1、Designation:F290011Standard Guide forCharacterization of Hydrogels used in RegenerativeMedicine1This standard is issued under the fixed designation F2900;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A num
2、ber in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 Hydrogels are water-swollen polymeric networks thatretain water within the spaces between the macromolecules;and maintain the structural integ
3、rity of a solid due to thepresence of cross-links(1-3).2They are mainly used inregenerative medicine as matrix substitutes,delivery vehiclesfor drugs and/or biologics,and environments for cell culture.Inthese applications,hydrogel efficacy may depend on the abilityto:support the permeation of dissol
4、ved gases,nutrients andbioactive materials;sustain cell growth and migration;de-grade;release drugs and/or biologics at an appropriate rate;andmaintain their shape.1.2 Hydrogels used in regenerative medicine can be com-posed of naturally derived polymers(for example,alginate,chitosan,collagen(4,5),s
5、ynthetically derived polymers(forexample,polyethylene glycol(PEG),polyvinyl alcohol(PVA)(4,5)or a combination of both(for example,PVA withchitosan or gelatin(6).In clinical use,they can be injected orimplanted into the body with or without the addition of drugsand/or biologics(7).1.3 This guide prov
6、ides an overview of test methods suit-able for characterizing hydrogels used in regenerative medi-cine.Specifically,this guide describes methods to assesshydrogel biological properties,kinetics of formation,degrada-tion and agent release,physical and chemical stability andmass transport capabilities
7、 are discussed.1.4 The test methods described use hydrated samples withone exception:determining the water content of hydrogelsrequires samples to be dried.It is generally recommended thathydrogels that have been dried for this purpose are notrehydrated for further testing.This recommendation is due
8、 tothe high probability that,for most hydrogel systems,thedrying-rehydration process can be detrimental with possiblealterations in structure.1.5 This guide does not consider evaluation of the micro-structure of hydrogels(for example,matrix morphology,mac-romolecule network structure and chain confo
9、rmation).1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 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
10、 appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3D4516 Practice for Standardizing Reverse Osmosis Perfor-mance DataF748 Practice for Selecting Generic Biological Test Methodsfor Materials and D
11、evicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF2027 Guide for Characterization and Testing of Raw orStarting Biomaterials for Tissue-Engineered MedicalProductsF2064 Guide for Characterization and Testing of Alginatesas Starting Materials Intended for Use in Biomedica
12、l andTissue Engineered Medical Product ApplicationsF2103 Guide for Characterization and Testing of ChitosanSalts as Starting Materials Intended for Use in Biomedicaland Tissue-Engineered Medical Product ApplicationsF2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue
13、-Engineered Medical Prod-uctsF2214 Test Method forIn Situ Determination of NetworkParameters of Crosslinked Ultra High Molecular WeightPolyethylene(UHMWPE)F2315 Guide for Immobilization or Encapsulation of LivingCells or Tissue in Alginate Gels1This guide is under the jurisdiction of ASTM Committee
14、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 15,2011.Published March 2011.DOI:10.1520/F290011.2The boldface numbers in parentheses refer to a list of references at the
15、 end ofthis standard.3For 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
16、Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F2347 Guide for Characterization and Testing of Hyaluro-nan as Starting Materials Intended for Use in Biomedicaland Tissue Engineered Medical Product ApplicationsF2383 Guide for Assessment of Adventitious Agents inTissue Engineered Medical Products(TEMPs)F2450 Guide for Assessing Microstructure of PolymericScaffolds for Use in Tissue-Engineered Medical ProductsF2739 Guide for Quantitating Cell Viability Within Bioma-terial Scaffold
