1、Designation: F384 12F384 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, t
2、he 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 comprehensive reference for angled devices used in the surgical
3、 internalfixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performancecharacteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling,and handling requirements, an
4、d standard test methods for measuring performance related mechanical characteristics determinedto be important to the in vivo performance of angled devices.1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angleddevices, as insuffi
5、cient knowledge is available to predict the consequences of their use in individual patients for specific activitiesof daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgicalinternal fixation of the skeletal system.1.3 This standa
6、rd may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriatenessof this standard in view of a particular angled device and its potential application.NOTE 1This standard is not intended to address intramedullary hip screw nails or other angled devices w
7、ithout a sideplate.1.4 This standard includes the following test methods used in determining the following angled device mechanical performancecharacteristics:1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (seeAnnex A1).1.
8、4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices(see Annex A2).1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.NOTE 2There is currently no ISO
9、standard that is either similar to equivalent to this standard.1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of thedescribed methods. Instead, the user should only select, with justification, test methods that are appropriat
10、e for a particular devicedesign. This may be only a subset of the herein described test methods.1.7 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Stan
11、dards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers 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
12、 Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot orProcessF67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)1 These specifications and test methods are under the jurisdiction ofASTM
13、Committee F04 on Medical and Surgical Materials and Devices and are the direct responsibilityof Subcommittee F04.21 on Osteosynthesis.Current edition approved May 15, 2012Feb. 1, 2017. Published June 2012March 2017. Originally approved in 1973. Last previous edition approved in 20112012 asF384 06 (2
14、011).F384 12. DOI: 10.1520/F0384-12.10.1520/F0384-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This doc
15、ument 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 depict all changes accurately, ASTM recommends that users consult prior editions as
16、 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 19428-2959. United States1F75 Specification for Cobalt-28 Chromium-6 Molybdenum Al
17、loy Castings and Casting Alloy for Surgical Implants (UNSR30075)F90 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 ImplantAp
18、plications (UNS R56401)F138 Specification 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)F382 Specification a
19、nd Test Method for Metallic Bone PlatesF565 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
20、 Permanent Marking of Orthopaedic Implant ComponentsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium13 Nickel5 Manganese2.5 Molybdenum StainlessSteel Alloy Bar and Wire fo
21、r 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 Surgical Implant Applications (UNS R58130)F2503 Practice for Marking Medical Devic
22、es and Other Items for Safety in the Magnetic Resonance Environment2.2 ISO Standards:3ISO 5835 Implants for SurgeryMetal Bone Screws with Hexagonal Drive ConnectionSpherical Under Surface of Head,Asymmetrical ThreadISO 5836 Implants for SurgeryMetal Bone PlatesHoles corresponding to Screws with Asym
23、metrical Thread and SphericalUnder SurfaceISO 9268 Implants for SurgeryMetal Bone Screws with Conical Under-Surface of HeadDimensionsISO 9269 Implants for SurgeryMetal Bone PlatesHoles and Slots corresponding to Screws with Conical Under-SurfaceISO 14602 Non-active Surgical ImplantsImplants for Oste
24、osynthesisParticular Requirements3. Terminology3.1 Definitions: Geometric3.1.1 angle (degree)defined at either the barrel/sideplate or blade/sideplate junction (see Fig. 1 and Fig. 2).3.1.2 angled devicean orthopaedic device for the fixation of fractures in the metaphyseal areas of long bones that h
25、as acomponent aligned at an angle to the long axis of the bone.3.1.3 barrelthe portion of an angled device which captures the lag screw (see Fig. 1).3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.FIG. 1 Diagram Illustr
26、ating Compression Hip Screw Angled DevicesF384 1723.1.4 barrel length, LBR (mm)the distance from the free end of the barrel to the interior vertex of the barrel/sideplate junction(see Fig. 1).3.1.5 bladethe portion of an angled device which transmits the off axis loading of the anatomical loading co
27、ndition to thesideplate portion of the angled device (see Fig. 2).3.1.6 blade length, LBD (mm)the distance from the free end of the blade to the interior vertex of the blade/sideplate junction(see Fig. 2).3.1.7 lag screwthat component of a compression hip screw angled device which is threaded into t
28、he metaphysis and transmitsthe off axis load to the sideplate through the barrel (see Fig. 1).3.1.8 lag screw length (mm)the straight line distance measured between the proximal and distal ends of the lag screw (see Fig.1).3.1.9 sideplatethat portion of the angle device generally aligned with the lo
