ASTM F2809-2010 Standard Terminology Relating to Medical and Surgical Materials and Devices《与内科外科材料和设备有关的标准术语》.pdf

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1、Designation: F2809 10Standard Terminology Relating toMedical and Surgical Materials and Devices1This standard is issued under the fixed designation F2809; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A

2、 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 standard is a repository for the terms,and their standardized definitions, as relates to the technicalstandards gener

3、ated by ASTM Committee F04 on Medical andSurgical Materials and Devices. The meanings and explana-tions of the technical terms have been written for both thenon-expert and the expert user.1.2 The terms are listed in alphabetical sequence; in Appen-dix X1 they are listed by the subcommittee of origin

4、.1.3 At a minimum, this standard is updated annually (at atime corresponding to the publication of the Annual Book ofASTM Standards containing this terminology standard) toeditorially include any terms approved in the Committeestechnical standards.1.4 The originating standard of each term is include

5、d forinformational purposes, following each listing of a term and itsassociated definition.2. Referenced Documents2.1 Historical ASTM Standards:2F921 Terminology Relating to Hemostatic ForcepsF1078 Terminology for Surgical ScissorsInserted andNon-Inserted BladesF1251 Terminology Relating to Polymeri

6、c Biomaterials inMedical and Surgical DevicesF1582 Terminology Relating to Spinal ImplantsF1638 Terminology for Surgical Tissue/Dressing/Pick-UpForceps (Thumb-Type)F1840 Terminology for Surgical Suture NeedlesF2005 Terminology for Nickel-Titanium Shape MemoryAlloysF2312 Terminology Relating to Tissu

7、e Engineered MedicalProductsNOTE 1The definition for each term is accompanied by a reference tothe standard from which it originated. All active standards of theCommittee may therefore be considered references, and are not repro-duced here.3. Significance and Use3.1 All approved F04 standards have t

8、heir terms reproducedin this terminology document, per section 1.3. The terms arelisted both alphabetically, and by subcommittee of origin, persection 1.2.3.1.1 This standard maintains a single source for terminol-ogy reference for ASTM Committee F04.3.1.2 This standard assists in the authoring of n

9、ew ASTMstandards, and standard revisions, where authors can find andutilize existing terms to avoid generation of extraneous, dupli-cative, or contradicting terms.3.2 Some terms may appear more than once.3.2.1 In some cases, multiple definitions of a term areneeded, based on the variety of applicati

10、ons and sectors towhich it applies.3.2.2 Because this terminology standard is a repository forall approved terms of Committee F04, it may become evidentthat multiple definitions for a term have been developed, butneed coordination.3.2.2.1 An objective of this document is to make duplicationevident,

11、and to facilitate harmonization of terms by CommitteeF04 as appropriate.3.3 Appendix X2 provides background on the history andobjectives of this terminology standard.4. Terminologyaccelerator, nadditive used to increase the rate of cure. Anaccelerator may also be a catalyst, or it may actually chang

12、ecomposition and, therefore, not qualify as a catalyst. F602acetal plastic, nplastic based on polymers having a pre-dominance of acetal linkages in the main chain. (See alsopolyoxymethylene.) F1251acousto-electric transfer function, HSE, nelectrical input tothe IMEHD output transducer E produced by

13、a sound field,divided by the input sound field pressure pS:HSE= E/pS.F2504DISCUSSIONHSEwill depend on the particular gain settings used, forexample, full-on gain or minimal gain. The gain should be reportedwhenever that transfer function is used.1This terminology is under the jurisdiction ofASTM Com

14、mittee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.97 on Editorial and Terminology.Current edition approved Aug. 15, 2010. Published December 2010. DOI:10.1520/F280910.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcon

15、tact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.acousto-vibrational t

16、ransfer function (IMEHD aided),HSVA, nstapes velocity (IMEHD aided) divided by theinput sound field pressure: HSVA=vA/pS. F2504DISCUSSIONThis quantity can be measured directly or computedfrom the product of the electro-vibrational transfer function, HEV, andthe acousto-electric transfer function, HS

17、E, measured in the IMEHD-aided condition: HSVA=vA/pS.acousto-vibrational transfer function (unimplanted), HSVU,nstapes velocity (unimplanted) when driven by the inputsound field, divided by the input sound field pressure:HSVU=vU/pS. F2504DISCUSSIONThis quantity can be measured directly or computedfr

