ASTM_F_3225_-_17.pdf

Designation:F322517Standard Guide forCharacterization and Assessment of Vascular Graft TissueEngineered Medical Products(TEMPs)1This standard is issued under the fixed designation F3225;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.1.Scope1.1 This guide is intended as a resource for individuals andorganizations involved in the development,production,delivery,and regulation of tissue engineered medical products(TEMPs)intended for use in the surgical repair,replacement,shunting and/or bypass of blood vessels.This guide is intendedfor use related to the in vitro assessment of TEMP vasculargrafts.In vitro cellular characterization and in vivo testing arenot within scope for this standard guide.1.2 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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2F1635 Test Method forin vitro Degradation Testing ofHydrolytically Degradable Polymer Resins and FabricatedForms for Surgical ImplantsF2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-uctsF2210 Guide for Processing Cells,Tissues,and Organs forUse in Tissue Engineered Medical Products(Withdrawn2015)3F2211 Classification for Tissue Engineered Medical Prod-ucts(TEMPs)F2212 Guide for Characterization of Type I Collagen asStarting Material for Surgical Implants and Substrates forTissue Engineered Medical Products(TEMPs)F2312 Terminology Relating to Tissue Engineered MedicalProductsF2382 Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Throm-boplastin Time(PTT)F2739 Guide for Quantifying Cell Viability within Bioma-terial ScaffoldsSTP 997-EB Compositional Analysis by Thermogravimetry2.2 US FDA Regulations and Guidance Documents:421 CFR 610.12 General Biological Products StandardsSterility21 CFR 1270 Human Tissue Intended for Transplantation21 CFR 1271 Human Cells,Tissues,and Cellular andTissue-Based ProductsFDA Guidance for Industry:Pyrogen and Endotoxins Test-ing:Questions and AnswersGuidance for Industry:Eligibility Determination for Donorsof Human Cells,Tissues,and Cellular and Tissue-BasedProducts(HCT/Ps)FDA Guidance for Industry:Container and Closure SystemIntegrity Testing in Lieu of Sterility Testing as a Compo-nent of the Stability Protocol for Sterile ProductsGuidance for Industry and Food and Drug AdministrationStaff:Use of International Standard ISO-10993-1,Bio-logical Evaluation of Medical DevicesPart 1:Evalua-tion and testing within a risk management process2.3 ISO Standards:5ISO 7198 Cardiovascular implants and extracorporealsystemsVascular prosthesesTubular vascular graftsand vascular patchesISO 10993 Biological evaluation of medical devices1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.44 on Assessment for TEMPs.Current edition approved Nov.15,2017.Published December 2017.DOI:10.1520/F322517.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from U.S.Government Printing Office,Superintendent ofDocuments,732 N.Capitol St.,NW,Washington,DC 20401-0001,http:/www.access.gpo.gov.5Available from International Organization for Standardization(ISO),ISOCentral Secretariat,BIBC II,Chemin de Blandonnet 8,CP 401,1214 Vernier,Geneva,Switzerland,http:/www.iso.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 ISO 11135 Sterilization of health-care productsEthyleneoxideRequirements for the development,validation androutine control of a sterilization process for medicaldevicesISO 11137(P