ASTM_F_2211_-_13.pdf

Designation:F221113Standard Classification forTissue Engineered Medical Products(TEMPs)1This standard is issued under the fixed designation F2211;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 classification outlines the aspects of tissue engi-neered medical products that will be developed as standards.This classification excludes traditional transplantation of or-gans and tissues as well as transplantation of living cells aloneas cellular therapies.1.2 This classification does not apply to any medical prod-ucts of human origin regulated by the U.S.Food and DrugAdministration under 21 CFR Parts 16 and 1270 and 21 CFRParts 207,807,and 1271.1.3 This standard does not purport to address specificcomponents covered in other standards.Any safety areasassociated with the medical products use will not be addressedin this standard.This standard does not purport to address allof the safety 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:2F2027 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 Biomedical andTissue Engineered Medical Product ApplicationsF2103 Guide for Characterization and Testing of ChitosanSalts as Starting Materials Intended for Use in Biomedicaland Tissue-Engineered Medical Product ApplicationsF2131 Test Method forIn Vitro Biological Activity of Re-combinant Human Bone Morphogenetic Protein-2(rhBMP-2)Using the W-20 Mouse Stromal Cell LineF2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-ucts2.2 Federal Documents:3US FDA CFR 21,Part 3 3.2(e)Product Jurisdiction21 CFR Parts 16 and 1270 Human Tissues,Intended forTransplantation21 CFR Parts 207,807,and 1271 Human Cells,Tissues,andCellular and Tissue-Based Products:Establishment Reg-istration and Listing2.3 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices43.Terminology3.1 tissue engineering,nthe application,in vivo and invitro,of scientific principles and technologies to form tissueengineered medical products(TEMPs)used for medical treat-ments and as diagnostics.The various technologies and prin-ciples are common practices and methods in engineering andbiomedical sciences such as cell,gene,or drug therapy,embryology or other forms of developmental biology,surgicalmethods and technologies used to create traditional devices andbiologics.Tissue engineering could be applied to create prod-ucts for non-human use as well.3.2 tissueengineeredmedicalproducts(TEMPs),nmedical products that repair,modify,or regenerate therecipients cells,tissues,and organs,or their structure andfunction,or combination thereof.TEMPs may achieve atherapeutic potential from cells,biomolecules,scaffolds,andother materials,and processed tissues and derivatives used invarious combinations or alone.TEMPs are unique from con-ventional organ transplants.TEMPs may be used in vivo or invitro for disease,injury,elective surgery,and as a diagnostic.3.3 For other definitions used in this classification,refer tothe terms developed by the subcommittee on tissue engineeredmedical products terminology.3.3.1 DiscussionASTM Committee F04 is continuing torefine definitions for tissue engineered medical products1This classification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.41 on Classification and Terminology for TEMPs.Current edition approved Oct.1,2013.Published December 2013.Originallyapproved in 2002.Last previous edition approved in 2004 as F2211 04,which waswithdrawn in January 2013 and reinstated in October 2013.DOI:10.1520/F2211-13.2For 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.3Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401.4Available from International Organization for Standardization(ISO),1 rue deVaremb,Case postale 56,CH-1211,Geneva 20,Switzerland.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1(TEMPs)and related areas.A terminology standard forTEMPS will be published.3.4 For specific definitions related to specific standards,refer to the general index and the individual sta