18、om the product of the middle-ear transfer function, HTV, and theear-canal transfer function, HST, measured in the unimplanted condi-tion: HSVU=vU/pS=HSTHTV.acrylic plastic, nplastic based on polymers made withacrylic acid or a structural derivative of acrylic acid.F1251activator, nmedical material t

19、hat demonstrates a shortenedclotting time; an initiator of the intrinsic coagulation path-way. F2382active austenite finish temperature, n(in nitinol), termused to denote austenite finish temperature of a finishedwire, tube, or component as determined by a bend and freerecovery method rather than by

20、 DSC. F2005addition polymerization, npolymerization in which mono-mers are linked together without the splitting off of water orother simple molecules and involves the opening of a doublebond. F1251additive, nchemical added to epoxy resins or hardeners tomodify the handling characteristics or cured

21、properties, orboth, of the epoxy-hardener combination. F602diluent, nchemical used in admixture to modify or en-hance the properties of either or both the uncured or curedformulations. A primary use is to reduce the viscosity of themixed system although other properties such as exothermrate, stiffne

22、ss, moisture absorption, and so forth, may bemodified or enhanced also. F602filler, na relatively inert solid particulate material added toan epoxy formulation to modify its strength, permanence,working properties, or other qualities, or to lower costs.F602nonreactive diluent, na diluent not contain

23、ing chemicallyreactive functional groups. F602reactive diluent, na diluent that reacts chemically with theepoxy resin or hardener, or both, during cure. F602additives, ncomponent of a silicone elastomer used inrelatively small amounts to perform functions such asmarking, coloring, or providing opaci

24、ty to the elastomer.F2038adhesion, nphysiochemical state by which a cell is coupledto a non-cell surface by interfacial forces, which may consistof covalent or ionic forces. F2664adhesive failure, nfailure of the adhesive/substrate bond.F2548adhesive strength, nstrength of the tissue adhesive/substr

25、ateinterface. F2548adventitious agents, nunintentionally introduced microbio-logical or other infectious contaminant. In the production ofTEMPs, these agents may be unintentionally introduced intothe process stream or the final product, or both. F2212,F2312adventitious agents, nunintentionally intro

26、duced microbio-logical or other infectious contaminant. In the production ofTEMPs, these agents may be unintentionally introduced intothe manufacturing process or into the final product or both.(See Terminology F2312.) F2383DISCUSSIONIn this guide, adventitious agents also include micro-biological o

27、r other infectious contaminants that may be endogenous tothe starting cells or tissue.aging, nthe process of exposing materials to an environmentfor an interval of time. F1251aging effect, nchange in a material brought about byexposure of the material to an environment for an interval oftime. F1251a

28、lginate, 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 occurring in the cell walls and intercellularspa

29、ces 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, calcium cross-linked alginate gels are used in

30、Tissue Engineered Medical Products(TEMPs) as biomedical matrices, controlled drug delivery systems, andfor immobilizing living cells. F2259, F2312, F2315alkyd resin, npolyester convertible into a crosslinked form;requiring a reactant of functionality higher than two, orhaving double bonds. F1251allo

31、geneic or allogenic, adjcells, tissues, and organs inwhich the donor and recipient are genetically differentindividuals of the same species. Synonyms: allograft andhomograft. F2312allogeneic, adjderived from different individuals of the samespecies. F1581F2809 102allograft, ngraft of tissue between

32、individuals of the samespecies but of disparate genotype. Called also allogeneicgraft and homograft. Dorlands,3F2311, F2312alloy phase, nin a shape memory alloy, the crystal structurestable at a particular temperature and stress. F2005amorphous calcium phosphate, nnoncrystalline calciumphosphate. F1

33、609anchor, nbioabsorbable device or a component of a bioab-sorbable device that provides the attachment to the bone.F2502anchor, ncomponents that are directly attached to the bonyelements of the spine (sacrum, lamina, pedicle, vertebralbody, spinous process, transverse process, the pelvis, orribs).

