ASTM F1264-2016 Standard Specification and Test Methods for Intramedullary Fixation Devices《髓内固定装置的标准规格和试验方法》.pdf

1、Designation: F1264 14F1264 16Standard Specification and Test Methods forIntramedullary Fixation Devices1This standard is issued under the fixed designation F1264; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last rev

2、ision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixationd

3、evices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanicalproperties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to developa standard which defines performance criteria and me

4、thods for measurement of performance-related mechanical characteristics ofIMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinicalperformance of these devices, as insufficient knowledge to predict the consequences of th

5、e use of any of these devices in individualpatients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specificdesigns for IMFDs.1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides ba

6、sic IMFD geometricaldefinitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methodsand characteristics determined to be important to in-vivo performance of the device.1.3 Multiple test methods are included in this standard. Howeve

7、r, 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 appropriate for a particular devicedesign. This may be only a subset of the herein described test methods.1.4 This specification include

8、s four standard test methods:1.4.1 Static Four-Point Bend Test MethodAnnex A1 and1.4.2 Static Torsion Test MethodAnnex A2.1.4.3 Bending Fatigue Test MethodAnnex A3.1.4.4 Test Method for Bending Fatigue of IMFD Locking ScrewsAnnex A4.1.5 A rationale is given in Appendix X1.1.6 The values stated in SI

9、 units are to be regarded as standard. No other units of measurement are included in this standard.2. Referenced Documents2.1 ASTM Standards:2A214/A214M Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser TubesA450/A450M Specification for General Requirements for C

10、arbon and Low Alloy Steel TubesD790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating MaterialsE4 Practices for Force Verification of Testing MachinesE691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

11、F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F339 Specification for Cloverleaf Intramedullary Pins (Withdrawn 1998)3F383 Practice for Static

12、 Bend and Torsion Testing of Intramedullary Rods (Withdrawn 1996)3F565 Practice for Care and Handling of Orthopedic Implants and Instruments1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommit

13、teeF04.21 on Osteosynthesis.Current edition approved Nov. 1, 2014May 1, 2016. Published March 2015June 2016. Originally approved in 1989. Last previous edition approved in 20122014 asF1264 03 (2012).F1264 14. DOI: 10.1520/F1264-14.10.1520/F1264-16.2 For referencedASTM standards, visit theASTM websit

14、e, 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.3 The last approved version of this historical standard is referenced on www.astm.org.This document is not an AST

15、M 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 appropriate. In al

16、l 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 States1F1611 Specification for Intramedullary ReamersF2503 Practice for Marking Me

17、dical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentF2809 Terminology Relating to Medical and Surgical Materials and Devices2.2 AMS Standard:AMS 5050 Steel Tubing, Seamless, 0.15 Carbon, Maximum Annealed42.3 SAE Standard:SAE J524 Seamless Low-Carbon Steel Tubing Annealed fo

18、r Bending and Flaring43. Terminology3.1 Definitions for Geometric:3.1.1 closed section, nany cross section perpendicular to the longitudinal axis of a solid or hollow IMFD in which there isno discontinuity of the outer wall.3.1.1.1 DiscussionTo orient the IMFD for testing and for insertion, the desi

19、red relationship of any irregularities, asymmetries,and so forth, to the sagittal and coronal planes for the intended applications should be described.3.1.2 IMFD curvature, ndimensions of size and locations of arcs of the curvature, or mathematical description of thecurvature, or other quantitative

20、descriptions to which the curvature is manufactured along with tolerances.3.1.2.1 DiscussionTo orient the IMFD for testing and for insertion, the desired relationship of the curvature to the sagittal andcoronal planes for the intended applications should be described.3.1.3 IMFD diameter, ndiameter o

21、f the circumscribed circle that envelops the IMFDs cross section when measured along itsworking length. If the diameter is not constant along the working length, then the site of measurement should be indicated.3.1.4 IMFD length, nlength of a straight line between the most proximal and distal ends o

