ASTM F382-2017 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 14F382 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.Anumber i

2、n parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgicalinternal fixation of the

3、skeletal system. The standard establishes consistent methods to classify and define the geometric andperformance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material;labeling and handling requirements; and standard test methods for mea

4、suring performance related mechanical characteristicsdetermined 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 performance or case-specific clinical performance for bone plates,as insufficient knowledge is available to predic

5、t 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 for bone plates used in the surgicalinternal fixation of the skeletal system.1.3 This document may not be appropr

6、iate 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 includes the following test methods used in determining the following bone plate mechanical performancecharacteri

7、stics: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 Properties Of Metallic Bone PlatesAnnex A2.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement

8、 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 described methods. Instead, the user should only select test methods that are appropriate for a particular device design.In most in

9、stances, 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 with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health and healthenviro

10、nmental practices and determine theapplicability of regulatory limitations prior to use.1.8 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, G

11、uides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot orProcessF67 Specification

12、 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 (UNSR30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical Impl

13、ants1 This specification and test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved Nov. 1, 2014Sept. 1, 2017. Published January 2014October 2017. Orig

14、inally approved in 1973. Last previous edition approved in 20082014 asF382 99 (2008)F382 14.1. DOI: 10.1520/F0382-14.10.1520/F0382-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume infor

15、mation, refer to the standards Document Summary page on the ASTM website.This document is not an 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 de

16、pict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In 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 1

17、9428-2959. United States1F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specificati

18、on 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 Surgical Implants(UNS S31673)F543 Specification and Test Methods for Metallic Medical Bo

19、ne 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 Stainless Steel Forgings for Surgical ImplantsF983 Practice for Permanent Marking of Orthopae

20、dic Implant ComponentsF1295F2503 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentF1314 Specification for Wrought Nitrogen Strengthened 22 Chro

21、mium13 Nickel5 Manganese2.5 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 Surgica

22、l Implant Applications (UNS R58130)2.2 ISO Standard:3ISO 9585 Implants for SurgeryDetermination of Bending Strength and Stiffness of Bone PlatesISO 14602 Non-active surgical implantsImplants for Osteosynthesis particular requirements.3. Terminology3.1 DefinitionsGeometric:3.1.1 auto compressiona typ

23、e of bone 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

24、is inserted 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 andfi

25、xation of 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 th

26、e bone plate measured along the longitudinal axis as illustrated inFig. 2.3 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 1723.1.4 bone plate thickness, b (mm)the linear dimension of

27、 the bone plate measured parallel to the screw hole axis as shownFigs. 1a, 1b, and 2. For a bone plate with a crescent section, the thickness is measured at the thickest point along the section.3.1.5 bone plate width, w (mm)the linear dimension of the bone plate measured perpendicular to both the le

28、ngth 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 axis

29、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 bone

30、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-m) of

31、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 of the

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

33、g 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 1734. Classification4.1 Bone plates used in general orthopaedic surg

34、ery can be categorized into general types according to the followingclassifications: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 flared triangular or trapezoidal end which contains multiple screw holes orsl

35、ots, or both. This type of bone plate is often used for hip arthrodesis.4.1.3 Reconstruction PlateA bone plate that does not have a uniform width, but usually has a smaller cross-section betweenthe screw holes or slots.The reduced cross-section between screw holes/slots facilitates contouring the bo

36、ne plate in several planes.Reconstruction plates are often used in fractures of the pelvis and acetabulum.4.1.4 Straight PlateA bone plate with uniform width and a straight longitudinal axis. Straight plates are often used forfractures of the diaphyses of long bones.4.1.5 Tubular PlateA bone plate w

37、hose cross-section resembles a portion of a tube, and which has a constant thickness or acrescent section. Tubular plates are often used for fractures of the smaller long bones (that is, radius, ulna, fibula).5. Marking, Packaging, Labeling, and Handling5.1 Dimensions of bone plates should be design

38、ated 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 14602ISO 14602.ISO 14602.5.3 Markings on bone plates shall identify the manufacturer or distributor and shall be located away from the most hi

39、ghlystressed 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 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

40、and, where applicable, its associated ASTM specification 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 accordance with Practic

41、e F565, as appropriate.5.7 Consider Practice F2503 to identify potential hazards produced by interactions between the device and the MR environmentand for terms that may be used to label the device for safety in the MR environment.6. Materials6.1 All bone plates made of materials which have anASTM c

42、ommittee F04 standard 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 2.1.6.1 Bone plates of forged Specificationshall be fabricated F136 shall meet the requiremen

43、ts of Specificationfrom a metallicmaterial intended for surgical implant applications. In addition, the materials shall be biocompatible for the intended application.Materials should be chosen based on the design requirements of the F620.particular device. ASTM committee F04.12 maintainsa number of

44、metallic material specifications suitable for surgical implant applications.6.3 Bone plates of forged Specification F138 shall meet the requirements of Specification F621.7. General Requirements and Performance Considerations7.1 Geometric ConsiderationsBone plates that are intended to be used with b

45、one screws shall have design features (screwholes or slots) that conform or appropriately fit the corresponding bone screw.7.2 Pending PropertiesThis is a critical characteristic of bone plates for orthopedic applications since the bone plate providesthe primary means of stabilizing the bone fragmen

46、ts. Additionally, the bending stiffness of the bone plate may directly affect therate and completeness 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 The rele

47、vant bending fatigue properties shall be determined in accordance with the methods described in Annex A2.F382 1748. Keywords8.1 bend testingsurgical implants; fatigue test; bone plate; orthopedic medical devicesbone plates; surgical devices; testmethodssurgical implantsANNEXESA1. STANDARD TEST METHO

48、D FOR SINGLE 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,

49、and bending strength of boneplates.A1.1.2 This test method is intended to provide a means to characterize mechanically different bone plate designs. It is not theintention of this standard to define levels of performance for bone plates as insufficient knowledge is available to predict theconsequences 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