34、F1582angle, ndefined at either the barrel/sideplate or blade/sideplate junction (see Fig. 1 and Fig. 2 of SpecificationF384). F384angled device, nclass of orthopedic devices for the fixationof fractures in the methaphyseal areas of long bones that hasa component aligned at an angle to the bones long

35、 axis.F384anneal, vto heat treat in order to remove the effect ofcold-working. F2005anorganic, adjdenoting tissue (for example, bone) fromwhich the organic material has been totally removed. Alsoreferred to as deorganified, deproteinized or deproteinated.F1581anterior curvature, ncondylar design whi

36、ch is generallyplanar except for a concaveupward region anteriorly onthe tibial component. F1223anterior posterior (AP), nany geometrical length alignedwith the AP orientation. F1223antigens, nthese are substances that stimulate the host toproduce an immune response. F1905AOO, nacetone olive oil sol

37、ution (4:1 v/v) is a suitablenonpolar solvent. F2148AP displacement, nrelative linear translation between com-ponents in the AP direction. F1223AP draw load, nforce applied to the movable componentwith its vector aligned in the AP direction causing orintending to cause an AP displacement. F1223APA b

38、ead, nalginate-poly-L-lysine-alginate bead.F2312, F2315apatite, nmineral substance having the molecular formulaCa10(X)2(PO4)6where X=OH (hydroxyapatite or hydroxy-lapatite), CO3(carbonated apatite), F or C1 (8). F1581apparent density, nsee density, apparent. F1251aqueous solvent, nin this assay refe

39、rs to the polar solvent,saline. F2148articular insert, npolymeric prosthetic portion of a multiplepiece glenoid component that articulates with the humeralhead. F1829artifact width, nmaximum distance (mm) from the edge ofthe implant to the fringe of the resulting image artifact foundin the entire se

40、t of images acquired using this test method.F2119artificial intervertebral disc, nsynthetic structure that ispermanently implanted in the disc space between twoadjacent vertebral bodies to provide spinal column supportand allow intervertebral motion. F2346artificial weathering, nexposure of a materi

41、al to laboratoryconditions that simulate outdoor weathering.DISCUSSIONExposure conditions may be cyclic, involving changesin temperature, relative humidity, radiant energy, and many otherelements found in the atmosphere in various geographical areas. Thelaboratory exposure conditions are usually int

42、ensified beyond thoseencountered in actual out-door exposure to accelerate the effect.F1251assembly, ncomplete implant configuration (not includingspine, pelvis, ribs, or substitute material) as intended forsurgical use. F1582atraumatic, advteeth that would interdigitate except forbeing spaced apart

43、 a predesigned distance so they will notstress, crush, or otherwise traumatize the tissue beinggrasped. F1638attachment area, nportion of the needle where the attach-ment of the suture takes place. For example, eyed, drilled,and channel. F1840austenite, nhigh temperature parent phase in Ni-Ti shapem

44、emory alloys with a B2 crystal structure. This phasetransforms to R-phase or martensite, or both, on cooling.F2005austenite finish temperature (Af), n(in nitinol), tempera-ture at which the martensite to austenite transformation iscompleted on heating in a single-stage transformation (Fig.1) or the

45、temperature at which the R-phase to austenitetransformation is completed on heating in a two-stagetransformation (Fig. 2). F2005austenite peak temperature (Ap), n(in nitinol), temperatureof the endothermic peak position on the differential scanningcalorimeter (DSC) curve upon heating for the martens

46、ite toaustenite transformation in a single-stage transformation(Fig. 1) or the temperature of the endothermic peak positionon the DSC curve upon heating for the R-phase to austenite3Dorland, WAN, Dorlands Illustrated Medical Dictionary, 29th Ed., W.B.Saunders Company, Philadelphia, 2000.FIG. 1 DSC G

47、raph for a Single-Stage Transformation (SourceF2005)F2809 103transformation in a two-stage transformation (Fig. 2).F2005austenite start temperature (As), n(in nitinol), temperatureat which the martensite to austenite transformation begins onheating in a single-stage transformation (Fig. 1)orthetempe

48、rature at which the R-phase to austenite transformationbegins on heating in a two-stage transformation (Fig. 2).F2005auto compression, ntype of bone plate that by its design cangenerate a compressive force between adjacent unconnectedbone fragments through the use of one or more ramped holesor anoth

49、er type of slot geometry. This ramp or slot geometrycontacts the underside of the screw head, and inducescompressive force as the screw is inserted and tightened tothe bone plate. F382autograft, ngraft of tissue derived from another site in or onthe body of the organism receiving it.Dorlands, F2311, F2312autologous, adjcells, tissues, and organs in which the donorand recipient is the same individual. Synonyms: autogenous,autograft,orautotransfusion,aself-to-self graft. F2312axial load; axial translation, nf