1、Designation: F384 12Standard 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 revision, the year
2、 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 the surgicalintern
3、al 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 requirements, andsta
4、ndard 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 or case-specific clinical performance for angleddevices, as insufficient k
5、nowledge 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 This standard may no
6、t 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 devices without a s
7、ideplate.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 Annex A1).1.4.2 Standa
8、rd 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 no ISO standard th
9、at 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 Precision, the Average fo
10、r 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 Specification for
11、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-14Nickel-2.5Molybde
12、num 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 BonePlatesF565 Practice for Care and Handling of Ortho
13、pedic Im-plants and InstrumentsF620 Specification for TitaniumAlloy Forgings for SurgicalImplants in the Alpha Plus Beta ConditionF621 Specification for Stainless Steel Forgings for SurgicalImplantsF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1295 Specification for Wrought
14、Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)1These 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 editio
15、n approved May 15, 2012. Published June 2012. Originallyapproved in 1973. Last previous edition approved in 2011 as F384 06 (2011).DOI: 10.1520/F0384-12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMSt
16、andards 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.F1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 Mo
17、lybdenumStainless 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-13Niobium-13Zirconium Alloy for Surgical Implant Applications(UNS R5813
18、0)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 Asymmetrical Thread andSpherical Under SurfaceISO 9268 Implants for Sur
19、geryMetal 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 forOsteosynthesisParticular Requirements3. Terminology3.1 Definitions: Geomet
20、ric3.1.1 angle (degree)defined at either the barrel/sideplateor blade/sideplate junction (see Fig. 1 and Fig. 2).3.1.2 angled devicean orthopaedic device for the fixationof fractures in the metaphyseal areas of long bones that has acomponent aligned at an angle to the long axis of the bone.3.1.3 bar
21、relthe portion of an angled device which cap-tures the lag screw (see Fig. 1).3.1.4 barrel length, LBR(mm) the distance from the freeend of the barrel to the interior vertex of the barrel/sideplatejunction (see Fig. 1).3.1.5 bladethe portion of an angled device which trans-mits the off axis loading
22、of the anatomical loading condition tothe sideplate portion of the angled device (see Fig. 2).3.1.6 blade length, LBD(mm)the distance from the freeend of the blade to the interior vertex of the blade/sideplatejunction (see Fig. 2).3.1.7 lag screwthat component of a compression hipscrew angled device
23、 which is threaded into the metaphysis andtransmits the off axis load to the sideplate through the barrel(see Fig. 1).3.1.8 lag screw length (mm)the straight line distancemeasured between the proximal and distal ends of the lagscrew (see Fig. 1).3.1.9 sideplatethat portion of the angle device genera
24、llyaligned with the long axis of the bone which attaches to thebone via bone screws (see Fig. 1 and Fig. 2).3.1.10 sideplate length, L (mm)the distance from the freeend of the sideplate to the interior vertex of the barrel/sideplatejunction or to the interior vertex of the blade/sideplate junction(s
25、ee Fig. 1 and Fig. 2).3.1.11 sideplate thickness, b (mm)the linear dimension ofthe sideplate measured parallel to the screw hole axis (see Fig.1 and Fig. 2). For a sideplate with a crescent section, thethickness is measured at the thickest point along the section.3.1.12 sideplate width, w (mm)the li
26、near dimension of thesideplate measured perpendicular to both the length andthickness axes (see Fig. 1 and Fig. 2).3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.FIG. 1 Diagram Illustrating Compression Hip Screw Angled D
27、evicesFIG. 2 Diagram Illustrating Blade Plate Angled DevicesF384 1223.1.13 thread diameter (mm)the maximum outer diameterof the lag screw threads (see Fig. 1).3.1.14 thread length (mm)the straight line distance mea-sured between the tip and thread runout positions of the screw(see Fig. 1).3.2 Defini
28、tions: Mechanical/Structure:3.2.1 bending strength (N-m) of the sideplate, the bendingmoment necessary to produce a 0.2 % offset displacement inthe sideplate when tested as described in Annex A1 ofSpecification and Test Method F382.3.2.2 bending structural stiffness, Ele(N-m2)of the side-plate, the
29、normalized effective bending stiffness of the side-plate that takes into consideration the test setup configurationwhen tested according to the method described in Annex A1.3.2.3 compression bending stiffness, (K) (N/m)of a device,the maximum slope of the linear elastic portion of the loadversus dis
