1、Designation: F384 06 (Reapproved 2011)Standard Specifications and Test Methods forMetallic Angled Orthopedic Fracture Fixation Devices1This standard is issued under the fixed designation F384; the number immediately following the designation indicates the year of originaladoption or, in the case of
2、revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 These specifications and test methods provide a com-prehensive reference for angled devices used in
3、the surgicalinternal fixation of the skeletal system. This standard estab-lishes consistent methods to classify and define the geometricand performance characteristics of angled devices. This stan-dard also presents a catalog of standard specifications thatspecify material, labeling, and handling re
4、quirements, andstandard test methods for measuring performance relatedmechanical characteristics determined to be important to the invivo performance of angled devices.1.2 It is not the intention of this standard to define levels ofperformance of case-specific clinical performance for angleddevices,
5、 as insufficient knowledge is available to predict theconsequences of their use in individual patients for specificactivities of daily living. Futhermore, this standard does notdescribe or specify specific designs for angled devices used inthe surgical internal fixation of the skeletal system.1.3 Th
6、is standard may not be appropriate for all types ofangled devices. The user is cautioned to consider the appro-priateness of this standard in view of a particular angled deviceand its potential application.NOTE 1This standard is not intended to address intramedullary hipscrew nails or other angled d
7、evices without a sideplate.1.4 This standard includes the following test methods usedin determining the following angled device mechanical perfor-mance characteristics:1.4.1 Standard test method for single cycle compressionbend testing of metallic angled orthopedic fracture fixationdevices (see Anne
8、x A1).1.4.2 Standard test method for determining the bendingfatigue properties of metallic angled orthopedic fracture fixa-tion devices (see Annex A2).1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.NOTE 2There is currently
9、no ISO standard that is either similar toequivalent to this standard.2. Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE8 Test Methods for Tension Testing of Metallic MaterialsE122 Practice for Calculating Sample Size to Estimate,With Specified Precisi
10、on, the Average for a Characteristicof a Lot or ProcessF67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F90
11、Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F138 Specification for Wrought 18Chromium-1
12、4Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgi-cal Implants (UNS S31673)F382 Specification and Test Method for Metallic BonePlatesF543 Specification and Tes
13、t Methods for Metallic MedicalBone ScrewsF565 Practice for Care and Handling of Orthopedic Im-plants and InstrumentsF620 Specification for Alpha Plus Beta Titanium AlloyForgings for Surgical ImplantsF621 Specification for Stainless Steel Forgings for SurgicalImplantsF983 Practice for Permanent Marki
14、ng of Orthopaedic Im-plant Components1These specifications and test methods are under the jurisdiction of ASTMCommittee F04 on Medical and Surgical Materials and Devices and are the directresponsibility of Subcommittee F04.21 on Osteosynthesis.Current edition approved June 1, 2011. Published July 20
15、11. Originally approvedin 1973. Last previous edition approved in 2006 as F384 061. DOI: 10.1520/F0384-06R11.2For 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 sta
16、ndards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F1314 Specification for Wr
17、ought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F1713 Specification for Wrought Titanium-13Ni
18、obium-13Zirconium Alloy for Surgical Implant Applications(UNS R58130)2.2 ISO Standards:3ISO 5835 Implants for SurgeryMetal Bone Screws withHexagonal Drive ConnectionSpherical Under Surfaceof Head, Asymmetrical ThreadISO 5836 Implants for SurgeryMetal Bone PlatesHolesCorresponding to Screws with Asym
19、metrical Thread andSpherical Under SurfaceISO 9268 Implants for SurgeryMetal Bone Screws withConical Under-Surface of HeadDimensionsISO 9269 Implants for SurgeryMetal Bone PlatesHolesand Slots Corresponding to Screws with Conical Under-SurfaceISO 14602 Non-active Surgical ImplantsImplants forOsteosy
20、nthesisParticular Requirements3. Terminology3.1 Definitions: Geometric3.1.1 angle, ndefined at either the barrel/sideplate orblade/sideplate junction (see Fig. 1 and Fig. 2).3.1.2 angled device, na class of orthopedic devices for thefixation of fractures in the methaphyseal areas of long bonesthat h
21、as a component aligned at an angle to the bones longaxis.3.1.3 barrel, nthe portion of an angled device whichcaptures the lag screw (see Fig. 1).3.1.4 barrel length, LBR, n the distance from the free endof the barrel to the interior vertex of the barrel/sideplatejunction (see Fig. 1).3.1.5 blade, nt
22、he portion of an angled device whichtransmits the off axis loading of the anatomical loadingcondition to the sideplate portion of the angled device (see Fig.2).3.1.6 blade length, LBD, nthe distance from the free endof the blade to the interior vertex of the blade/sideplate junction(see Fig. 2).3.1.
