1、Designation: F384 17Standard 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. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () 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 surgicalin
3、ternal 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, an
4、dstandard 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 insufficie
5、nt 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 ma
6、y 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 without
7、 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 St
8、andard 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 standar
9、d that is either similar toequivalent to this standard.1.6 Multiple test methods are included in this standard.However, the user is not necessarily obligated to test using allof the described methods. Instead, the user should only select,with justification, test methods that are appropriate for apar
10、ticular device design. This may be only a subset of theherein described test methods.1.7 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Gu
11、ides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.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
12、Size to Estimate, WithSpecified Precision, the Average for a Characteristic of aLot or ProcessF67 Specification for Unalloyed Titanium, for Surgical Im-plant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Al
13、loy for Surgical Implants(UNS R30075)F90 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)F13
14、8 Specification for Wrought 18Chromium-14Nickel-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 Sur-gical Implants (UNS S31673)1These specifications and test methods are u
15、nder 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 Feb. 1, 2017. Published March 2017. Originallyapproved in 1973. Last previous edition approved in 2012 as F384 1
16、2. DOI:10.1520/F0384-17.2For 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 standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Bar
17、r Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recomm
18、endations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1F382 Specification and Test Method for Metallic Bone PlatesF565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF620 Specification for Titanium Alloy Forgings for SurgicalImplants in the
19、 Alpha Plus Beta ConditionF621 Specification for Stainless Steel Forgings for SurgicalImplantsF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F1314 Specification for W
20、rought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 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-13Niob
21、ium-13Zirconium Alloy for Surgical Implant Applications(UNS R58130)F2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment2.2 ISO Standards:3ISO 5835 Implants for SurgeryMetal Bone Screws withHexagonal Drive ConnectionSpherical Under Surfaceof Head,
22、 Asymmetrical ThreadISO 5836 Implants for SurgeryMetal Bone PlatesHolescorresponding to Screws with Asymmetrical Thread andSpherical Under SurfaceISO 9268 Implants for SurgeryMetal Bone Screws withConical Under-Surface of HeadDimensionsISO 9269 Implants for SurgeryMetal Bone PlatesHolesand Slots cor
23、responding to Screws with Conical Under-SurfaceISO 14602 Non-active Surgical ImplantsImplants forOsteosynthesisParticular Requirements3. Terminology3.1 Definitions: Geometric3.1.1 angle (degree)defined at either the barrel/sideplateor blade/sideplate junction (see Fig. 1 and Fig. 2).3.1.2 angled dev
24、icean 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 barrelthe 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 f
25、reeend 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 of the anatomical loading condition tothe sideplate portion of the angled device (see Fig. 2).3.1.6 blade length, LBD(mm)the dista
26、nce 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 which is threaded into the metaphysis andtransmits the off axis load to the sideplate through the barrel(see Fig. 1).3.1.8 lag sc
27、rew 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 generallyaligned with the long axis of the bone which attaches to thebone via bone screws (see Fig. 1 and Fig. 2).3.1.10 sideplate lengt
28、h, 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(see Fig. 1 and Fig. 2).3.1.11 sideplate thickness, b (mm)the linear dimension ofthe sideplate measured parallel to the screw hole a
29、xis (see Fig.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 DevicesF384 1721 and Fig. 2). For a sideplate with a crescent section, thethickness is measured at the
30、thickest point along the section.3.1.12 sideplate width, w (mm)the linear dimension of thesideplate measured perpendicular to both the length andthickness axes (see Fig. 1 and Fig. 2).3.1.13 thread diameter (mm)the maximum outer diameterof the lag screw threads (see Fig. 1).3.1.14 thread length (mm)
31、the straight line distance mea-sured between the tip and thread runout positions of the screw(see Fig. 1).3.2 Definitions: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
32、Annex A1 ofSpecification and Test Method F382.3.2.2 bending structural stiffness, Ele(N-m2)of thesideplate, the normalized effective bending stiffness of thesideplate that takes into consideration the test setup configu-ration when tested according to the method described in AnnexA1.3.2.3 compressio
33、n bending stiffness, (K) (N/m)of a device,the maximum slope of the linear elastic portion of the loadversus displacement 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 w
34、hen tested as described in Annex A1.3.2.5 fatigue strength at N cyclesan estimate of the cyclicforcing parameter (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
35、fatigue life, 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 surgeryrepresents a subset of bone plates. Angled devices are mainlyused in the treatment of fr
36、actures 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 relative to the sidepla
37、te; this component oftenis shaped like a blade to achieve fixation into the metaphysis(see Fig. 2), and4.1.2 Compression 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 barr
38、el; this component often achieves fixation intothe metaphysis 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
39、-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 situated away from the mosthighly stressed areas, where possible.5.4 Packaging shall be adequate to protect the angled deviceduring shipment.5.5 Packa
40、ge 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 the sideplate
41、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 with Practice F
42、565, as appropriate.5.7 Consider Practice F2503 to identify potential hazardsproduced by interactions between the device and the MRenvironment and for terms that may be used to label the devicefor safety in the MR environment.6. Materials6.1 All angled devices made of materials which can bepurchased
43、 to an ASTM specification 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 Specif
44、ication F138 shall meetthe requirements of Specification F621.FIG. 2 Diagram Illustrating Blade Plate Angled DevicesF384 1737. General Requirements and PerformanceConsiderations7.1 Geometric ConsiderationsFor angled devices that areintended to be used with bone screws that conform to ISO 5835or ISO
45、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
46、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
47、 properties (bending stiffness,bending structural stiffness and bending strength) 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 De
48、termine the relevant side plate bending fatigueproperties according to the methods 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 implantsAN
49、NEXES(Mandatory Information)A1. STANDARD TEST METHOD FOR SINGLE CYCLE COMPRESSION BEND TESTING OF METALLIC ANGLED ORTHO-PEDIC 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 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 dif