22、f the IMFD.3.1.5 open section, nany cross section perpendicular to the longitudinal axis of a hollow IMFD in which there is adiscontinuity of the outer wall.3.1.5.1 DiscussionTo orient the IMFD for testing and insertion, the desired relationship of the discontinuity to the sagittal andcoronal planes

23、 for the intended applications should be described.3.1.6 potential critical stress concentrator (CSC), nany change in section modulus, material property, discontinuity, or otherfeature of a design expected to cause a concentration of stress in a region of the IMFD expected to be highly stressed unde

24、r thenormal anticipated loading conditions.3.1.7 tolerance, nacceptable deviations from the nominal size of any dimension describing the IMFD.3.1.8 working length, nlength of uniform cross section of the IMFD intended to obtain some type of fit to the medullary canalin the area of the diaphysis.3.2

25、DefinitionsMechanical/Structural:3.2.1 bending compliance, nreciprocal of the stiffness of the IMFD under a bending load in a specified plane as defined anddetermined in the static four-point bend test described in Annex A1.3.2.2 failure strength, nthe force parameter (for example, load, moment, tor

26、que, stress, and so forth) required to meet thefailure criteria, as defined and measured according to the test conducted. (See Note 1.)NOTE 1No present testing standard exists related to this term for IMFDs.3.2.3 fatigue strength at N cycles, nthe maximum cyclic force parameter (for example, load, m

27、oment, torque, stress, and soforth) for a given load ratio, which produces device structural damage or meets some other failure criterion in no less than N cyclesas defined and measured according to the test conducted.3.2.4 Na variable representing a specified number of cycles.3.2.5 no load motionre

28、lative motion between the IMFD and the bone that occurs with no elastic strain in the device and no(or minimal) change in load. (See Note 1.)3.2.6 structural stiffness, nthe maximum slope of the elastic portion of the load-displacement curve as defined and measuredaccording to the test conducted.3.2

29、.6.1 DiscussionFor bending in a specified plane, this term is defined and determined in the static four-point bend testdescribed in Annex A1.3.2.7 ultimate strength, nmaximum force parameter (for example, load, moment, torque, stress, and so forth) which thestructure can support, defined and measure

30、d according to the test conducted.3.2.8 yield strength, nthe force parameter (for example, load, moment, torque, stress, and so forth) which initiates permanentdeformation as defined and measured according to the test conducted.4. Classification4.1 The following IMFDs may be used singly, multiply, a

31、nd with or without attached supplemental fixation: solid cross section,hollow cross section (open, closed, or a combination).4 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.F1264 1624.2 Intended application or use for particu

32、lar IMFD designs:4.2.1 Preferred Orientation:4.2.1.1 Right versus left,4.2.1.2 Sagittal versus coronal plane,4.2.1.3 Proximal versus distal, and4.2.1.4 Universal or multiple options.4.2.2 Preferred Anatomic Location:4.2.2.1 Specific bone,4.2.2.2 Proximal versus distal versus midshaft, and4.2.2.3 Uni

33、versal or multiple options.4.2.3 Preferred Use Limited to Specific Procedures:4.2.3.1 Acute care of fractures,(a) Specific types,(1) Specific types,(2) Specific locations,(b) Specific locations,4.2.3.2 Reconstructive procedures, and4.2.3.3 Universal or multiple options.5. Material5.1 All IMFDs made

34、of materials that have anASTM standard shall meet those requirements given in theASTM standards (2.1).6. Performance Considerations and Test Methods6.1 Cross Section Dimensional Tolerances affect matching the bone preparation instruments (that is, reamers) to the IMFDdiameter, and the IMFD in the bo

35、ne.6.1.1 Terminology related to sizing of IMFD devices and instruments is provided in Specification F1611.6.2 Longitudinal Contour Tolerances (along with bending compliance) affect the fit and fixation of IMFDs in the bone.46.3 Fatigue Strength affects the choice of implant in cases in which delayed

36、 healing is anticipated (that is, infected nonunions,allografts, segmental loss, multiple trauma, and so forth).6.3.1 The fatigue strength or fatigue lives or both for IMFDs subjected to cycle bending forces shall be determined using thecyclic bending fatigue test method in Annex A3.6.3.2 The fatigu