23、7 lag screw, nthat component of a compression hipscrew angled device which is threaded into the metaphyses andtransmits the off axis load to the sideplate through the barrel(see Fig. 1).3.1.8 lag screw length, nthe straight line distance mea-sured between the proximal and distal ends of the lag scre
24、w(see Fig. 1).3.1.9 sideplate, nthat portion of the angle device gener-ally aligned with the bones long axis which attaches to thebone via bone screws (see Fig. 1 and Fig. 2).3.1.10 sideplate length, L, nthe distance from the free endof the sideplate to the interior vertex of the barrel/sideplatejun
25、ction, shown in Fig. 1 and Fig. 2.3.1.11 sideplate thickness, b, nthe thickness of the side-plate as shown in Fig. 1 and Fig. 2.3.1.12 sideplate width, w, nthe width of the sideplate asshown in Fig. 1 and Fig. 2.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor,
26、New York, NY 10036, http:/www.ansi.org.FIG. 1 Diagram Illustrating Compression Hip Screw Angled DevicesFIG. 2 Diagram Illustrating Blade Plate Angled DevicesF384 06 (2011)23.1.13 thread diameter, nthe maximum outside diameterof the lag screw (see Fig. 1).3.1.14 thread length, nthe straight line dist
27、ance measuredbetween the tip and thread runout positions of the screw (seeFig. 1).3.2 Definitions: Mechanical/Structure:3.2.1 bending strength, n of the sideplate, the bendingmoment necessary to produce a 0.2 % offset displacement inthe sideplate when tested as described in Annex A1 ofSpecification
28、and Test Methods F382.3.2.2 bending structural stiffness, Ele, nof the sideplate,the sideplates normalized effective bending stiffness that takesinto consideration the effects of the test setups configurationwhen tested according to the method described inAnnexA1 ofSpecification and Test Methods F38
29、2.3.2.3 compression bending stiffness, (K), nof a device, themaximum slope of the linear elastic portion of the load versusdisplacement curve, when tested as described in Annex A1.3.2.4 compression bending strength, nof a device, thebending moment necessary to produce a 0.2 % offset displace-ment in
30、 the device when tested as described in Annex A1.3.2.5 fatigue strength at N cycles, nan estimate of thecyclic forcing parameter, for example, load, moment, torque,stress, etc., at a given load ratio, for which 50 % of thespecimens within a given sample population would be ex-pected to survive N loa
31、ding cycles.3.2.6 fatigue life, N, nthe number of loading cycles of aspecified character that a given specimen sustains beforefailure of a specified nature occurs.4. Classification4.1 Angled devices used in general orthopedic surgeryrepresent a subset of bone plates. Angled devices are mainlyused in
32、 the treatment of fractures in the metaphyseal areas oflong bones. Angled devices can be categorized into generaltypes according to the following classifications:4.1.1 Blade Platean angled device where the componentof the device that is oriented at an angle from the long axis ofthe bone is fixed rel
33、ative to the sideplate; this component oftenis shaped like a blade to achieve fixation into the metaphyses(see Fig. 2), and4.1.2 Compression Hip Screwan angled device where thecomponent of the device which is oriented at a angle from thelong axis of the bone is free to translate relative to the side
34、platethrough a barrel; this component often achieves fixation intothe metaphyses through the use of deep threads (see Fig. 1).5. Marking, Packaging, Labeling and Handling5.1 Dimensions of angled devices should be designated bythe standard definitions given in 3.1.5.2 Angled devices shall be marked u
35、sing a method speci-fied in accordance with either Practice F983 or ISO 14602.5.3 Markings on angled devices shall identify the manufac-ture or distributor and shall be made away from the most highlystressed areas, where possible.5.4 Packaging shall be adequate to protect the angled deviceduring shi
36、pment.5.5 Package labeling for angled devices 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,5.5.5 Device angle, between
