ASTM F2312-2011 Standard Terminology Relating to Tissue Engineered Medical Products《组织工程医疗产品的相关标准术语》.pdf

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1、Designation: F2312 11Standard 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

2、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 (TE

3、MPs). 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

4、 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 addr

5、ess 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 P

6、arts 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 also

7、prompted 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 ASTMTEMP

8、s 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 th

9、ese new products known as TEMPs. Forinstance, the definition for somatic cell therapy as stated in the“Guidance for Human Somatic Cell Therapy and GeneTherapy” (4)3is recognized in this terminology. However, forthe purposes of TEMPs that contain cells, we have added thedefinition of “cell” which is

10、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,transfo

11、rm, 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 tis

12、sue 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

13、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 app

14、lications. 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.4. Terminologyadventitious agents, nan unintentionally introduced micro-biological or other infectious contaminant. In

15、 the productionof TEMPs, these agents may be unintentionally introducedinto the process stream or the final product, or both.1This terminology is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.41 on Classif

16、ication 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

17、Stop: SDE, Washington, DC 20401.3The boldface numbers in parentheses refer to the list of references at the end ofthis standard.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.FIG. 1 Relationships of the Fields of Tissue Engineering

18、to Tissue Engineered Medical ProductsF2312 112alginate, npolysaccharide obtained from some of the morecommon species of marine algae, consisting of an insolublemix of calcium, magnesium, sodium, and potassium salts.DISCUSSIONAlginate exists in brown algae as its most abundantpolysaccharide, mainly o

19、ccurring in the cell walls and intercellularspaces of brown seaweed and kelp. Alginates main function is tocontribute to the strength and flexibility of the seaweed plant. Alginateis classified as a hydrocolloid. The most commonly used alginate issodium alginate. Sodium alginate and, in particular,

20、calcium cross-linked alginate gels are used in Tissue Engineered Medical Products(TEMPs) as biomedical matrices, controlled drug delivery systems, andfor immobilizing living cells.allogeneic or allogenic, adjcells, tissues, and organs inwhich the donor and recipient are genetically differentindividu

21、als of the same species. Synonyms: allograft andhomograft.allograft, na graft of tissue between individuals of the samespecies but of disparate genotype. Called also allogeneicgraft and homograft.APA bead, nalginate-poly-L-lysine-alginate bead.autograft, na graft of tissue derived from another site

22、in oron the body of the organism receiving it.autologous, adjcells, tissues, and organs in which the donorand recipient is the same individual. Synonyms: autogenous,autograft,orautotransfusion,aself-to-self graft.bioactive agents, nany molecular component in, on, or withthe interstices of a device t

23、hat is intended to elicit a desiredtissue or cell response.DISCUSSIONGrowth factors, antibiotics, and antimicrobials are typi-cal examples of bioactive agents. Device structural components ordegradation byproducts that evoke limited localized bioactivity are notincluded.biocompatibility, na material

24、 may be considered biocom-patible if the materials perform with an appropriate hostresponse in a specific application.biological product, n“any virus, therapeutic serum, toxin,antitoxin, vaccine, blood, blood component or derivative,allergenic product, or analogous product, or arsphenamine orits der

25、ivatives (or any trivalent organic arsenic compound)applicable to the prevention, treatment, or cure of diseases orinjuries of man.” (5).DISCUSSION The term analogous product is interpreted to encom-pass somatic cell and gene therapy (13). A biological product may beused as a component of a TEMP. Fo

26、r the purposes of TEMPs, thesebiological products may be of any origin (that is, organism), tissue type,developmental stage, and may be living, non-living, and genetically orotherwise modified.biomaterial, nany substance (other than a drug), synthetic ornatural, that can be used as a system or part

27、of a system thattreats, augments, or replaces any tissue, organ, or function ofthe body.biomolecule, na biologically active peptide, protein, carbo-hydrate, vitamin, lipid, or nucleic acid produced by andpurified from naturally occurring or recombinant organisms,tissues or cell lines or synthetic an

28、alogs of such molecules.A biomolecule may be used as a component of a TEMP.biomolecule therapy, nthe use of biomolecules to repair,modify, or regenerate the recipients cells, tissues, or organsor their structure and function, or both. Biomolecule therapytechnologies can be applied in tissue engineer

29、ing to generateTEMPs.cell, n“the smallest structural unit of an organism that iscapable of independent functioning, consisting of one ormore nuclei, cytoplasm, and various organelles, all sur-rounded by a semipermeable cell membrane” (7).DISCUSSIONCells are highly variable and specialized in both st

30、ruc-ture and function, though all must at some stage synthesize proteins andnucleic acids, use energy, and reproduce. A cell or cells may be of anyorigin (that is, organism), tissue type, developmental stage, and may beliving, non-living, and genetically or otherwise modified. Cells may beused as a

31、component of a TEMP.cell culture, nthe in vitro growth or maintenance of cells.cell therapy, nthe administration of cells (any kind andform) to repair, modify or regenerate the recipients cells,tissues, and organs or their structure and function, or both.Cell therapy technologies can be applied in t