37、e strength or fatigue lives or both for IMFD locking screws subjected to cyclic bending forces shall bedetermined using the cyclic bending fatigue test method for locking screws in Annex A4.6.4 Bending Strength affects the choice of implant in which load sharing is minimized or loading is severe or

38、both (that is, withdistal or proximal locking, subtrochanteric fractures, comminuted fracture, segmental loss, noncompliant patient, and so forth).6.4.1 Yield, failure, and ultimate strength for IMFDs subjected to bending in a single plane shall be determined using the staticfour-point bend test met

39、hod described in Annex A1.6.5 Bending and Torsional Stiffness may affect the type and rate of primary or secondary healing, depending upon the fracturetype (transverse, oblique, and so forth).6.5.1 Bending structural stiffness for IMFDs subjected to bending in a single plane shall be determined usin

40、g the staticfour-point bend test method described in Annex A1.6.5.2 Torsional stiffness for IMFDs subjected to pure torsion shall be determined using the static torsion test method describedin Annex A2.6.6 No-Load Axial and Torsional Motion Allowed in Devices Using Secondary Attached Fixation affect

41、s degree of motion atthe fracture site. (See Note 1.)6.7 Extraction SystemMechanical failures should occur in the extraction device before they occur in the IMFD. This preventsthe need to remove the IMFD without proper tools. (See Note 1.)7. Marking, Packaging, Labeling, and Handling7.1 Dimensions o

42、f IMFDs should be designated by the standard definitions given in 3.1.7.2 IMFDs should be marked using a method in accordance with Practice F86.7.3 Use the markings on the IMFD to identify the manufacturer or distributor. Mark away from the most highly stressed areaswhere possible.7.4 Packaging shal

43、l be adequate to protect the IMFD during shipment.7.5 The following shall be included on package labeling for IMFDs:F1264 1637.5.1 Manufacturer and product name,7.5.2 Catalog number,7.5.3 Lot or serial number,7.5.4 IMFD diameter (3.1.3), and7.5.5 IMFD length (3.1.4).7.6 IMFDs should be cared for and

44、 handled in accordance with Practice F565.7.7 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.8. Means for Insertion and Extraction8.1 For IMFDs

45、 that are to be extracted using a hook device, the following requirements apply:8.1.1 The slot at the end of the IMFD shall have the dimensions shown in Fig. 1.8.1.2 The hook used for extraction shall have the dimensions shown in Fig. 2.9. Keywords9.1 bend testing; definitions; extraction; fatigue t

46、est; fracture fixation; implants; intramedullary fixation devices; orthopaedicmedical device; performance; surgical devices; terminology; test methods; torsion test; traumaIMFD Diameter,mm Hook SizeSlot Length, L,mmSlot Width, W,mm6, 7 2 9.53 1.918 and larger 1 9.53 3.23FIG. 1 Dimensions of Extracto

47、r Hook SlotHook Size Hook Width, A, mm1 3.052 1.78FIG. 2 Dimensions of Extractor HookF1264 164ANNEXES(Mandatory Information)A1. TEST METHOD FOR STATIC FOUR-POINT BEND TESTA1.1. ScopeA1.1.1 This test method describes methods for static four-point bend testing of intrinsic, structural properties of in

48、tramedullaryfixation devices (IMFDs) for surgical fixation of the skeletal system. This test method includes bend testing in a variety of planesrelative to the major anatomic planes. The purpose is to measure bending strength and bending stiffness intrinsic to the design andmaterials of IMFDs.A1.1.2

49、 This test method is designed specifically to test IMFD designs that have a well-defined working length (WL) of uniformopen or closed cross section throughout the majority of its length (WL 10 diameter) and shall be applied to the full length ofthe diaphysis of a femur, tibia, humerus, radius, or ulna. This is not applicable to IMFDs that are used to fix only a short portionof the diaphysis of any of the long bones or the diaphysis of small bones such as the metacarpals, metatarsals, phalanges, and soforth.A1.1.3 This test method is not intend