ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates.pdf

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1、Designation: F382 17Standard Specification and Test Method forMetallic Bone Plates1This standard is issued under the fixed designation F382; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A number in par

2、entheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification and test method is intended to providea comprehensive reference for metallic bone plates used in thesurgical internal fixation of

3、 the skeletal system. The standardestablishes consistent methods to classify and define thegeometric and performance characteristics of bone plates. Thestandard also presents a catalog of standard specifications thatspecify material; labeling and handling requirements; andstandard test methods for m

4、easuring 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-specific clinical performance for boneplates, as insufficient knowledge is available to predic

5、t 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 the surgical internal fixation of the skeletalsystem.1.3 This document may not be appropriat

6、e 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 test methods usedin determining the following bone plate mechanical perfor-mance characterist

7、ics:1.4.1 Standard Test Method for Single Cycle Bend Testingof Metallic Bone PlatesAnnex A1, and1.4.2 Standard Test Method for Determining the BendingFatigue Properties Of Metallic Bone PlatesAnnex A2.1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are

8、included in thisstandard.1.6 Multiple test methods are included in this standard.However, it must be noted that the user is not obligated to testusing all of the described methods. Instead, the user shouldonly select test methods that are appropriate for a particulardevice design. In most instances,

9、 only a subset of the hereindescribed test methods will be required.1.7 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, health and environmental practices and

10、deter-mine the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-me

11、ndations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E122 Practice for Calculating Sample Size to Estimate, WithSpecified Precision, the Average for a Characteristic of aLot or ProcessF565 Practice for Care and Handling

12、 of Orthopedic Implantsand InstrumentsF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment2.2 ISO Standard:3ISO 9585 Implants for SurgeryDetermination of BendingStrength and St

13、iffness of Bone PlatesISO 14602 Non-active surgical implantsImplants for Os-teosynthesis particular requirements.3. Terminology3.1 DefinitionsGeometric:3.1.1 auto compressiona type of bone plate that by itsdesign can generate a compressive force between adjacent1This specification and test method is

14、 under the jurisdiction of ASTM Commit-tee F04 on Medical and Surgical Materials and Devices and is the directresponsibility of Subcommittee F04.21 on Osteosynthesis.Current edition approved Sept. 1, 2017. Published October 2017. Originallyapproved in 1973. Last previous edition approved in 2014 as

15、F382 14. DOI:10.1520/F0382-17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American Nation

16、al Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized pri

17、nciples on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1unconnected bone fragments through the use of one or moreramped holes or

18、another type of slot geometry. This ramp orslot geometry contacts the underside of the screw head, andinduces 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

19、at leasttwo dimensions (width and thickness) which generally are notthe same in magnitude. The device 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 cer

20、clage wire. Apartial list of general types of bone plates is given in Section4.1.3.1.3 bone plate length, L (mm)the linear dimension of thebone plate measured along the longitudinal axis as illustrated inFig. 2.3.1.4 bone plate thickness, b (mm)the linear dimension ofthe bone plate measured parallel

21、 to the screw hole axis asshown Figs. 1a, 1b, and 2. For a bone plate with a crescentsection, the thickness is measured at the thickest point alongthe 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 F

22、ig. 2.3.1.6 contouringthe manipulation and bending of a boneplate, either pre-operatively or 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

23、is not constant along the section. Typically thesection is thickest along the bone plates centerline 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/

24、Structural:3.2.1 bending stiffness, K (N/mm) of a bone plate, themaximum slope of the linear 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

25、to produce a 0.2 % offset displacement inthe bone plate when tested as described in Annex A1.3.2.3 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 accord

26、ing to the method described inAnnex A1.3.2.4 fatigue life, nthe number of loading cycles of 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,

27、stress,and so on) at a given load ratio, for which 50 % of thespecimens within a given sample 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:

28、4.1.1 Cloverleaf PlateA bone plate that has one three-lobed end which contains screw holes.4.1.2 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 Reconstr

29、uction PlateAbone plate that does not havea uniform width, but usually has a smaller cross-sectionbetween the screw holes or slots. The reduced cross-sectionFIG. 1 Bone Plate Cross-sectionsF382 172between screw holes/slots facilitates contouring the bone platein several planes. Reconstruction plates

30、 are often used infractures of the pelvis and acetabulum.4.1.4 Straight PlateA bone plate with uniform width anda straight longitudinal axis. Straight plates are often used forfractures of the diaphyses of long bones.4.1.5 Tubular PlateA bone plate whose cross-sectionresembles a portion of a tube, a

31、nd which has a constantthickness or a crescent section. Tubular plates are often usedfor fractures of the smaller long bones (that is, radius, ulna,fibula).5. Marking, Packaging, Labeling, and Handling5.1 Dimensions of bone plates should be designated by thestandard definitions given in Section 3.1.

