ASTM F382-2014 Standard Specification and Test Method for Metallic Bone Plates《金属骨板的标准规格和试验方法》.pdf

1、Designation: F382 99 (Reapproved 2008)1F382 14Standard 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

2、 revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1 NOTEUnits information was editorially corrected in August 2009.1. Scope1.1 This specification and test method is intended to provide a c

3、omprehensive reference for bone plates used in the surgicalinternal fixation of the skeletal system. The standard establishes consistent methods to classify, classify and define the geometriccharacteristics, and performance characteristics of bone plates. The standard also presents a catalog of stan

4、dard specifications thatspecify material; labeling and handling requirements; and standard test methods for measuring performance related mechanicalcharacteristics determined to be important to the in vivo performance of bone plates.1.2 It is not the intention of the standard to define levels of per

5、formance or case-specific clinical performance for bone plates,as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of dailyliving. Futhermore, it is not the intention of the standard to describe or specify specific designs fo

6、r bone plates used in the surgicalinternal fixation of the skeletal system.1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriatenessof the standard in view of a particular bone plate and its potential application.1.4 This document in

7、cludes the following test methods used in determining the following bone plate mechanical performancecharacteristics. characteristics:1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone PlatesAnnex A1., and1.4.2 Standard Test Method for Determining the Bending Fatigue Propertie

8、s Of Metallic Bone PlatesAnnex A2.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test usingall of the de

9、scribed methods. Instead, the user should only select test methods that are appropriate for a particular device design.In most instances, only a subset of the herein described test methods will be required.1.7 This standard does not purport to address all of the safety concerns, if any, associated w

10、ith its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E122 Practice for Calculating Sample Size to Estimate, With Specifie

11、d Precision, the Average for a Characteristic of a Lot orProcessF67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS

12、R30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)1 This specification and test method is under the jurisdiction of ASTM Committee F04 on Medical

13、and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved Nov. 1, 2008Nov. 1, 2014. Published November 2008January 2014. Originally approved in 1973. Last previous edition approved in 20032008as F382 99 (2008)(2003)1. DOI: 10

14、.1520/F0382-99R08E01.10.1520/F0382-14.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an

15、 ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. I

16、n all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra

17、Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Sur

18、gical Implants(UNS S31673)F543 Specification and Test Methods for Metallic Medical Bone ScrewsF565 Practice for Care and Handling of Orthopedic Implants and InstrumentsF620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta ConditionF621 Specification for Stainles

19、s Steel Forgings for Surgical ImplantsF983 Practice for Permanent Marking of Orthopaedic Implant ComponentsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium13 Nickel5 Manga

20、nese2.5 Molybdenum StainlessSteel Alloy Bar and Wire for Surgical Implants (UNS S20910)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applicatio

21、ns (UNS R58130)2.2 ISO Standard:3ISO 9585 Implants for SurgeryDetermination of Bending Strength and Stiffness of Bone PlatesFDIS 14602ISO 14602 Non-active surgical implantsImplants for Osteosynthesis particular requirements.3. Terminology3.1 DefinitionsGeometric:3.1.1 auto compressiona type of bone

22、plate that by its design can generate a compressive force between adjacent unconnectedbone fragments through the use of one or more ramped holes or another type of slot geometry. This ramp or slot geometry contactsthe underside of the screw head, and induces compressive force as the screw is inserte

23、d and tightened to the bone plate.3.1.2 bone platea metallic device with two or more holes or slot(s), or both, and a cross section that consists of at least twodimensions (width and thickness) which generally are not the same in magnitude. The device is intended to provide alignment andfixation of

24、two or more bone sections, primarily by spanning the fracture or defect.The device is typically fixed to the bone throughthe use of bone screws or cerclage wire. A partial list of general types of bone plates is given in Section 4.1.3.1.3 bone plate length, L (mm)the linear dimension of the bone pla

25、te measured along the longitudinal axis as illustrated inFig. 2.3.1.4 bone plate thickness, b (mm)the linear dimension of the bone plate measured parallel to the screw hole axis as showninFigs. Fig. 1a,1a, 1b, and Fig. 2.2. For a bone plate with a crescent section, the thickness is measured at the t

26、hickest point alongthe section.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.FIG. 1 Bone Plate Cross-sectionsF382 1423.1.5 bone plate width, w (mm)the linear dimension of the bone plate measured perpendicular to both

27、the length and thicknessaxes as shown in Fig. 2.3.1.6 contouringthe manipulation and bending of a bone plate, 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

28、 axis of the bone plate) where the thicknessis not constant along the section. Typically the section is thickest along the bone plates centerline and tapers to a smaller thicknessat the bone plates edges (see Fig. 1b).3.1.8 uniform widthreferring to a bone plate where the width is constant along the

29、 bone plates length.3.2 DefinitionsMechanical/Structural:3.2.1 bending stiffness, K (N/mm) of a bone plate, the maximum slope of the linear elastic portion of the load versus load-pointdisplacement curve for a bone plate when tested according to the test method of Annex A1.3.2.2 bending strength (N-

30、m) of a bone plate, the bending moment necessary to produce a 0.2 % offset displacement in thebone plate when tested as described in Annex A1.3.2.3 bending structural stiffness, El (N-m2)of a bone plate, the bone plates normalized effective bending stiffness that takesinto consideration the effects

