ASTM F366-2004(2009) Standard Specification for Fixation Pins and Wires.pdf

1、Designation: F 366 04 (Reapproved 2009)Standard Specification forFixation Pins and Wires1This standard is issued under the fixed designation F 366; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon () 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

3、pins and wires.1.2 In recognition 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 inch-pound units are to be regardedas standard. The values given in parentheses ar

4、e mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobal

5、t-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 136 Sp

6、ecification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 562 Specification for Wrought 35Cobal

7、t-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)3F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Ni

8、ckel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F 1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nicke

9、l3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants (UNS S31675)3. Materials3.1 Fixation pins and wires shall be fabricated from materialconforming to one of the following ASTM Specifications:F67, F75, F90, F 136, F 138, F 562, F 563, F 1314, F 1537,and F 1586.4. Performance Requ

10、irements4.1 Factors considered to be important, but for which valuesand 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 fabricate

11、d in accordancewith the dimensions illustrated in Figs. 1-4.5.2 Fixation 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 sh

12、all be adequate to protect the fixation pinsand wires during shipment.6.2 Labeling for fixation pins and wires shall include:6.2.1 Product name,6.2.2 Size, on the immediate container,1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and

13、is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved April 1, 2009. Published April 2009. Originallyapproved in 1973. Last previous edition approved in 2004 as F 366 04.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Custo

14、mer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO

15、 Box C700, West Conshohocken, PA 19428-2959, United States.6.2.2.1 Length,6.2.2.2 Diameter (if round) or cross-sectional size (if squareof hexagonal), that is,14 in. (6.4 mm) square, and6.2.3 ASTM material specification Designation number.7. Keywords7.1 fixation materials; flexible surgical wire; or

16、thopaedicmedical devices; wire-surgical implantsNOTE 1Pins and wires may be smooth shank or threaded.NOTE 2Point angle and helix angle, 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 diamete

17、r. Shank diameters on pins largerthan18 in. (3.2 mm) may be reduced.NOTE 4Optional designs, both ends pointed or point with suture hole.FIG. 1 Fixation Pins and WiresF 366 04 (2009)2NOTE 1Shall be made of one piece of material; that is, not an assembly of two or more pieces.NOTE 2Thread major diamet

18、er may be the same or larger than the shaft diameter.NOTE 3Thread length shall be optional to suit intended medical application.NOTE 4Optional marking 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 sh

19、all be optional to suit intended medical application.FIG. 3 Fixation Pin-Hagie TypeF 366 04 (2009)3APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The primary reasons for the revision of this specifi-cation are:X1.1.1 To characterize fixation pins and wires used in thetreatment of fractures or d

20、isease of the skeletal system.X1.1.2 To incorporate fixation pinsKnowles and Hagietypes (Specification F 368).X1.1.3 To specify marking nomenclature.X1.1.4 To add performance requirements in accordancewith Performance Sections request.X1.1.5 To add packaging and labeling.X1.1.6 To remove the dimensi

21、ons 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 requirementshould be or what effect it has upon performance was notavailable.X1.2 Designs listed enable the surgeon to select from avariety

22、of fixation pins and wires.X1.3 The materials listed represent the current usage andhave demonstrated clinical acceptance in these devices.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this s

23、tandard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years

24、andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee

25、, 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 the 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).FIG. 4 Nut for Hagie PinF 366 04 (2009)4