ASTM F1611-2000(2018) Standard Specification for Intramedullary Reamers《髓内扩髓器标准规范》.pdf

1、Designation: F1611 00 (Reapproved 2018)Standard Specification forIntramedullary Reamers1This standard is issued under the fixed designation F1611; 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.1. Scope1.1 This specification provides requirements for material,dimensions and tolerances, finish and marking, and care andhandling for reamers intended

3、 to cut a cylindrical path alongthe medullary canal of diaphyseal bone.1.2 Intramedullary reamers are commonly used to preparethe medullary canal for the insertion of intramedullary fixationdevices (IMFD). As such, the relationship between the in-tramedullary reamer diameter and the IMFDs diameter a

4、reconsidered.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 recognized principles on standard-ization established in the Decision on Principl

5、es 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:2A564/A564M Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and

6、ShapesA693 Specification for Precipitation-Hardening Stainlessand Heat-Resisting Steel Plate, Sheet, and StripA705/A705M Specification for Age-Hardening StainlessSteel ForgingsF86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF565 Practice for Care and Handling of Orthop

7、edic Implantsand InstrumentsF899 Specification for Wrought Stainless Steels for SurgicalInstrumentsF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1264 Specification and Test Methods for IntramedullaryFixation Devices3. Terminology3.1 Definitions of Terms Specific to This Stan

8、dard:3.1.1 cutting head, nthe portion of the reamer, whichconsists of flutes, or edges, which cut the bone.3.1.2 reamer diameter, nthe diameter of the circumscribedcircle of the cutting heads cross-section (shown in Fig. 1).3.1.3 reamer shaft diameter, nthe diameter of the circum-scribed circle of t

9、he long portion of the reamer, which connectsthe cutting portion of the reamer to the drill.4. Classification4.1 In general, intramedullary reamers consist of two types:4.1.1 One-piece reamerA design where the reamer shaftand cutting head are permanently attached to each other.4.1.2 Modular ReamerA

10、design where the reamer shaftand cutting head are two separate components, fixed to eachother temporarily at the time of use via a geometric connection,for example, dovetail joint.5. Dimensions and Tolerances5.1 The reamer diameter shall be measured at the largestportion of the cutting heads cross s

11、ection and reported to thenearest 0.2 mm. The reamer diameter shall be measured usinga micrometer or an appropriate ring gage. When using amicrometer to measure reamers with an odd number of flutes,a V-anvil micrometer (with the appropriate angle, based on thenumber of flutes) will be used to accura

12、tely determine thereamer diameter.5.2 The tolerance of a reamer diameter shall be no morethan 60.075 mm.6. Material Requirements6.1 The reamers shaft and cutting head shall be fabricatedfrom materials with suitable strength, hardness, and corrosionresistance. The materials described in Specification

13、s A564/A564M, A693, A705/A705M, and F899 have been found to besuitable for this use.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibliltiy ofSubcommittee F04.21 on Osteosynthesis.Current edition approved Feb.

14、 1, 2018. Published April 2018. Originallyapproved in 1995. Last previous edition approved in 2013 as F1611 00(2013).DOI: 10.1520/F1611-00R18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards vol

15、ume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on stan

16、dardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.17. Finish and Marking7.1 The shaft and cutting head shall be free from burrs,nicks, dent

17、s, and scratches when examined in accordance withPractice F86.7.2 The flutes of the cutting head will be of the appropriategeometry to perform the intended use of reaming bone.7.3 When space permits, the following information shouldbe legibly marked on the reamer (in order of preference):7.3.1 Reame

18、r diameter,7.3.2 Manufacturers name or logo,7.3.3 Catalog number,7.3.4 Reamer shaft diameter, if the shaft diameter is notuniform along its length, for example, a tapered shaft, then themaximum and minimum diameters should be given.7.3.5 Manufacturing lot number.7.4 Reamers shall be marked in accord

19、ance with PracticeF983 when practical, unless otherwise specified in 7.3.8. Care and Handling8.1 The reamer should be cared for and handled in accor-dance with Practice F565, as appropriate.8.2 The flutes of the cutting head should be checkedperiodically for damage or wear. Reamers that are consider

20、edto be performing inadequately should be removed from ser-vice.NOTE 1No standards exist for the measurement of “sharpness.”Reamer performance is the most reliable method for assessing reamersharpness.9. Keywords9.1 intramedullary fixation device; orthopaedic medical de-vice; reamer; surgical instru

21、mentsAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 Intramedullary reamers commonly are used to preparethe medullary canal for the subsequent insertion of an IMFD.The relationship between the diameter of the hole prepared bythe reamer and the IMFDs diameter are important in relationto the fit a

22、chieved by the implant in the bone and the avoidanceof surgical complications. If the fit is too loose, the initialfixation may be inadequate to control the translation of thefragments. If the fit is too tight, it may be impossible to drivethe IMFD into the bone, the bone fragments may burst, theIMF

23、D may migrate out through the side of the bone, and soforth. It is important that the designation for the reamer size ordiameter be related to the diameter of the reamers cuttingflutes so that instruments and IMFDs of different designs andmanufacturers can be interchanged during use. Using thereamer

24、 diameter specified here and the IMFD diameter speci-fied in Specification F1264, the surgeon may have confidencein achieving the correct reamer/IMFD geometric relationship.X1.2 The reamer shaft diameter may be an importantdimension in the clinical use of the intramedullary reamer.Laboratory studies

25、 have suggested that larger reamer shaftdiameters result in greater intramedullary pressure.3,4,53Muller, C.A., Schavan, R., Frigg, R., Perren, S.M., and Pfister, U., “Intramed-ullary Pressure Increase for Different Commercial and Experimental ReamingSystems: An Experimental Investigation,” Journal

26、of Orthopaedic Trauma, Vol 12,No. 8, pp. 54046, 1998.4Peter, R.E., Selz, T., and Koesti, A., “Influence of the Reamer Shape onIntraosseous Pessure During Closed Intramedullary Nailing of the Unbroken Femur:A Preliminary Report,” Injury, Vol 24, Suppl. 3, pp. S4855, 1993.5Muller, C.A., Frigg, R., and

27、 Pfister, U., “Can Modifications to Reamer andFlexible Shaft Design Decrease Intramedullary Pressure During Reaming? AnExperimental Investigation,” Techniques in Orthopaedics, Vol 11, No. 1, pp. 1827,1996.FIG. 1 Reamer Cutting HeadF1611 00 (2018)2ASTM International takes no position respecting the v

28、alidity 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 responsibility.This standard is s

29、ubject 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 to ASTM International Headq

30、uarters. 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 address shown below.This stan

31、dard 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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 00 (2018)3