37、 the sideplate and the barrel(blade)5.5.6 Barrel (blade) length,5.5.7 Number of screw holes,5.5.8 Sideplate width,5.5.9 Sideplate length,5.5.10 Sideplate thickness,5.5.11 Screw hole size, and5.5.12 ASTM specification designation number.5.6 Bone plates should be cared for and handled in accor-dance w
38、ith Practice F565, as appropriate.6. Materials6.1 All angled devices made of materials which can bepurchased to an ASTM specification shall meet those require-ments given in the ASTM specification. Such specificationinclude: F67, F75, F90, F139, F543, F1295, F1314, F1472, andF1713.6.2 Angled devices
39、 of forged Specification F136 shall meetthe requirements of Specification F620.6.3 Angled devices of forged Specification F138 shall meetthe requirements of Specification F621.7. General Requirements and PerformanceConsiderations7.1 Geometric ConsiderationsFor angled devices that areintended to be u
40、sed with bone screws that conform to ISO 5835or ISO 9268, the screw holes shall correspond to the dimen-sions and tolerances of ISO 5836 or ISO 9269, respectively.7.2 Bending PropertiesBending properties are a criticalcharacteristic of angled devices for orthopedic applicationssince the plate provid
41、es the primary means of stabilizing thebone fragments. Additionally, the bending stiffness of theangled device may directly affect the rate and ability ofhealing.7.2.1 The relevant compression bending properties (com-pression bending stiffness and compression bending strength)of the device shall be
42、determined using Annex A1.7.2.2 The relevant bending properties (bending stiffness,bending structural stiffness and bending strength) of thesideplate shall be determined using the Annex A1 of Specifi-cation and Test Methods F382.7.2.3 Determine the relevant angled device bending fatigueproperties ac
43、cording to the methods described in Annex A2.7.2.4 Determine the relevant side plate bending fatigueproperties according to the methods described in Annex A2 ofSpecification and Test Methods F382.8. Keywords8.1 angled devices; bend testing; blade plate; compressionhip screw; fatigue test; orthopedic
44、 medical devices; surgicaldevices; surgical implantsF384 06 (2011)3ANNEXES(Mandatory Information)A1. STANDARD TEST METHOD FOR SINGLE CYCLE COMPRESSION BEND TESTING OF METALLIC ANGLEDORTHOPEDIC FRACTURE FIXATION DEVICESA1.1 ScopeA1.1.1 This test method describes methods for single cyclebend testing f
45、or determining intrinsic, structural properties ofmetallic angled orthopedic fracture fixation devices. The testmethod measures the angled devices compression bendingstiffness and compression bending strength.A1.1.2 This test method is intended to provide a means tomechanically characterize differen
46、t angled device designs. It isnot the intention of this test method to define levels ofperformance for angled devices, as these characteristics aredriven by patient-specific clinical requirements.A1.1.3 This test method is designed to provide flexibility inthe testing configuration so that a range o
47、f clinical failuremodes for the angled fixation devices (for example, sideplate,lag screw, and barrel fractures) can be evaluated.A1.1.4 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.A1.1.5 This standard does not purport to ad
48、dress all of thesafety concerns, if any, associated with its use. It is theresponsibility 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.A1.2 Referenced Documents2A1.2.1 ASTM Standards:E4 Prac
49、tices for Load Verification of Testing MachinesE122 Practice for Choice of Sample Size to Estimate theAverage Quality of a Lot or ProcessA1.3 TerminologyA1.3.1 Definitions:A1.3.1.1 0.2 % offset displacement, q, npermanent defor-mation (mm) equal to 0.2 % of the lever arm length (see pointBinFig. A1.1).A1.3.1.2 compression bending stiffness, K, nof an angleddevice, the maximum slope (N/m) of the linear elastic portionof the load versus displacement curve, when tested as de-scribed in A1.8. (See the slope of line 0m in Fig. A1.1).A1
