ASTM_F_2312_-_11.pdf

Designation:F231211Standard Terminology Relating toTissue Engineered Medical Products1This standard is issued under the fixed designation F2312;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 terminology defines basic terms and presents therelationships of the scientific fields related to Tissue Engi-neered Medical Products(TEMPs).Committee F04 has de-fined these terms for the specific purpose of unifying thelanguage used in standards for TEMPs.1.2 The terms and relationships defined here are limited toTEMPs.They do not apply to any medical products of humanorigin regulated by the U.S.Food and Drug Administrationunder 21 CFR Parts 16 and 1270 and 21 CFR Parts 207,807,and 1271.1.3 The terms and nomenclature presented in this standardare for the specific purposes of unifying the language used inTEMP standards and are not intended for labeling of regulatedmedical products.1.4 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 Government Documents:221 CFR Parts 16 and 1270 Human Tissues,Intended forTransplantation(July 29,1997)21 CFR Parts 207,807,and 1271 Human Cells,Tissues,andCellular and Tissue-Based Products;Establishment Reg-istration and Listing(January 19,2001)3.Significance and Use3.1 The need for standards regarding TEMPs has alsoprompted a need for definitions.This terminology sets forthdefinitions of the most commonly used terms and specifies therelationship among the sciences and components applied intissue engineering to develop TEMPs.Use of these terms andan understanding of these relationships will unify the ASTMTEMPs standards with a common language such that the usersof these standards can understand and interpret the standardsmore precisely.Terms specific to a TEMP standard will also bedefined within the respective standard as appropriate.3.2 Defining TermsTerms are defined with a broad scopeto encompass these new products known as TEMPs.Forinstance,the definition for somatic cell therapy as stated in the“Guidance for Human Somatic Cell Therapy and GeneTherapy”(1)3is recognized in this terminology.However,forthe purposes of TEMPs that contain cells,we have added thedefinition of“cell”which is much broader and not limited tothe use of living cells.3.3 Clinical Effects of TEMPsThe users of this terminol-ogy should note that terms used regarding the clinical effects ofTEMPs,for instance,“modify or modification”of the patientscondition,may also be interpreted to“enhance,augment,transform,alter,improve,or supplement.”Similarly,“repair”may also serve to mean“restore.”3.4 The diagram in Fig.1 shows the relationships ofcomponents of TEMPs and of the fields of science(forexample,technologies and principles)used in tissue engineer-ing to create TEMPs.Certain TEMPs may be tissue engineeredor produced in vitro by using specific components and sciencesto create an off-the-shelf TEMP for the users.Other TEMPsmay by design require the users to place the components insidethe patient,(that is,in vivo)to rely upon the patientsregenerative potential to achieve the products primary in-tended purpose.The expectation of a TEMP used for therapeu-tic clinical applications is to have a therapeutic effect,specifi-cally to repair,modify or regenerate the recipients cells,tissues,and organs or their structure and function.Such aTEMP may be used for human and non-human applications.Inother applications,a TEMP may be used in diagnostic clinicalapplications,or both,to achieve an investigative outcome ofthe function of the cells,tissues,and organs.1This terminology is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.41 on Classification and Terminology for TEMPs.Current edition approved April 1,2011.Published May 2011.Originallyapproved in 2003.Last previous edition approved in 2010 as F2312 10.DOI:10.1520/F2312-11.2Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.3The boldface numbers in parentheses refer to the list of references at the end ofthis standard.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 FIG.1 Relationships of the Fields of Tissue Engineering to Tissue Engineered Medical ProductsF2312 112 4.Terminologyadventitious agents,nan unintentionally introduced micro-biological or other infectious contaminant.In the productionof TEMPs,these agents may be unin