ASTM F366-2017 Standard Specification for Fixation Pins and Wires《固定插脚和固定线缆的标准规格》.pdf

1、Designation: F366 10 (Reapproved 2015)F366 17Standard 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.Anum

2、ber 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 functional dimensions for fixation pins and wires.1.2 In recognition of many broad and varied uses of such pins an

3、d 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 as standard. No other units of measurement are included in this standard.1.4 This international standard was developed in accordance

4、 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

5、ds:2F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F86 Practice for Surface Preparation and Marking of M

6、etallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specificati

7、on for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F368 Specification for Fixation Pins-Knowles and Hagie Types (Withdrawn 1982)3F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Application

8、s(UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical ImplantApplications (UNS R30563) (Withdrawn 2005)3F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium13 Nickel5 Manganese2.5 Molybdenum StainlessSteel Alloy Bar and

9、 Wire for Surgical Implants (UNS S20910)F1537F2503 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)Practice for Marking Medical Devices and Other Items for Safety in the Magnetic ResonanceEnvironmentF1586 Specification for W

10、rought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum StainlessSteel Alloy Bar for Surgical Implants (UNS S31675)3. Materials3.1 Fixation pins and wires shall be fabricated from material conforming to one of the followingASTM Specifications:a metallicmaterial intended for surgical i

11、mplant applications. In addition, the materials shall be biocompatible for the intended application.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.Current edit

12、ion approved March 1, 2015Sept. 1, 2017. Published April 2015October 2017. Originally approved in 1973. Last previous edition approved in 2010 asF366 10.F366 10 (2015). DOI: 10.1520/F0366-10R15. 10.1520/F0366-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Cust

13、omer 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 ASTM standard and is intended only to p

14、rovide 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 all cases only the current versionof t

15、he 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 States1Materials should be chosen based on the design requirements of the particular device.ASTM committee F67,F04.12

16、F75,maintainsF90,a F136,number F138,of F562,metallic F563,material F1314,specifications F1537, andsuitable for F1586.surgical implantapplications.4. Performance Requirements4.1 Factors considered to be important, but for which values and test methods have not been established, are bending strength,f

17、atigue strength, breaking strength (Knowles Type only), torsion strength, and ductility.5. Dimensions and Characteristics5.1 Fixation pins and wires shall be fabricated in accordance with the dimensions illustrated in Figs. 1-4.5.2 Fixation pins and wires shall have surfaces prepared and marked in a

18、ccordance with Practice F86.5.2.1 Optional marking on the fixation pins and wires shall identify the manufacturer or distributor.6. Packaging and Labeling6.1 Packaging shall be adequate to protect the fixation pins and wires during shipment.6.2 Labeling for fixation pins and wires shall include:NOTE

19、 1Pins and wires may be smooth shank or threaded.NOTE 2Point angle and helix angle, where applicable, is as specified by the 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

20、 be reduced.NOTE 4Optional designs, both ends pointed or point with suture hole.FIG. 1 Fixation Pins and WiresF366 172NOTE 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 3Threa

21、d length shall be optional to suit the 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 shall be optional to suit the intended medical application.FIG

22、 3 Fixation Pin-Hagie TypeF366 1736.2.1 Product name,6.2.2 Size, on the immediate container,6.2.2.1 Length,6.2.2.2 Diameter (if round) or cross-sectional size (if square ofor hexagonal), that is, 6.4 mm square, and6.2.3 ASTM material specification Designation number.6.3 Consider Practice F2503 to i

23、dentify 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.7. Keywords7.1 fixation materials; flexible surgical wire; orthopaedic medical devices; wire-surgical implantsAPPENDIX(Nonma

24、ndatory Information)X1. RATIONALEX1.1 The primary reasons for the revision of this specification are:X1.1.1 To characterize fixation pins and wires used in the treatment of fractures or disease of the skeletal system.X1.1.2 To incorporate fixation pinsKnowles and Hagie types (Specification F368).X1.

25、1.3 To specify marking nomenclature.X1.1.4 To add performance requirements in accordance with Performance Sections request.X1.1.5 To add packaging and labeling.X1.1.6 To remove the dimensions on the Crowe since the dimensions are not essential.X1.1.7 Specific surface finish was considered, however,

26、not included, since test data to confirm what the requirement should beor what effect it has upon performance waswere not available.X1.2 Designs listed enable the surgeon to select from a variety of fixation pins and wires.X1.3 The materials listed represent the current usage and have demonstrated c

27、linical acceptance in these devices.FIG. 4 Nut for Hagie PinF366 174ASTM International takes 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

28、 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 andif not revised, either reapproved or withdrawn.Your comments are inv

29、ited 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, which you may attend. If you feel that your comments have not received

30、 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 th

31、is 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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 175