ASTM F366-17 Standard Specification for Fixation Pins and Wires.pdf

1、Designation: 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. A number in parentheses indi

2、cates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers functional dimensions forfixation pins and wires.1.2 In recognition of many broad and varied uses of suchpins and wires, many options a

3、re 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.1.4 This international standard was developed in accor-dance with internationally re

4、cognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F86 Practice for S

5、urface Preparation and Marking of Metal-lic Surgical ImplantsF368 Specification for Fixation Pins-Knowles and HagieTypes (Withdrawn 1982)3F2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment3. Materials3.1 Fixation pins shall be fabricated from a

6、 metallic materialintended for surgical implant applications. In addition, thematerials shall be biocompatible for the intended application.Materials should be chosen based on the design requirementsof the particular device. ASTM committee F04.12 maintains anumber of specifications for materials tha

7、t are suitable forsurgical implant applications.4. Performance Requirements4.1 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. Dimension

8、s 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 shall have surfaces prepared andmarked in accordance with Practice F86.5.2.1 Optional marking on the fixation pins and wires shallidentify the ma

9、nufacturer or distributor.6. Packaging and Labeling6.1 Packaging shall 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,6.2.2.1 Length,6.2.2.2 Diameter (if round) or cros

10、s-sectional size (if squareor hexagonal), that is, 6.4 mm square, and6.2.3 ASTM material specification Designation number.6.3 Consider Practice F2503 to identify potential hazardsproduced by interactions between the device and the MRenvironment and for terms that may be used to label the devicefor s

11、afety in the MR environment.7. Keywords7.1 fixation materials; flexible surgical wire; orthopaedicmedical devices; wire-surgical implants1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F0

12、4.21 on Osteosynthesis.Current edition approved Sept. 1, 2017. Published October 2017. Originallyapproved in 1973. Last previous edition approved in 2010 as F366 10 (2015).DOI: 10.1520/F0366-17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at s

13、erviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken

14、, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organizati

15、on Technical Barriers to Trade (TBT) Committee.1NOTE 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 dia

16、meter. Shank diameters on pins largerthan 3.2 mm may 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 th

17、e same or larger than the shaft diameter.NOTE 3Thread 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 o

18、ptional to suit the intended medical application.FIG. 3 Fixation Pin-Hagie TypeF366 173APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The primary reasons for this specification are:X1.1.1 To characterize fixation pins and wires used in thetreatment of fractures or disease of the skeletal system

19、.X1.1.2 To incorporate fixation pinsKnowles and Hagietypes (Specification F368).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 thedime

20、nsions 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 were notavailable.X1.2 Designs listed enable the surgeon to select from avariety of fixation pins and wires.X1

21、.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 standard are expressly advised

22、 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 andif not revised, either rea

23、pproved 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, which you may attend. If yo

24、u 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

25、 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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 4 Nut for Hagie PinF366 174