32、5.2 Bone plates shall be marked using a method specified inaccordance with either Practice F983 or ISO 14602.5.3 Markings on bone plates shall identify the manufactureror distributor and shall be located away from the most highlystressed areas, where possible.5.4 Packaging shall be adequate to prote

33、ct 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;5.5.4 Material and, where applicable, its associated ASTMspecification designation number;5.

34、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-dance with Practice F565, as appropriate.5.7 Consider Practice F2503 to identify potential haza

35、rdsproduced by interactions between the device and the MRenvironment and for terms that may be used to label the devicefor safety in the MR environment.6. Materials6.1 Bone plates shall be fabricated from a metallic materialintended for surgical implant applications. In addition, theFIG. 2 Bone Plat

36、e DimensionsF382 173materials shall be biocompatible for the intended application.Materials should be chosen based on the design requirementsof the particular device. ASTM subcommittee F04.12 main-tains a number of specifications for materials that are suitablefor surgical implant applications.7. Ge

37、neral Requirements and PerformanceConsiderations7.1 Geometric ConsiderationsBone plates that are in-tended to be used with bone screws shall have design features(screw holes or slots) that conform or appropriately fit thecorresponding bone screw.7.2 Pending PropertiesThis is a critical characteristi

38、c ofbone plates for orthopedic applications since the bone plateprovides the primary means of stabilizing the bone fragments.Additionally, the bending stiffness of the bone plate maydirectly affect the rate and completeness of healing.7.2.1 The relevant bending properties (bending stiffness,bending

39、structural stiffness, and bending strength) shall bedetermined using the standard test method of Annex A1.7.2.2 The relevant bending fatigue properties shall be deter-mined in accordance with the methods described in Annex A2.8. Keywords8.1 bend testingsurgical implants; fatigue test; bone plate;ort

40、hopedic medical devicesbone plates; surgical devices; testmethodssurgical implantsANNEXESA1. STANDARD TEST METHOD FOR 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 the intrinsic, structuralpro

41、perties of metallic bone plates. The test method measuresthe bending stiffness, bending structural stiffness, and bendingstrength of bone plates.A1.1.2 This test method is intended to provide a means tocharacterize mechanically different bone plate designs. It is notthe intention of this standard to

42、 define levels of performancefor bone plates as insufficient knowledge is available to predictthe consequences of the use of particular bone plate designs.A1.1.3 This test method is intended to evaluate the bendingstrength, bending structural stiffness, or the bending stiffness ofthe bone plate, and

43、 may not be appropriate for all situations.When the structurally critical region of the bone plate is shownto be located through a non-uniform region of the bone plate(i.e., a peri-prosthetic, contoured plate), it may be necessary toevaluate the bending strength, bending structural stiffness, orbend

44、ing stiffness of this region of the bone plate using adifferent test method. This is because it may not be physicallypossible to fit the non-uniform region between the loadingrollers of a four-point bend test. Structurally critical regionsmay be identified through such methods as hand calculations,F

45、inite Element Analysis, etc. Screw holes or other interlockingfeatures or contoured regions may be located at the proximal ordistal extremities of a bone plate, and may result in structurallycritical regions at these locations.A1.1.4 UnitsThe values stated in SI units are to beregarded as standard.

46、No other units of measurement areincluded in this standard.A1.1.5 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, health and environmental practices and deter-

47、mine the applicability 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 similar, but not equivalent to this test method.A1.2 Referenced Documents:A1.2.1 ASTM Standards

48、:2E4 Practices for Load Verification of Testing MachinesE122 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 % offset displacement, q (mm)permanentdeformation equal to 0.2 % of the center loading span distance.(poi

49、nt 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 SectionFIG. A1.1 Diagram Illustrating Methods for Determining the Bend-ing Properties of Bone PlatesF382 174A1.8 (the bending moment corresponding to point D in Fig.A1.1.). If the bone plate fractures before the proof point isattained the bending strength shall be defined as the bendingmoment at fracture.A1.3.1.3 bending structural stiffnes