF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect of1This 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 March 1,2011.Published March 2011.Originallyapproved in 2003.Last previous edition approved in 2003 as F2347 03.DOI:10.1520/F2347-11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Materials on Muscle and BoneF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices(Withdrawn 2012)3F1439 Guide for Performance of Lifetime Bioassay for theTumorigenic Potential of Implant MaterialsF1903 Practice for Testing For Biological Responses toParticles In VitroF1904 Practice for Testing the Biological Responses toParticles in vivoF1905 Practice For Selecting Tests for Determining thePropensity of Materials to Cause Immunotoxicity(With-drawn 2011)3F1906 Practice for Evaluation of Immune Responses InBiocompatibility Testing Using ELISATests,LymphocyteProliferation,and Cell Migration(Withdrawn 2011)32.2 USP Documents:4USP Microbial Limit TestsUSP Sterility TestsUSP Bacterial Endotoxins TestsUSP Heavy MetalsUSP Loss on DryingUSP Sterilization and Sterility Assurance of Com-pendial Articles2.3 EP Documents:5EP Monograph 1472 Sodium HyaluronateEP 2.6.1 Sterility2.4 Other Referenced Documents:ISO 10993 Biological Evaluatio