ASTM F382-1999(2008)e1 Standard Specification and Test Method for Metallic Bone Plates《金属骨板的检测及标准规范》.pdf

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1、Designation: F 382 99 (Reapproved 2008)1Standard Specification and Test Method forMetallic Bone Plates1This standard is issued under the fixed designation F 382; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revi

2、sion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEUnits information was editorially corrected in August 2009.1. Scope1.1 This specification and test method is intended to providea comp

3、rehensive reference for bone plates used in the surgicalinternal fixation of the skeletal system. The standard estab-lishes consistent methods to classify, define the geometriccharacteristics, and performance characteristics of bone plates.The standard also presents a catalog of standard specificati

4、onsthat specify material; labeling and handling requirements; andstandard test methods for measuring performance relatedmechanical characteristics determined to be important to the invivo performance of bone plates.1.2 It is not the intention of the standard to define levels ofperformance or case-sp

5、ecific clinical performance for boneplates, as insufficient knowledge is available to predict theconsequences or their use in individual patients for specificactivities of daily living. Futhermore, it is not the intention ofthe standard to describe or specify specific designs for boneplates used in

6、the surgical internal fixation of the skeletalsystem.1.3 This document may not be appropriate for all types ofbone plates. The user is cautioned to consider the appropriate-ness of the standard in view of a particular bone plate and itspotential application.1.4 This document includes the following t

7、est methods usedin determining the following bone plate mechanical perfor-mance characteristics.1.4.1 Standard Test Method for Single Cycle Bend Testingof Metallic Bone PlatesAnnex A1.1.4.2 Standard Test Method for Determining the BendingFatigue Properties Of Metallic Bone PlatesAnnex A2.1.5 The val

8、ues stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 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 sa

9、fety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chrom

10、ium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 136 Specificatio

11、n for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 139 Specification for Wrought 18Chromium-14Nick

12、el-2.5Molybdenum Stainless Steel Sheet and Strip for Surgi-cal Implants (UNS S31673)F 543 Specification and Test Methods for Metallic MedicalBone ScrewsF 565 Practice for Care and Handling of Orthopedic Im-plants and InstrumentsF 620 Specification for Alpha Plus Beta Titanium AlloyForgings for Surgi

13、cal ImplantsF 621 Specification for Stainless Steel Forgings for SurgicalImplantsF 983 Practice for Permanent Marking of Orthopaedic Im-plant Components1This specification and test method is under the jurisdiction of ASTM Commit-tee F04 on Medical and Surgical Materials and Devices and is the direct

14、responsibility of Subcommittee F04.21 on Osteosynthesis.Current edition approved Nov. 1, 2008. Published November 2008. Originallyapproved in 1973. Last previous edition approved in 2003 as F 382 99(2003)1.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer

15、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.F 1295 Specification for Wrought Titaniu

16、m-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanad

17、ium Alloy for Surgical Implant Applications (UNSR56400)F 1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications(UNS R58130)2.2 ISO Standard:3FDIS 14602 Non-active surgical implantsImplants forOsteosynthesis particular requirements.3. Terminology3.1 Defi

18、nitionsGeometric:3.1.1 auto compressiona type of bone plate that by itsdesign can generate a compressive force between adjacentunconnected bone fragments through the use of one or moreramped holes or another type of slot geometry. This ramp orslot geometry contacts the underside of the screw head, a

19、ndinduces compressive force as the screw is inserted and tight-ened to the bone plate.3.1.2 bone platea metallic device with two or more holesor slot(s), or both, and a cross section that consists of at leasttwo dimensions (width and thickness) which generally are notthe same in magnitude. The devic

20、e is intended to providealignment and fixation of two or more bone sections, primarilyby spanning the fracture or defect. The device is typically fixedto the bone through the use of bone screws or cerclage wire. Apartial list of general types of bone plates is given in Section4.1.3.1.3 bone plate le

21、ngth, L (mm)the linear dimension ofthe bone plate measured along the longitudinal axis as illus-trated in Fig. 2.3.1.4 bone plate thickness, b (mm)the linear dimension ofthe bone plate measured parallel to the screw hole axis asshown in Fig. 1a, 1b, and Fig. 2. For a bone plate with acrescent sectio

