ASTM F564-2017 Standard Specification and Test Methods for Metallic Bone Staples《骨科用金属U形钉的标准规格和试验方法》.pdf

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1、Designation: F564 10 (Reapproved 2015)F564 17Standard Specification and Test Methods forMetallic Bone Staples1This standard is issued under the fixed designation F564; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of las

2、t revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internalfixa

3、tion of the muscular skeletal musculoskeletal system. It is not the intention of this specification to describe or specify specificdesigns for metallic bone staples.1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:1.2.1 Test

4、 Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone StaplesAnnex A1.1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone StaplesAnnex A2.1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone StaplesAnnex A3.1.2.4 Test Method for Elastic Static Bending of

5、 Metallic Bone StaplesAnnex A4.1.3 The values stated in SI units are to be regarded as standard. NoAny other units of measurement are included in thisstandard.standard are shown for reference only.1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated

6、 to test using all of thedescribed methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular devicedesign. This may be only a subset of the herein described test methods.1.5 This standard does not purport to address all of the safety concer

7、ns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance

8、 with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standar

9、ds:2E4 Practices for Force Verification of Testing MachinesE122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot orProcessE467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing SystemF75 Spe

10、cification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF382 Specification and Test Method for Metallic Bone PlatesF565 Practice for Care and Handling of Orthopedic

11、Implants and InstrumentsF601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic Surgical ImplantsF2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment3. Finish3.1 Staples conf

12、orming to this specification shall be finished and identified in accordance with Practice F86, as appropriate.1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Cu

13、rrent edition approved March 1, 2015Sept. 1, 2017. Published April 2015October 2017. Originally approved in 1985. Last previous edition approved in 20102015 asF564 10.F564 10 (2015). DOI: 10.1520/F0564-10R15.10.1520/F0564-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or con

14、tactASTM 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 indication of what changes have be

15、en 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 be considered the official documen

16、t.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14. Inspection Practices4.1 Staples made in accordance with Specification F75 should be inspected in accordance with Practice F601 or X-rayed inaccordance with Practice F629.5. Care and

17、 Handling5.1 Staples should be cared for and handled in accordance with Practice F565, as appropriate.5.2 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 MR en

18、vironment6. Materials6.1 Bone staples shall be fabricated from a metallic material intended for surgical implant applications. In addition, the materialsshall be biocompatible for the intended application. Materials should be chosen based on the design requirements of the particulardevice. ASTM subc

19、ommittee F04.12 maintains a number of specifications for materials that are suitable for surgical implantapplications.7. Keywords7.1 bending test; bone fixation; fatigue test; fixation devices; metallic bone staples; orthopaedic medical devices; pullout test;soft tissue fixation; surgical implantsAN

20、NEXES(Mandatory Information)A1. TEST METHOD FOR CONSTANT AMPLITUDE BENDING FATIGUE TESTS OF METALLIC BONE STAPLESA1.1. ScopeA1.1.1 This test method covers procedures for the performance of constant amplitude fatigue testing of metallic staples used ininternal fixation of the musculoskeletal system.

21、This test method may be used when testing in air at ambient temperature or in anaqueous or physiological solution.A1.1.2 The values stated in SI units are to be regarded as standard. NoAny other units of measurement are included in thisstandard.standard are shown for reference only.A1.1.3 This stand

22、ard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.A1.

23、1.4 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Tr

24、ade (TBT) Committee.A1.2. Summary of Test MethodA1.2.1 Metallic bone staples are tested under bending loads until the specimen fails or a predetermined number of cycles has beenapplied to it. Bending tests may be performed in one of two modes: either pure, in-plane bending; or tension (or compressio

25、n)combined with in-plane bending. Tests using either of these methods may be conducted at ambient conditions or in aqueous orphysiological solutions (at either room temperature or 37C).A1.3. Significance and UseA1.3.1 This test method is used to determine the fatigue resistance of metallic bone stap

26、les when subjected to repetitive loadingfor large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry,surface condition, or placement under certain circumstances.A1.3.2 It is essential that uniform fatigue practices be establishe

27、d in order that such basic fatigue data be comparable andreproducible and can be correlated among laboratories.F564 172A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the testconditions exactly. This test method may not be a

28、ppropriate for all types of bone staple applications. The user is cautioned toconsider the appropriateness of the test method in view of the materials being tested and their potential application.A1.4. ApparatusA1.4.1 Testing Machines, conforming to the requirements of Practices E4 and E467.The load

29、s used for determining strengths shallbe within the loading range of the testing machine as defined in Practices E4 and E467.A1.4.2 Gripping Devices:A1.4.2.1 Staple ExtensionsPairs of specially designed metal blocks that permit the holding of individual staples for theapplication of bending fatigue

30、loads. The legs of each staple are fitted into fixation holes in each block with minimal clearance torestrict bending of the staple within the hole. The staple is fixed securely in the block using a moldable filling or grouting agent.The extension design should minimize the weight to reduce the infl

31、uence on the staple while maintaining sufficient stiffness totransfer the load to the staple without undesirable deflection. Holes for pin and clevis fixation are optional (see Figs. A1.1-A1.3).NOTE A1.1Variations in fixation hole configuration may be required for staple legs with noncircular cross