30、placement curve, when tested as described in AnnexA1.3.2.4 compression bending strength (N/m)of a device, thebending moment necessary to produce a 0.2 % offset displace-ment in the device when tested as described in Annex A1.3.2.5 fatigue strength at N cyclesan estimate of the cyclicforcing paramete
31、r (for example, load, moment, torque, stress,etc.) at a given load ratio, for which 50 % of the specimenswithin a given sample population would be expected to surviveN loading cycles.3.2.6 fatigue life, Nthe number of loading cycles of aspecified character that a given specimen sustains beforefailur
32、e of a specified nature occurs.4. Classification4.1 Angled devices used in general orthopedic surgeryrepresents a subset of bone plates. Angled devices are mainlyused in the treatment of fractures in the metaphyseal areas oflong bones. Angled devices can be categorized into generaltypes according to
33、 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 relative to the sideplate; this component oftenis shaped like a blade to achieve fixation into the metaphysis(see Fig. 2), and4.1.2 Co
34、mpression Hip Screwan angled device where thecomponent of the device which is oriented at an angle from thelong axis of the bone is free to translate relative to the sideplatethrough a barrel; this component often achieves fixation intothe metaphysis through the use of deep threads (see Fig. 1).5. M
35、arking, 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 using a method speci-fied in accordance with either Practice F983 or ISO 14602.5.3 Markings on angled devices shall identify the ma
36、nufac-ture or distributor and shall be situated away from the mosthighly stressed areas, where possible.5.4 Packaging shall be adequate to protect the angled deviceduring shipment.5.5 Package labeling for angled devices shall include whenpossible the following information:5.5.1 Manufacturer and prod
37、uct 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 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 Sidep
38、late 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 with Practice F565, as appropriate.6. Materials6.1 All angled devices made of materials which can bepurchased to an ASTM speci
39、fication shall meet those require-ments given in the ASTM specification. Such specificationinclude: F67, F75, F90, F139, F1295, F1314, F1472, andF1713.6.2 Angled devices of forged Specification F136 shall meetthe requirements of Specification F620.6.3 Angled devices of forged Specification F138 shal
40、l meetthe requirements of Specification F621.7. General Requirements and PerformanceConsiderations7.1 Geometric ConsiderationsFor angled devices that areintended to be used with bone screws that conform to ISO 5835or ISO 9268, the screw holes shall correspond to the dimen-sions and tolerances of ISO
41、 5836 or ISO 9269, respectively.7.2 Bending PropertiesBending properties are a criticalcharacteristic of angled devices for orthopedic applicationssince the plate provides the primary means of stabilizing thebone fragments. Additionally, the bending stiffness of theangled device may directly affect
42、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 determined using Annex A1.7.2.2 The relevant bending properties (bending stiffness,bending structural stiffness and bending strengt
43、h) of thesideplate shall be determined using the Annex A1 of Specifi-cation and Test Method F382.7.2.3 Determine the relevant angled device bending fatigueproperties according to the methods described in Annex A2.7.2.4 Determine the relevant side plate bending fatigueproperties according to the meth
44、ods described in Annex A1 ofSpecification and Test Method F382.8. Keywords8.1 angled devices; bend testing; blade plate; compressionhip screw; fatigue test; orthopedic medical devices; surgicaldevices; surgical implantsF384 123ANNEXES(Mandatory Information)A1. STANDARD TEST METHOD FOR SINGLE CYCLE C
45、OMPRESSION BEND TESTING OF METALLIC ANGLEDORTHOPEDIC FRACTURE FIXATION DEVICESA1.1 ScopeA1.1.1 This test method describes methods for single cyclebend testing for determining intrinsic, structural properties ofmetallic angled orthopedic fracture fixation devices. The testmethod measures compression
46、bending stiffness and compres-sion bending strength of the angled device.A1.1.2 This test method is intended to provide a means tomechanically characterize different angled device designs. It isnot the intention of this test method to define levels ofperformance for angled devices, as these characte
47、ristics aredriven by patient-specific clinical requirements.A1.1.3 This test method is designed to provide flexibility inthe testing configuration so that a range of clinical failuremodes for the angled fixation devices (for example, sideplate,lag screw, and barrel fractures) can be evaluated.A1.1.4
48、 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 address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appr
49、o-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 Practices 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 (mm)permanentdeformation equal to 0.2 % of the lever arm length (see pointBinFig. A1.1).A1.3.1.2 compression bending stiffness, K (N/m)of anangled device, the maximum s