22、n, the thickness is measured at the thickest pointalong the section.3.1.5 bone plate width, w (mm)the linear dimension of thebone plate measured perpendicular to both the length andthickness axes as shown in Fig. 2.3.1.6 contouringthe manipulation and bending of a boneplate, either pre-operatively o

23、r intra-operatively, to match theanatomic geometry of the intended fixation location.3.1.7 crescent sectiona bone plate cross-section shape(perpendicular to the long axis of the bone plate) where thethickness is not constant along the section. Typically thesection is thickest along the bone plates c

24、enterline and tapersto a smaller thickness at the bone plates edges (see Fig. 1b).3.1.8 uniform widthreferring to a bone plate where thewidth is constant along the bone plates length.3.2 DefinitionsMechanical/Structural:3.2.1 bending stiffness, K (N/mm) of a bone plate, themaximum slope of the linea

25、r elastic portion of the load versusload-point displacement curve for a bone plate when testedaccording to the test method of Annex A1.3.2.2 bending strength (N-m) of a bone plate, the bendingmoment necessary to produce a 0.2 % offset displacement inthe bone plate when tested as described in Annex A

26、1.3.2.3 bending structural stiffness, El (N-m2)of a boneplate, the bone plates normalized effective bending stiffnessthat takes into consideration the effects of the test setupsconfiguration when tested according to the method described inAnnex A1.3.2.4 fatigue life, nThe number of loading cycles of

27、 aspecified character that a given specimen sustains beforefailure of a specified nature occurs.3.2.5 fatigue strength at N cyclesAn estimate of the cyclicforcing parameter (for example, load, moment, torque, stress,and so on) at a given load ratio, for which 50 % of thespecimens within a given samp

28、le population would be ex-pected to survive N loading cycles.4. Classification4.1 Bone plates used in general orthopaedic surgery can becategorized into general types according to the followingclassifications.4.1.1 cloverleaf platea bone plate that has one three-lobedend which contains screw holes.4

29、.1.2 cobra head platea bone plate that has one flaredtriangular or trapezoidal end which contains multiple screwholes or slots, or both. This type of bone plate is often used forhip arthrodesis.4.1.3 reconstruction platea bone plate that does not havea uniform width, but usually has a smaller cross-

30、sectionbetween the screw holes or slots. The reduced cross-sectionbetween screw holes/slots facilitates contouring the bone platein several planes. Reconstruction plates are often used infractures of the pelvis and acetabulum.4.1.4 straight platea bone plate with uniform width and astraight longitud

31、inal axis. Straight plates are often used forfractures of the diaphysis of long bones.4.1.5 tubular platea bone plate whose cross-section re-sembles a portion of a tube, and which has a constant thicknessor a crescent section. Tubular plates are often used for fracturesof the smaller long bones (tha

32、t is, radius, ulna, fibula).3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.F 382 99 (2008)125. Marking, Packaging, Labeling, and Handling5.1 Dimensions of bone plates should be designated by thestandard definitions given

33、 in Section 3.1.5.2 Bone plates shall be marked using a method specified inaccordance with either Practice F 983 or ISO 14602.FIG. 2 Bone Plate DimensionsFIG. 1 Bone Plate Cross-sectionsF 382 99 (2008)135.3 Markings on bone plates shall identify the manufactureror distributor and shall be made away

34、from the most highlystressed areas, where possible.5.4 Packaging shall be adequate to protect the bone platesduring shipment.5.5 Package labeling for bone plates shall include whenpossible the following information:5.5.1 Manufacturer and Product Name,5.5.2 Catalog number,5.5.3 Lot or serial number,5

35、.5.4 Material and, where applicable, its associated ASTMspecification designation number,5.5.5 Number of screw holes,5.5.6 Bone plate width,5.5.7 Bone plate length,5.5.8 Bone plate thickness, and5.5.9 ASTM specification designation number.5.6 Bone plates should be cared for and handled in accor-danc