29、ng axis of the bone which attaches to the bone viabone screws (see Fig. 1 and Fig. 2).3.1.10 sideplate length, L (mm)the distance from the free end 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
30、).3.1.11 sideplate thickness, b (mm)the linear dimension of the sideplate measured parallel to the screw hole axis (see Fig. 1and Fig. 2). For a sideplate with a crescent section, the thickness is measured at the thickest point along the section.3.1.12 sideplate width, w (mm)the linear dimension of
31、the sideplate measured perpendicular to both the length and thicknessaxes (see Fig. 1 and Fig. 2).3.1.13 thread diameter (mm)the maximum outer diameter of the lag screw threads (see Fig. 1).3.1.14 thread length (mm)the straight line distance measured between the tip and thread runout positions of th
32、e screw (seeFig. 1).3.2 Definitions:Mechanical/Structure:3.2.1 bending strength (N-m)of the sideplate, the bending moment necessary to produce a 0.2 % offset displacement in thesideplate when tested as described in Annex A1 of Specification and Test Method F382.3.2.2 bending structural stiffness, El
33、e (N-m2)of the sideplate, the normalized effective bending stiffness of the sideplate thattakes into consideration the test setup configuration when 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
34、 portion of the load versusdisplacement curve, when tested as described in Annex A1.3.2.4 compression bending strength (N/m)of a device, the bending moment necessary to produce a 0.2 % offset displacementin the device when tested as described in Annex A1.3.2.5 fatigue strength at N cyclesan estimate
35、 of the cyclic forcing parameter (for example, load, moment, torque, stress, etc.)at a given load ratio, for which 50 % of the specimens within a given sample population would be expected to survive N loadingcycles.3.2.6 fatigue life, Nthe number of loading cycles of a specified character that a giv
36、en specimen sustains before failure of aspecified nature occurs.4. Classification4.1 Angled devices used in general orthopedic surgery represents a subset of bone plates. Angled devices are mainly used inthe treatment of fractures in the metaphyseal areas of long bones. Angled devices can be categor
37、ized into general types accordingto the following classifications:FIG. 2 Diagram Illustrating Blade Plate Angled DevicesF384 1734.1.1 Blade Platean angled device where the component of the device that is oriented at an angle from the long axis of thebone is fixed relative to the sideplate; this comp
38、onent often is shaped like a blade to achieve fixation into the metaphysis (see Fig.2), and4.1.2 Compression Hip Screwan angled device where the component of the device which is oriented at an angle from the longaxis of the bone is free to translate relative to the sideplate through a barrel; this c
39、omponent often achieves fixation into themetaphysis through the use of deep threads (see Fig. 1).5. Marking, Packaging, Labeling and Handling5.1 Dimensions of angled devices should be designated by the standard definitions given in 3.1.5.2 Angled devices shall be marked using a method specified in a
40、ccordance with either Practice F983 or ISO 14602.5.3 Markings on angled devices shall identify the manufacture or distributor and shall be situated away from the most highlystressed areas, where possible.5.4 Packaging shall be adequate to protect the angled device during shipment.5.5 Package labelin
41、g for angled devices 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 and, where applicable, its associated ASTM specification designation number;5.5.5 Device angle, between the sideplate and the
42、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 accordance with Practice F565, as
43、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 angled devices made of materials which can be purchased to a
44、nASTM specification shall meet those requirements givenin the ASTM specification. Such specification include: F67, F75, F90, F139, F1295, F1314, F1472, and F1713.6.2 Angled devices of forged Specification F136 shall meet the requirements of Specification F620.6.3 Angled devices of forged Specificati
45、on F138 shall meet the requirements of Specification F621.7. General Requirements and Performance Considerations7.1 Geometric ConsiderationsFor angled devices that are intended to be used with bone screws that conform to ISO 5835 orISO 9268, the screw holes shall correspond to the dimensions and tol
46、erances of ISO 5836 or ISO 9269, respectively.7.2 Bending PropertiesBending properties are a critical characteristic of angled devices for orthopedic applications since theplate provides the primary means of stabilizing the bone fragments. Additionally, the bending stiffness of the angled device may
47、directly affect the rate and ability of healing.7.2.1 The relevant compression bending properties (compression bending stiffness and compression bending strength) of thedevice shall be determined using Annex A1.7.2.2 The relevant bending properties (bending stiffness, bending structural stiffness an
48、d bending strength) of the sideplate shallbe determined using the Annex A1 of Specification and Test Method F382.7.2.3 Determine the relevant angled device bending fatigue properties according to the methods described in Annex A2.7.2.4 Determine the relevant side plate bending fatigue properties acc
49、ording to the methods described in Annex A1 ofSpecification and Test Method F382.8. Keywords8.1 angled devices; bend testing; blade plate; compression hip screw; fatigue test; orthopedic medical devices; surgical devices;surgical implantsF384 174ANNEXES(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 cycle bend testing for determining intrinsic, structural properties of metallic
