ASTM_F_2064_-_14.pdf

Designation:F206414Standard Guide forCharacterization and Testing of Alginates as StartingMaterials Intended for Use in Biomedical and TissueEngineered Medical Product Applications1This standard is issued under the fixed designation F2064;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.INTRODUCTIONAlginate has found uses in a variety of products ranging from simple technical applications such asviscosifiers to advanced biomedical matrices providing controlled drug delivery from immobilizedliving cells.As for most hydrocolloids,the functionality of alginate is related to its chemical andstructural composition.The aim of this guide is to identify key parameters relevant for thefunctionality and characterization of alginates for the development of new commercial applications ofalginates for the biomedical and pharmaceutical industries.1.Scope1.1 This guide covers the evaluation of alginates suitable foruse in biomedical or pharmaceutical applications,or both,including,but not limited to,Tissue Engineered MedicalProducts(TEMPs).1.2 This guide addresses key parameters relevant for thefunctionality,characterization,and purity of alginates.1.3 As with any material,some characteristics of alginatesmay 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 and are not addressed in this guide.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 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 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 ofMaterials on Muscle and Bone1This 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 Oct.1,2014.Published February 2015.Originallyapproved in 2000.Last previous edition approved in 2000 as F2064 00(2006)1.DOI:10.1520/F2064-14.2For 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 F1251 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)3F2259 Test Method for Determining the Chemical Compo-sition and Sequence in Alginate by Proton Nuclear Mag-netic Resonance(1H NMR)SpectroscopyF2315 Guide for Immobilization or Encapsulation of LivingCells or