32、issue engineer-ing to generate TEMPs.channelyzer, na pulse height analyzer; places voltage pulsesinto appropriate size bins for the size distribution data.chitosan, na linear polysaccharide consisting of b(14)linked 2-acetamido-2-deoxy-D-glucopyranose (GlcNAc)and 2-amino-2-deoxy-D-glucopyranose (Glc

33、N). Chitosan isa polysaccharide derived by N-deacetylation of chitin.coincidence, nmore than one cell transversing the apertureat the same time.collagen, nType I collagen is a member of a family ofstructural proteins found in animals.DISCUSSIONType I collagen is part of the fibrillar group of colla-

34、gens. It derives from the COL1A1 and COL1A2 genes, which expressthe alpha chains of the collagen. All collagens have a unique triplehelical structure configuration of three polypeptide units known asalpha-chains. Proper alignment of the alpha chains of the collagenmolecule requires a highly complex

35、enzymatic and chemical interactionin vivo. As such, preparation of the collagen by alternate methods mayresult in improperly aligned alpha chains and, putatively, increase theimmunogenicity of the collagen. Collagen is high in glycine, L-alanine,L-proline, and 4-hydroxyproline, low in sulfur, and co

36、ntains noL-tryptophan. Natural, fibrillar Type I collagen is normally soluble indilute acids and alkalis. When heated (for example, above approxi-mately 40C), collagen is denatured to single alpha chains (gelatin). Ateach end of the chains are short non-helical domains called telopep-tides, which ar

37、e removed in some collagen preparations. Throughnon-covalent interactions with sites on adjacent helixes, fibrillogenesisis achieved. Subsequently, non-reducible cross-links are formed. TypeI collagen can be associated with Type III and Type V collagen and alsowith the other non-collagenous proteins

38、 like elastin and other structuralmolecules like glycosaminoglycans and complex lipoproteins bination product, nas defined in 21 CFR 3.2(e), theterm combination product includes: (1) A product comprisedof two or more regulated components, that is, drug/device,biologic/device, drug/biologic, or drug/

39、device/biologic, thatare physically, chemically, or otherwise combined or mixedand produced as a single entity; (2) Two or more separateproducts packaged together in a single package or as a unitand comprised of drug and device products, device andbiological products, or biological and drug products

40、; (3)Adrug, device, or biological product packaged separately thatF2312 113according to its investigational plan or proposed labeling isintended for use only with an approved individually speci-fied drug, device, or biological product where both arerequired to achieve the intended use, indication, o

41、r effect andwhere upon approval of the proposed product the labeling ofthe approved product would need to be changed, for ex-ample, to reflect a change in intended use, dosage form,strength, route of administration, or significant change indose; or (4) Any investigational drug, device, or biological

42、product packaged separately that according to its proposedlabeling is for use only with another individually specifiedinvestigational drug, device, or biological product whereboth are required to achieve the intended use, indication, oreffect.” Furthermore, “many somatic cell products adminis-tered

43、to patients will be combinations of a biological productand a device or of a drug, a biological product, and adevice.” (8). The term “combination product” may apply toTEMPs.corrected count, nthe cell count corrected for coincidence.cross-contamination, nthe unintended presence of a cell ora material

44、 with another cell or material.degree of deacetylation, nthe fraction or percentage ofglucosamine units (GlcN: deacetylated monomers) in achitosan polymer molecule.depolymerization, nreduction in length of a polymer chainto form shorter polymeric units. Depolymerization mayreduce the polymer chain t

45、o oligomeric or monomeric units,or both.dermal autograft, na skin autograft from which epidermisand subcutaneous fat have been removed; used instead offascia4in various plastic surgery procedures.device, n“an instrument, apparatus, implement, machine,contrivance, implant, in vitro reagent, or other

46、similar orrelated article.intended for use in the diagnosis of disease orother conditions, or in the cure, mitigation, treatment, orprevention of disease, in man or other animals,.which doesnot achieve its primary intended purposes through chemicalaction within or on the body of man or other animals

47、 andwhich is not dependent upon being metabolized for theachievement of its primary intended purposes.” Devices are“intended to affect the structure or any function of the body.”(Section 201(h)(1) (9).DISCUSSIONDevice Criteria: “A liquid, powder, or other similarformulation intended only to serve as

48、 a component, part or accessory toa device with a primary mode of action that is physical in nature” (10).A device may be used as a component of a TEMP.disinfection, nthe destruction or reduction of pathogenic andother kinds of microorganisms by thermal or chemicalmeans (for example, alcohol, antibi

49、otics, germicides).donor, na living or deceased organism who is the source ofcells or tissues, or both, for research or further processing fortransplantation in accordance with established medical cri-teria and procedures.dressing, nany of various materials utilized for covering andprotecting a wound.drug, n“articles intended for use in the diagnosis, cure,mitigation, treatment, or prevention of disease in man orother animals.” Drugs are “intended to affect the structure orany function of the body of man or o