1、Designation: F 384 06Standard Specifications and Test Methods forMetallic Angled Orthopedic Fracture Fixation Devices1This standard is issued under the fixed designation F 384; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the ye
2、ar of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 surgica
3、linternal 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,
4、 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, as insuffi
5、cient 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 This standard
6、 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 devices with
7、out 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 Annex A1).1.4.2
8、 Standard test method for determining the bendingfatigue properties of metallic angled orthopedic fracture fixa-tion devices (see Annex A2).1.5 Unless otherwise indicated, the values stated in SI unitsshall be regarded as the standard.NOTE 2There is currently no ISO standard that is either similar t
9、oequivalent to this standard.2. Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE8 Test Methods for Tension Testing of Metallic MaterialsE 122 Practice for Calculating Sample Size to Estimate,With a Specified Tolerable Error, the Average for aCharacteri
10、stic of 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 Wrought Coba
11、lt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainl
12、ess Steel Bar and Wire for SurgicalImplants (UNS S31673)F 139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgi-cal Implants (UNS S31673)F 382 Specification and Test Method for Metallic BonePlatesF 543 Specification and Test Methods for Metallic Me
13、dicalBone ScrewsF 565 Practice for Care and Handling of Orthopedic Im-plants and InstrumentsF 620 Specification for Alpha Plus Beta Titanium AlloyForgings for Surgical Implants1These specifications and test methods are under the jurisdiction of ASTMCommittee F04 on Medical and Surgical Materials and
14、 Devices and are the directresponsibility of Subcommittee F04.21 on Osteosynthesis.Current edition approved Jan. 15, 2006. Published February 2006. Originallyapproved in 1973. Last previous edition approved in 2000 as F 384 00.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orc
15、ontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards 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.F 621 Specification
16、 for Stainless Steel Forgings for SurgicalImplantsF 983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF 1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 1
17、3 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F 1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical I
18、mplant 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 Asymmetrical Thread andSpherical Under Sur
19、faceISO 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 forOsteosynthesisParticular Requirements3. Termi
20、nology3.1 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 has a component aligned at an angle to
21、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, nthe portion of an angled device whichtr
22、ansmits 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).3.1.7 lag screw, nthat component of a comp
23、ression 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 screw(see Fig. 1).3.1.9 sideplate, nthat p
24、ortion 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).3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.FIG. 1 Diagram Illustrating Compression Hip Screw Angled
25、 DevicesFIG. 2 Diagram Illustrating Blade Plate Angled DevicesF3840623.1.10 sideplate length, L, nthe distance from the free endof the sideplate to the interior vertex of the barrel/sideplatejunction, shown in Fig. 1 and Fig. 2.3.1.11 sideplate thickness, b, nthe thickness of the side-plate as shown
26、 in Fig. 1 and Fig. 2.3.1.12 sideplate width, w, nthe width of the sideplate asshown in Fig. 1 and Fig. 2.3.1.13 thread diameter, nthe maximum outside diameterof the lag screw (see Fig. 1).3.1.14 thread length, nthe straight line distance measuredbetween the tip and thread runout positions of the sc
27、rew (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 and Test Methods F 382.3.2.2 bending structural stiffness, Ele, no
28、f 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 F 382.3.2.3 compression bending stiffness, (K), nof a device, themax
29、imum 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 the device when tested as described in Annex A1.3.2.5 fatigue s
30、trength 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 loading cycles.3.2.6 fatigue life, N, nthe number of loading cycles
31、 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 the treatment of fractures in the metaphyseal areas oflong bone
32、s. 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 relative to the sideplate; this component oftenis shaped like a bla
33、de 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 sideplatethrough a barrel; this component often achieves fixation in
34、tothe 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 using a method speci-fied in accordance with either Practice F 98
35、3 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 shipment.5.5 Package labeling for angled devices shall include whe
36、npossible 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 the sideplate and the barrel(blade)5.5.6 Barrel (blade) length
37、,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 with Practice F 565, as appropriate.6. Materials6.1 All angled d
38、evices 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, F 139, F 543, F 1295, F 1314,F 1472, and F 1713.6.2 Angled devices of forged Specification F 136 shall meetthe requirement
39、s of Specification F 620.6.3 Angled devices of forged Specification F 138 shall meetthe requirements of Specification F 621.7. General Requirements and PerformanceConsiderations7.1 Geometric ConsiderationsFor angled devices that areintended to be used with bone screws that conform to ISO 5835or ISO
40、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 provides the primary means of stabilizing thebone fragment
41、s. 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 determined using Annex A1.7.2.2 The relevant bending
42、 properties (bending stiffness,bending structural stiffness and bending strength) of thesideplate shall be determined using the Annex A1 of Specifi-cation and Test Methods F 382.7.2.3 Determine the relevant angled device bending fatigueproperties according to the methods described in Annex A2.7.2.4
43、Determine the relevant side plate bending fatigueproperties according to the methods described in Annex A2 ofSpecification and Test Methods F 382.F3840638. Keywords8.1 angled devices; bend testing; blade plate; compressionhip screw; fatigue test; orthopedic medical devices; surgicaldevices; surgical
44、 implantsANNEXES(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 for determining intrinsic, structural properties ofmetallic
45、 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 different angled device designs. It isnot the intention of this te
46、st 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 of clinical failuremodes for the angled fixation devices (f
47、or 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 address all of thesafety concerns, if any, associated with i
48、ts 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:E 4 Practices for Load Verification of Testing MachinesE 122 Prac
49、tice 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).A1.3.1.3 compression bending strength, nof an angleddevice, th
