1、Designation: F543 131F543 17Standard Specification and Test Methods forMetallic Medical Bone Screws1This standard is issued under the fixed designation F543; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision
2、.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1 NOTEAnnex A6 was corrected editorially and portions of the standard were reformatted in December 2013.1. Scope1.1 This specification provides req
3、uirements for materials, finish and marking, care and handling, and the acceptable dimensionsand tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification areapplicable only to metallic bone screws described in this specification.1.2 This s
4、pecification provides performance considerations and standard test methods for measuring mechanical properties intorsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besidesthose whose dimensions and tolerances are specified here. Th
5、e following annexes are included:1.2.1 Annex A1Test Method for Determining the Torsional Properties of Metallic Bone Screws.1.2.2 Annex A2Test Method for Driving Torque of Medical Bone Screws.1.2.3 Annex A3Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.1.2.4 Annex A4Te
6、st Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.1.2.5 Annex A5Specifications for Type HA and Type HB Metallic Bone Screws.1.2.6 Annex A6Specifications for Type HC and Type HD Metallic Bone Screws.1.2.7 Annex A7Specifications for Metallic Bone Screw Drive Co
7、nnections.1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 Multiple test methods are included in this standard. However, it must be noted t
8、hat the user is not necessarily obligated totest using all of the described methods. Instead, the user should only select select, with justification, test methods that areappropriate for a particular device design. In most instances, only This may only be a subset of the herein described test method
9、swill be required.methods.1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport toaddress all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establishappropriate safet
10、y and health practices and determine the applicability of regulatory limitations prior to use.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 Standa
11、rds, 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 MachinesE6 Terminology Relating to Methods of Mechanical TestingE8 Test Methods for Tension Test
12、ing of Metallic MaterialsE122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot orProcess1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibi
13、lity of SubcommitteeF04.21 on Osteosynthesis.Current edition approved May 1, 2013March 1, 2017. Published June 2013April 2017. Originally approved in 1977. Last previous edition approved in 20092013 asF543 07F543 131. DOI: 10.1520/F0543-13E01.10.1520/F0543-17.2 For referencedASTM standards, visit th
14、eASTM 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 document is not an ASTM standard and is intended only to provide the user of an ASTM standard an
15、 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 appropriate. In all cases only the current versionof the standard as published by ASTM is to
16、 be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F86 Practice for Surface P
17、reparation and Marking of Metallic Surgical ImplantsF116 Specification for Medical Screwdriver BitsF136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybde
18、num Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F565 Practice for Care and Handling of Orthopedic Implants and InstrumentsF620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta ConditionF799 Specification for Cobalt-28Chromium-6Molybdenum Alloy
19、Forgings for Surgical Implants (UNS R31537, R31538,R31539)F983 Practice for 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 Chro
20、mium13 Nickel5 Manganese2.5 Molybdenum StainlessSteel Alloy Bar and Wire for Surgical Implants (UNS S20910)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgica
21、l Implants (UNS R31537, UNSR31538, and UNS R31539)F1586 Specification for Wrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum StainlessSteel Alloy Bar for Surgical Implants (UNS S31675)F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Appli
22、cations (UNS R58130)F1813 Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices andInstrumentsF2066 Specification for Wrought Titanium-15 M
23、olybdenum Alloy for Surgical Implant Applications (UNS R58150)F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment2.2 ISO Standards:35835 Implants for SurgeryMetal Bone Screws with Hexagonal Driver Connection, Spherical Under Surface of Head,Asy
24、mmetrical ThreadDimensions6475 Implants for SurgeryMetal Bone Screws with Asymmetrical Thread and Spherical Under-SurfaceMechanicalRequirements and Test Methods8319-1 Orthopaedic InstrumentsDrive connectionsPart 1: Keys for use with hexagon socket heads8319-2 Orthopaedic InstrumentsDrive connections
25、Part 2: Screwdrivers for single slot head screws, screws with cruciateand cross-ecessed head screws9268 Implants for SurgeryMetal Bone Screws with Conical Under-Surface of HeadDimensions10664 Hexalobular Internal Driving Feature for Bolts and Screws3. Terminology3.1 DefinitionsSome of the terms defi
26、ned in this section are shown in Fig. 1.3 Available from American National Standards Institute, 25 W. 43rd St., 4th Floor, New York, NY 10036.FIG. 1 Schematic of Screw TermsF543 1723.1.1 axial pullout strengththe tensile force required to fail or remove a bone screw from a material into which the sc
27、rew hasbeen inserted.3.1.2 breaking angleangle of rotation when the screw fails in torsion as demonstrated by a rapid decrease in the indicatedtorque.3.1.3 buttress threadan asymmetrical thread profile characterized by a pressure flank which is nearly perpendicular to thescrew axis.3.1.4 cancellous
28、screwa screw designed primarily to gain purchase into cancellous bone. Cancellous screws typically have anHB (see 4.1.2) thread and may or may not be fully threaded.3.1.5 cortical screwa screw designed primarily to gain biocortical purchase into cortical bone. Cortical screws typically havea HA (see
