ASTM_F_2103_-_11.pdf

Designation:F210311Standard Guide forCharacterization and Testing of Chitosan Salts as StartingMaterials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications1This standard is issued under the fixed designation F2103;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.INTRODUCTIONBiopolymers from marine sources have been studied and used in commercial applications andproduct development for a number of years.Chitosan,a linear polysaccharide consisting ofglucosamine and N-acetyl glucosamine derived mainly from crustacean shells,has been used in manytechnical applications such as water purification(as a flocculant),in cosmetics,and recently as aproposed fat-binding weight control product.In solution,the cationic nature of chitosan gives thispolymer a mucoadhesive property.Chitosan salts can be used as a matrix or scaffold material as wellas in non-parenteral delivery systems for challenging drugs.Chitosan salts have been shown toincrease the transport of polar drugs across the nasal epithelial surface.The purpose of this guide isto identify key parameters relevant for the functionality and characterization of chitosan salts for thedevelopment of new commercial applications of chitosan salts for the biomedical and pharmaceuticalindustries.1.Scope1.1 This guide covers the evaluation of chitosan saltssuitable for use in biomedical or pharmaceutical applications,or both,including,but not limited to,tissue-engineered medi-cal products(TEMPS).1.2 This guide addresses key parameters relevant for thefunctionality,characterization,and purity of chitosan salts.1.3 As with any material,some characteristics of chitosanmay be altered by processing techniques(such as molding,extrusion,machining,assembly,sterilization,and so forth)required for the production of a specific part or device.Therefore,properties of fabricated forms of this polymershould be evaluated using test methods that are appropriate toensure safety and efficacy.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 values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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 limitations 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 Plastics1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.42 on Biomaterials and Biomolecules for TEMPs.Current edition approved March 1,2011.Published March 2011.Originallyapproved in 2001.Last previous edition approved in 2007 as F2103 01(2007)2.DOI:10.1520/F2103-11.2For 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 F748 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 ofMaterials 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