36、e with Practice F 565, as appropriate.6. Materials6.1 All bone plates made of materials which have anASTMcommittee F04 standard designation shall meet those require-ments given in the ASTM standards. A majority of materialshaving ASTM specifications can be found in the list ofreferenced ASTM standar

37、ds of Section 2.1.6.2 Bone plates of forged Specification F 136 shall meet therequirements of specification F 620.6.3 Bone plates of forged Specification F 138 shall meet therequirements of specification F 621.7. General Requirements and PerformanceConsiderations7.1 geometric considerationsbone plat

38、es that are intendedto be used with bone screws shall have design features (screwholes or slots) that conform or appropriately fit the correspond-ing bone screw.7.2 bending propertiesa critical characteristic of boneplates for orthopedic applications since the bone plate providesthe primary means of

39、 stabilizing the bone fragments.Addition-ally, the bending stiffness of the bone plate may directly affectthe rate and ability of healing.7.2.1 The relevant bending properties (bending stiffness,bending structural stiffness, and bending strength) shall bedetermined using the standard test method of

40、Annex A1.7.2.2 Determine the relevant bending fatigue propertiesaccording to the methods described in Annex A2.8. Keywords8.1 bend testingsurgical implants; fatigue test; bone plate;orthopedic medical devicesbone plates; surgical devices; testmethodssurgical implantsANNEXESA1. STANDARD TEST METHOD F

41、OR SINGLE CYCLE BEND TESTING OF METALLIC BONE PLATES1A1.1 Scope:A1.1.1 This test method describes methods for single cyclebend testing in order to determine intrinsic, structural proper-ties of metallic bone plates. The test method measures thebending stiffness, bending structural stiffness, and ben

42、dingstrength of bone plates.A1.1.2 This test method is intended to provide a means ofmechanically characterize different bone plate designs. It is notthe intention of this standard to define levels of performancefor bone plates as insufficient knowledge is available to predictthe consequences of the

43、 use of particular bone plate designs.A1.1.3 UnitsThe values stated in SI units are to beregarded as standard. No other units of measurement areincluded in this standard.A1.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibili

44、ty 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.NOTE A1.1There is currently an ISO standard (ISO 9585Implantsfor SurgeryDetermination of Bending Strength and Stiffness of BonePlates) that is

45、 similar, but not equivalent to this test method.A1.2 Referenced Documents:A1.2.1 ASTM Standards2:E 4 Practices for Load Verification of Testing MachinesE 122 Practice for Choice of Sample Size to Estimate theAverage Quality of a Lot or ProcessA1.3 Terminology:A1.3.1 Definitions:A1.3.1.1 0.2 % offse

46、t displacement, q (mm)permanentdeformation equal to 0.2 % of the center loading span distance.(point B in Fig. A1.1).A1.3.1.2 bending strength (N-m)of a bone plate, thebending moment necessary to produce a 0.2 % offset displace-ment in the bone plate when tested as described in SectionA1.8(the bendi

47、ng moment corresponding to point D in Fig. A1.1.).If the bone plate fractures before the proof point is attained thebending strength shall be defined as the bending moment atfracture.A1.3.1.3 bending structural stiffness, (EIe) (N-m2)of abone plate, the bone plates normalized effective bendingstiffn

48、ess that takes into consideration the effects of the testsetups configuration. For this test method, the bending struc-tural stiffness is determined from the single cycle bendingresponse of the bone plate and the testing configuration.A1.3.1.4 bending stiffness, K (N/mm)of a bone plate, themaximum s

49、lope of the linear elastic portion of the load versusload-point curve when tested as described in sectionA1.8. (Seethe slope of line Om in Fig. A1.1).F 382 99 (2008)14A1.3.1.5 bone plate width, w (mm)the width of the boneplate as shown in Fig. A1.3.A1.3.1.6 center span, a (mm)the distance between thetwo loading rollers as shown in Fig. A1.2.A1.3.1.7 fracture load, Fmax(N)the applied load at thetime when the bone plate fractures.A1.3.1.8 loading span, h (mm)the distance between theloading roller and the nearest support