32、sections. Also, it is necessary to provide agap between the underside of the staple bridge and edge of the staple extender in most cases. This is necessary to eliminate contact between the staplebridge (or other bridge features such as tissue spikes) and the staple extender. However, this gap should

33、 be standardized within any test group as required.A1.4.2.2 4-Point Bend FixtureA standard or modified bending fixture that produces pure bending in the staple withoutappreciable shear or torsion when used to apply load to the staple through the staple extensions.A1.4.2.3 Pin and Clevice FixtureA st

34、andard or modified fixture used to apply a distractive or compressive load to the staplethrough the staple extensions to produce bending in the staple similar to that seen in vivo.A1.4.3 Filling or Grouting AgentA stiff, moldable filler, such as epoxy, acrylic cement, or a low-melting point alloy (f

35、orexample, Woods metal) used to secure the staple leg within the staple extension.A1.4.4 Aqueous SolutionTap water, distilled water, physiological saline, or similar aqueous solutions, used to immerse the testspecimens fully during the test.FIG. A1.1 4-Point Bending of Staples in ExtensionF564 173A1

36、.4.5 Constant Temperature BathAn aqueous bath capable of maintaining the samples and containers at physiologictemperatures, 37 6 2C, for the specified testing periods.A1.5. Test SpecimenA1.5.1 StapleA generally U-shaped metal loop, with at least two legs, that is driven into the surface of bone to e

37、ither fix orimmobilize adjacent pieces of bone or to fasten soft tissue or other material to bone. All test samples shall be representative of thematerial under evaluation. Samples for comparative tests shall be produced from the same material lot or batch and under the samefabricating conditions, u

38、nless noted specifically.FIG. A1.2 Combined Tension (or Compression) and Bending of StaplesFIG. A1.3 Diagram of Extender-Staple Forces Under Combined Bending and TensionF564 174A1.5.2 Staple LegThe parallel or nearly parallel extensions that are intended to penetrate the bone tissue; these may be ro

39、und,square, or polygonal in cross section, and they may possess serrations or barbs to increase the fixation or purchase strength in thebone.A1.5.3 Staple BridgeThe cross member of the staple connecting the legs; the bridge may be smooth or possess spikes orprojections on the underside for the reten

40、tion of soft tissue or other material.A1.6. ProcedureA1.6.1 Mounting the SpecimenFix the staple leg in an extension block using the filling agent.Afixture should be used to ensureproper in-plane alignment of the two extensions and the staple during this process. Also, each staple should be fixed suc

41、h that thebridge is the same distance from the top of each extension.NOTE A1.2This distance is at the discretion of the operator, but it determines the portion of the staple subjected to the bending loads.A1.6.2 4-Point Bend Testing:A1.6.2.1 Place the staple and attached staple extensions in the 4-p

42、oint bending fixture such that the loading point and supportrollers contact the staple extensions on either side of the staple; direct contact of the rollers with the staple shall not be permittedduring the test. Alignment of the loading point rollers shall be symmetric on the centerline between the

43、 support rollers (see Fig.A1.1).A1.6.2.2 Apply cyclic loads (sinusoidal, sawtooth, and so forth), generating bending moments in the staple without permanentdeformation. Appropriate starting loads should be 50 to 75 % of the static bending strength, unless indicated otherwise.NOTE A1.3It may be neces

44、sary to provide a low-friction means of maintaining the position of the staple and attached extensions. Also, the fixturesshould be designed so that loads are applied equally at the loading points during each deflection throughout the test.A1.6.2.3 Compute the bending moment, M, by the following for

45、mula, where F = force applied at each loading point and A =distance between the loading point and support roller,roller:Mbending 5FA (A1.1)Mbending = FA.A1.6.2.4 Continue the test until failure of the staple, the fixation, or a predetermined number of load cycles hashave been applied.A1.6.3 Combined

46、 Tension or (Compression) and Bending:A1.6.3.1 Place the staple and attached staple extensions in the axial bending fixture. The pins and clevices should permit freerotation of the staple extensions, with minimal friction, while maintaining alignment of the staple legs (and extensions) in the samepl

47、ane (see Fig. A1.2).A1.6.3.2 Apply cyclic loads (sinusoidal, sawtooth, and so forth), generating bending moments in the staple without permanentdeformation. Appropriate starting loads should be 50 to 75 % of the static yield strength, unless indicated otherwise.NOTE A1.4It may be necessary to mainta

48、in a minimum tensile or compressive load on the specimen throughout the test, since operating at or near zeroload may result in either loss of machine control due to discontinuity in the load feedback loop or undesirable transient loading of the staple.A1.6.3.3 Compute the bending moment in the stap

49、le bridge, M, by the following formula, where F = force applied at each centerof each pin and L = distance between the load application axis, thataxis (that is, the pin center,center) and the neutral axis of thestaple bridge, bridge:Mbending5FL see Fig. A1.3! (A1.2)Mbending = FL (see Fig. A1.3).NOTE A1.5The application of this test method produces bending, tensile (or compressive), and shear stresses in the staple. The direction and magnitudesof these stresses should be analyzed using superposition theory or other suitable methods.F564 175A1.6.3.4 Co