31、of the test setups configuration when tested according to the method described in Annex A1.3.2.4 fatigue life, nThethe number of loading cycles of a specified character that a given specimen sustains before failure ofa specified nature occurs.3.2.5 fatigue strength at N cyclesAn estimate of the cycl

32、ic forcing parameter (for example, load, moment, torque, stress, andso on) at a given load ratio, for which 50 % of the specimens within a given sample population would be expected to survive Nloading cycles.FIG. 2 Bone Plate DimensionsF382 1434. Classification4.1 Bone plates used in general orthopa

33、edic surgery can be categorized into general types according to the followingclassifications. classifications:4.1.1 Cloverleaf Platecloverleaf plateA a bone plate that has one three-lobed end which contains screw holes.4.1.2 Cobra Head Platecobra head plateA a bone plate that has one flared triangul

34、ar or trapezoidal end which containsmultiple screw holes or slots, or both. This type of bone plate is often used for hip arthrodesis.4.1.3 Reconstruction Platereconstruction plateAa bone plate that does not have a uniform width, but usually has a smallercross-section between the screw holes or slot

35、s. The reduced cross-section between screw holes/slots facilitates contouring the boneplate in several planes. Reconstruction plates are often used in fractures of the pelvis and acetabulum.4.1.4 Straight Platestraight plateAa bone plate with uniform width and a straight longitudinal axis. Straight

36、plates are oftenused for fractures of the diaphysisdiaphyses of long bones.4.1.5 Tubular Platetubular plateAa bone plate whose cross-section resembles a portion of a tube, and which has a constantthickness or a crescent section. Tubular plates are often used for fractures of the smaller long bones (

37、that is, radius, ulna, fibula).5. Marking, Packaging, Labeling, and Handling5.1 Dimensions of bone plates should be designated by the standard definitions given in Section 3.1.5.2 Bone plates shall be marked using a method specified in accordance with either Practice F983 or ISO 14602FDIS 14602ISO 1

38、4602.5.3 Markings on bone plates shall identify the manufacturer or distributor and shall be madelocated away from the most highlystressed areas, where possible.5.4 Packaging shall be adequate to protect the bone plates during shipment.5.5 Package labeling for bone plates shall include when possible

39、 the following information:5.5.1 Manufacturer and Product Name,product name;5.5.2 Catalog number,number;5.5.3 Lot or serial number,number;5.5.4 Material and, where applicable, its associated ASTM specification designation number,number;5.5.5 Number of screw holes,holes;5.5.6 Bone plate width,width;5

40、.5.7 Bone plate length,length;5.5.8 Bone plate thickness,thickness; and5.5.9 ASTM specification designation number.5.6 Bone plates should be cared for and handled in accordance with Practice F565, as appropriate.6. Materials6.1 All bone plates made of materials which have anASTM committee F04 standa

41、rd designation shall meet those requirementsgiven in the ASTM standards. A majority of materials having ASTM specifications can be found in the list of referenced ASTMstandards of Section 2.1.6.2 Bone plates of forged Specification F136 shall meet the requirements of Specification F620.6.3 Bone plat

42、es of forged Specification F138 shall meet the requirements of Specification F621.7. General Requirements and Performance Considerations7.1 geometric considerationsGeometric ConsiderationsboneBone plates that are intended to be used with bone screws shallhave design features (screw holes or slots) t

43、hat conform or appropriately fit the corresponding bone screw.7.2 bending propertiesPending PropertiesThis is a critical characteristic of bone plates for orthopedic applications since thebone plate provides the primary means of stabilizing the bone fragments.Additionally, the bending stiffness of t

44、he bone plate maydirectly affect the rate and abilitycompleteness of healing.7.2.1 The relevant bending properties (bending stiffness, bending structural stiffness, and bending strength) shall be determinedusing the standard test method of Annex A1.7.2.2 Determine the The relevant bending fatigue pr

45、operties according to shall be determined in accordance with the methodsdescribed in Annex A2.8. Keywords8.1 bend testingsurgical implants; fatigue test; bone plate; orthopedic medical devicesbone plates; surgical devices; testmethodssurgical implantsF382 144ANNEXESA1. STANDARD TEST METHOD FOR SINGL

46、E CYCLE BEND TESTING OF METALLIC BONE PLATES1A1.1 Scope:A1.1.1 This test method describes methods for single cycle bend testing in order to determine the intrinsic, structural propertiesof metallic bone plates. The test method measures the bending stiffness, bending structural stiffness, and bending

47、 strength of boneplates.A1.1.2 This test method is intended to provide a means of mechanically to characterize mechanically different bone plate designs.It is not the intention of this standard to define levels of performance for bone plates as insufficient knowledge is available to predictthe conse

48、quences of the use of particular bone plate designs.A1.1.3 This test method is intended to evaluate the bending strength, bending structural stiffness, or the bending stiffness of thebone plate, and may not be appropriate for all situations. When the structurally critical region of the bone plate is

49、 shown to belocated through a non-uniform region of the bone plate (i.e., a peri-prosthetic, contoured plate), it may be necessary to evaluatethe bending strength, bending structural stiffness, or bending stiffness of this region of the bone plate using a different test method.This is because it may not be physically possible to fit the non-uniform region between the loading rollers of a four-point bendtest. Structurally critical regions may be identified through such methods as hand calculations, Finite ElementAnalysis, etc. Sc