29、 4.1.1) thread and are fully threaded.3.1.6 core diameterthe smallest diameter of the threaded portion of the screw measured at the thread root. This is also knownas the minor diameter or root diameter.3.1.7 gage lengththe distance between the holding device (for example, a split collet) and the und
30、erside of the screw head.3.1.8 grip lengththe length of threads held fast in the split collet or other holding mechanism.3.1.9 insertion depththe threaded length as inserted into the test block.3.1.10 insertion torquethe amount of torque required to overcome the frictional force between the screw an
31、d the material usedfor testing while driving the screw into the material.3.1.11 maximum torque (N-m)the largest value of torque recorded during the period of rotation before screw failure intorsional shear when tested in accordance with Annex A1.3.1.12 nontapping screwa screw that has a tip that doe
32、s not contain a flute. Nontapping screws usually require a tap to beinserted into the pilot hole before the insertion of the screw, when used in moderate or hard bone.3.1.13 partially threaded screwa screw whose threaded portion does not extend fully from the screw point to the screw headbut instead
33、 has a smooth shaft running between the head and threads.3.1.14 pilot holethe hole drilled into the bone into which the screw tip is inserted. The pilot hole is normally slightly largerthan the screws core diameter. However, if the screw is to be used to provide compression across a fracture, a port
34、ion of the pilothole may be larger to allow for a clearance fit.3.1.15 pitchthe length between the thread crests.3.1.16 removal torquethe amount of torque required to overcome the frictional force between the screw and the material usedfor testing while removing the screw from the material (for exam
35、ple, counterclockwise rotation for right-hand thread).3.1.17 screw headthe end of the screw which is opposite of the tip and fromto which the means of inserting the screw iscoupled.3.1.18 screw lengththe overall length of the screw measured from the screw head to the screw tip.3.1.19 screw threada h
36、elical groove on a cylindrical or conical surface. The projecting helical ridge thus formed is called ascrew thread, consisting of peaks (crests) and valleys (roots).3.1.20 self-tapping force (N)the amount of axial force required to engage the self-tapping features of self-tapping style screwswhen t
37、ested in accordance with Annex A4.3.1.21 self-tapping screwa screw that has any number of flutes at its tip which are intended to cut the screws thread forminto the bone upon insertion.3.1.22 sizean identification of a screw based on its nominal thread diameter, as defined in Section 6.3.1.23 solid
38、corea screw that does not contain a cannulation along its longitudinal axis.3.1.24 thread diameterthe largest diameter of the threaded portion of the screw measured over the thread crests. This is alsoknown as the major diameter.3.1.25 thread lengththe length of the threaded portion of the screw, me
39、asured from the thread runout to the screw tip.3.1.26 thread runoutthe intersection of the screw thread with either the screw shaft or screw head.3.1.27 torsional yield strength (N-m)the point at which the screw reaches its proportional limit when tested in accordance withAnnex A1. This will be dete
40、rmined by the offset method. A 2 offset value shall be used.4. Classification4.1 There are a large variety of medical bone screws currently in use. They may be classified by the definitions provided inSection 3. This specification currently includes information that defines the following types of sc
41、rews:4.1.1 Type HASpherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head.4.1.2 Type HBSpherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head.F543 1734.1.3 Type HCConical undersurface of head, symmetrical thread.4.1.4 Type HDConi
42、cal undersurface of head, asymmetrical thread.5. Material5.1 Screws shall be fabricated from a metallic material intended for surgical implant applications, and having meeting therequirements for an ASTM medical material. In addition, the materials shall be biocompatible for the intended application
43、.6. Dimensions and Tolerances6.1 There are many types of metallic bone screw designs available, so a complete list of dimensions and tolerances for all screwscovered by this specification is unfeasible. However, this specification does provide required dimensions and tolerances for fourtypes of scre
44、ws as classified in 4.1. Screws conforming to this specification, and designated HA, HB, HC, or HD screws, shall befabricated in accordance with the dimensions and tolerances described in Annex A5 and Annex A6, respectively7. Finish and Marking7.1 The screw shall be free from nicks, dents, burrs, an
45、d scratches when examined in accordance with Practice F86.7.2 When size permits, the following information should be legibly marked on the head of the screw (in order of preference):7.2.1 Manufacturers name or logo,7.2.2 Screw SizeIf a screw is manufactured in accordance with ASTM or ISO specificati
46、ons, the ASTM or ISO designationshould be provided,7.2.3 Material,7.2.4 Catalog number, and7.2.5 Manufacturing lot number.7.3 Screws shall be marked in accordance with Practice F983, unless otherwise specified in 7.2, in a manner such that themechanical integrity of the screw is not compromised.8. C
47、are and Handling8.1 Screws should be cared for and handled in accordance with Practice F565, as appropriate.8.2 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
48、 MR environment.9. Driving Instruments9.1 Avariety of screwdrivers exist for the insertion and removal of bone screws. screws exist. The classification and dimensionsfor various screw-drive recesses currently used in the medical industry are documented in Annex A7. Specification F116 providesrelated
49、 dimensional information for several types of medical screwdrivers.9.2 Screws conforming to this specification, and designated HA, HB, HC, or HD screws, shall be manufactured with driverecesses that conform to the requirements specified in Annex A5 and Annex A6, respectively10. Performance Considerations and Test Methods10.1 The following properties may be important when determining the suitability of a screw for a particular application.However, the test methods referenced as follows may not be appropriate for al
