分享
ASTM_F_2210_-_02.pdf
下载文档

ID:190543

大小:65.90KB

页数:6页

格式:PDF

时间:2023-03-04

收藏 分享赚钱
温馨提示:
1. 部分包含数学公式或PPT动画的文件,查看预览时可能会显示错乱或异常,文件下载后无此问题,请放心下载。
2. 本文档由用户上传,版权归属用户,汇文网负责整理代发布。如果您对本文档版权有争议请及时联系客服。
3. 下载前请仔细阅读文档内容,确认文档内容符合您的需求后进行下载,若出现内容与标题不符可向本站投诉处理。
4. 下载文档时可能由于网络波动等原因无法下载或下载错误,付费完成后未能成功下载的用户请联系客服处理。
网站客服:3074922707
TM_F_2210_ _02
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 year 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 organsused 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 culturecomponents,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 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 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,tissues,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 arsphenamineor 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 componentof 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 unit 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 and 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 term“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 together 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 approved 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,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 required 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

此文档下载收益归作者所有

下载文档
猜你喜欢
你可能关注的文档
收起
展开