ASTM F366-2004 Standard Specification for Fixation Pins and Wires《固定销钉及金属丝的标准规范》.pdf

1、Designation: F 366 04Standard 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 in parentheses in

2、dicates the year of last reapproval. Asuperscript epsilon (e) 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.

3、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 the standard. The values given in parentheses are providedfor

4、 information only.2. Referenced Documents2.1 ASTM Standards:2F 67 Specification for Unalloyed Titanium for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F 75 Specification for Cobalt-28Chromium-6MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075

5、)F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy f

6、or SurgicalImplant Applications (UNS R56401)F 138 Specification for Wought-18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 562 Specification for Wrought Cobalt-35 Nickel-20Chromium-10 Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 56

7、3 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stain-less Steel Alloy Bar and Wire for Surgical Implants (UNS

8、S20910)F 1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloy for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F 1586 Specification for Wrought Nitrogen Strengthened21Chromium-10Nickel-3Manganese-2.5!MolybdenumStainless Steel Bar for Surgical Implants (UNS S31675)3. Materia

9、ls3.1 Fixation pins and wires shall be fabricated from materialconforming to one of the following ASTM Specifications:F 67, F 75, F 90, F 136, F 138, F 562, F 563, F 1314, F 1537,and F 1586.4. Performance Requirements4.1 Factors considered to be important, but for which valuesand test methods have n

10、ot 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 Fixation pins and wires sha

11、ll have surfaces prepared andmarked in accordance with Practice F 86.5.2.1 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.6.2 Labeling for fix

12、ation pins and wires shall include:6.2.1 Product name,6.2.2 Size, on the immediate container,6.2.2.1 Length,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.Curren

13、t edition approved Oct. 1, 2004. Published October 2004. Originallyapproved in 1973. Last previous edition approved in 2000 as F 366 82 (2000).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards vo

14、lume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.2.2.2 Diameter (if round) or cross-sectional size (if squareof hexagonal), that is,14 in. (6.4 mm) sq

15、uare, 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, where applicable, is as specified by manu

16、facturer.NOTE 3On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. 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 WiresF366042NOTE

17、 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 in this location.FIG. 2 Fixation Pi

18、n-Knowles TypeF366043APPENDIX(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 disease of the skeletal system.X1.1.2 To incorporate fixation pinsKnowles and H

19、agietypes (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 dimensions on the Crowe since thedimensions are not essential.X1.1.7 Specific surface

20、 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 of fixation pins and wires.X1.3 The materials listed represent the current usa

21、ge andhave demonstrated clinical acceptance in these devices.NOTE 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 TypeFIG. 4 Nut for Hagie PinF366044ASTM International takes

22、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 respo

23、nsibility.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 addressed

24、 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 the a

25、ddress 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).F366045