ASTM F366-2010 Standard Specification for Fixation Pins and Wires《固定插脚和固定线缆的标准规范》.pdf

1、Designation: F366 10Standard Specification forFixation Pins and Wires1This standard is issued under the fixed designation F366; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision.Anumber in parentheses indica

2、tes the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope1.1 This specification covers functional dimensions forfixation pins and wires.1.2 In re

3、cognition of many broad and varied uses of suchpins and wires, many options are included. A variety, but notnecessarily all, of the options are illustrated in Figs. 1-3.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.2. Refe

4、renced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surfac

5、e Preparation and Marking of Me-tallic Surgical ImplantsF90 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 Applicat

6、ions (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F368 Specification for Fixation Pins-Knowles and HagieTypes3F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Impl

7、antApplications (UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)3F1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and

8、 Wire for Surgical Implants(UNS S20910)F1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for Surgica

9、lImplants (UNS S31675)3. Materials3.1 Fixation pins and wires shall be fabricated from materialconforming to one of the followingASTM Specifications: F67,F75, F90, F136, F138, F562, F563, F1314, F1537, and F1586.4. Performance Requirements4.1 Factors considered to be important, but for which valuesa

10、nd test methods have not been established, are bendingstrength, fatigue strength, breaking strength (Knowles Typeonly), torsion strength, and ductility.5. Dimensions and Characteristics5.1 Fixation pins and wires shall be fabricated in accordancewith the dimensions illustrated in Figs. 1-4.5.2 Fixat

11、ion pins and wires shall have surfaces prepared andmarked in accordance with Practice F86.5.2.1 Optional marking on the fixation pins and wires shallidentify the manufacturer or distributor.6. Packaging and Labeling6.1 Packaging shall be adequate to protect the fixation pinsand wires during shipment

12、.6.2 Labeling for fixation pins and wires shall include:6.2.1 Product name,1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved June 1, 2010.

13、Published July 2010. Originally approvedin 1973. Last previous edition approved in 2009 as F366 04 (2009). DOI:10.1520/F0366-10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume informatio

14、n, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.2.2 Size, on the immediate container,6.2.2.1 Length,6.2.2.2 Diameter (if round) or cross-sectional size (

15、if squareof hexagonal), that is, 6.4 mm square, and6.2.3 ASTM material specification Designation number.7. Keywords7.1 fixation materials; flexible surgical wire; orthopaedicmedical devices; wire-surgical implantsNOTE 1Pins and wires may be smooth shank or threaded.NOTE 2Point angle and helix angle,

16、 where applicable, is as specified by manufacturer.NOTE 3On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins largerthan 3.2 mm may be reduced.NOTE 4Optional designs, both ends pointed or point with suture hole.FIG. 1

17、Fixation Pins and WiresF366 102NOTE 1Shall be made of one piece of material; that is, not an assembly of two or more pieces.NOTE 2Thread major diameter may be the same or larger than the shaft diameter.NOTE 3Thread length shall be optional to suit intended medical application.NOTE 4Optional marking

18、in this location.FIG. 2 Fixation Pin-Knowles TypeNOTE 1Thread major diameter may be the same or larger than the shaft diameter.NOTE 2Thread length shall be optional to suit intended medical application.FIG. 3 Fixation Pin-Hagie TypeF366 103APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The prim

19、ary reasons for the revision of this specifi-cation are:X1.1.1 To characterize fixation pins and wires used in thetreatment of fractures or disease of the skeletal system.X1.1.2 To incorporate fixation pinsKnowles and Hagietypes (Specification F368).X1.1.3 To specify marking nomenclature.X1.1.4 To a

20、dd performance requirements in accordancewith Performance Sections request.X1.1.5 To add packaging and labeling.X1.1.6 To remove the dimensions on the Crowe since thedimensions are not essential.X1.1.7 Specific surface finish was considered, however, notincluded, since test data to confirm what the

21、requirementshould be or what effect it has upon performance was notavailable.X1.2 Designs listed enable the surgeon to select from avariety of fixation pins and wires.X1.3 The materials listed represent the current usage andhave demonstrated clinical acceptance in these devices.ASTM International ta

22、kes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own r

23、esponsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addre

24、ssed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at t

25、he address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).FIG. 4 Nut for Hagie PinF366 104