1、Designation:F 2210 02Standard Guide forProcessing Cells,Tissues,and Organs for Use in TissueEngineered Medical Products1This standard is issued under the fixed designation F 2210;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the ye
2、ar of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide describes the processing,characterization,production,and quality assurance of cells,tissues,and organsuse
3、d for Tissue Engineered Medical Products(TEMPs).Itconcerns aspects of processing activities for cells,tissues,andorgans to be further processed.These aspects include:(1)cell,tissue,and organ processing(that is,facility,reagents,andprocedures for receipt,inspection,and storage;tissue culturecomponent
4、s,biological risk factors,and processing area),(2)donors(human and nonhuman)and screening,and(3)cell,tissue,and organ characterization and processing.1.2 This guide does not apply to any medical products ofhuman origin regulated by the U.S.Food and Drug Adminis-tration(FDA)under 21 CFR Parts 16 and
5、1270(1)2and 21CFR Parts 207,807,and 1271(2).1.3 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
6、 requirements prior to use.2.Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 allogeneic or allogenic,adjcells,tissues,and organsin which the donor and recipient are genetically differentindividuals of the same species.Synonyms:allograft andhomograft.2.1.2 autologous,adjcells,tiss
7、ues,and organs in whichthe donor and recipient is the same individual.Synonyms:autogenous,autograft,or autotransfusion,a self-to-self graft.2.1.3 biological product,n“any virus,therapeutic serum,toxin,antitoxin,vaccine,blood,blood component or deriva-tive,allergenic product,or analogous product,or a
8、rsphenamineor its derivatives(or any trivalent organic arsenic compound)applicable to the prevention,treatment,or cure of diseases orinjuries of man.”(3)The term“analogous product”is inter-preted to encompass somatic cell and gene therapy(21 CFR600.3(h).A biological product may be used as a componen
9、tof a TEMP.For the purposes of TEMPs,these biologicalproducts may be of any origin(that is,organism),tissue type,developmental stage,and may be living,non-living,andgenetically or otherwise modified.2.1.4 cell culture,nthe in vitro growth or maintenance ofcells.2.1.5 cell,n“the smallest structural u
10、nit of an organismthat is capable of independent functioning,consisting of one ormore nuclei,cytoplasm,and various organelles,all surroundedby a semipermeable cell membrane.”(4)Cells are highlyvariable and specialized in both structure and function,thoughall must at some stage synthesize proteins an
11、d nucleic acids,use energy,and reproduce.A cell or cells may be of any origin(that is,organism),tissue type,developmental stage,and maybe living,non-living,and genetically or otherwise modified.Cells may be used as a component of a TEMP.2.1.6 combination product,n“As defined in 21 CFR 3.2(e),the ter
12、m“combination product”includes:(1)A productcomprised of two or more regulated components,that is,drug/device,biologic/device,drug/biologic,or drug/device/biologic,that are physically,chemically,or otherwise com-bined or mixed and produced as a single entity;(2)Two ormore separate products packaged t
13、ogether in a single packageor as a unit and comprised of drug and device products,deviceand biological products,or biological and drug products;(3)Adrug,device,or biological product packaged separately thataccording to its investigational plan or proposed labeling isintended for use only with an app
14、roved individually specifieddrug,device,or biological product where both are required toachieve the intended use,indication,or effect and where uponapproval of the proposed product,the labeling of the approvedproduct would need to be changed,for example,to reflect achange in intended use,dosage form
15、,strength,route ofadministration,or significant change in dose;or(4)Anyinvestigational drug,device,or biological product packagedseparately that according to its proposed labeling is for useonly with another individually specified investigational drug,device,or biological product where both are requ
16、ired toachieve the intended use,indication,or effect.”Furthermore,“many somatic cell products administered to patients will be1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.43 on Tissue Engineered Biomaterials.Current edition approved Nov.10,2002.Published January 2003.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.1Copyright ASTM Internat