ASTM F2180-2002(2015) Standard Specification for Metallic Implantable Strands and Cables《外科植入用金属绞合线和电缆的标准规格》.pdf

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1、Designation: F2180 02 (Reapproved 2015)Standard Specification forMetallic Implantable Strands and Cables1This standard is issued under the fixed designation F2180; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last re

2、vision. A number 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 covers the materials, dimensionaltolerances, constructions, and mechanical properties for stan-dard metall

3、ic implantable strands and cables.1.2 This specification is intended to assist in the develop-ment of specific strand and cable specifications. It is particu-larly appropriate for high load bearing applications. It is notintended however, to address all of the possible variations inconstruction, mat

4、erial, or properties.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for Tension Testing of Metallic MaterialsF86 Practice for Surface Preparation and Marking of Met

5、al-lic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)F138 Specificati

6、on for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F1058 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nick

7、el-7Molybdenum Alloy Wire and Strip forSurgical Implant Applications (UNS R30003 and UNSR30008)F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F1314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 Molybd

8、enumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1341 Specification for Unalloyed Titanium Wire UNSR50250, UNS R50400, UNS R50550, UNS R50700, forSurgical Implant Applications (Withdrawn 2006)32.2 American Society for Quality (ASQ) Standard:4ASQ C1 Specification of General Re

9、quirements for a Qual-ity Program2.3 Department of Defense Specifications:5MIL-DTL-83420J Wire Rope, Flexible, ForAircraft ControlMIL-DTL-83420/1B Wire Rope, Flexible, Type 1, Compo-sition AMIL-DTL-83420/2B Wire Rope, Flexible, Type 1, Compo-sition B3. Terminology3.1 Definitions:3.1.1 cable, na grou

10、p of strands helically twisted together.3.1.2 diameter, nthe distance between opposing pointsacross the circle circumscribing either the strand or cable asillustrated in Figs. 1 and 2 (see MIL-DTL-83420J, MIL-DTL-83420/1B and MIL-DTL-83420/2B).3.1.3 lay (or twist), nthe helical form taken by the wir

11、es ina strand and by the strands in a cable (see MIL-DTL-83420J).3.1.3.1 DiscussionIn a “Right Lay” situation, the wires ofthe strand (or the strands in a cable) are oriented in the samedirection as the thread on a right-hand screw.3.1.4 length of lay (or pitch), nthe distance parallel to theaxis of

12、 the strand (or cable) in which a wire (or strand) makesone complete turn about the axis.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.Current edition approved

13、Sept. 1, 2015. Published October 2015. Originallyapproved in 2002. Last previous edition approved in 2011 as F2180 02 (2011)1.DOI: 10.1520/F2180-02R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStan

14、dards 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.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available f

15、rom DODSSP, Building 4, Section D, 700 Robbins Ave.,Philadelphia, PA 191115098.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.5 MN, nthe construction designation for strands andcables. In this construction designation M represent

16、s thenumber of strands in the cable and N represents the number ofwires in each strand.3.1.5.1 Discussion Some examples of strand construc-tions are 17 and 13. Similar examples of cable constructionsare 77 and 719.3.1.6 strand, na group of wires helically twisted together.3.1.7 wire, nan individual

17、element (typically a cylindricalrod) making up a strand.4. General Requirements4.1 In addition to the requirements of this specification, allrequirements of the current editions of Specifications F90,F136, F138, F562, F1058, F1295, F1314, and F1341 shallapply.4.2 In cases of conflict between this sp

18、ecification and thoselisted in 2.1, this specification shall take precedence.5. Ordering Information5.1 Inquiries and orders under this specification shall in-clude the following information:5.1.1 Quantity (weight, length, or number of pieces),5.1.2 ASTM designation,5.1.3 Material (ASTM designation)

19、,5.1.4 Condition,5.1.5 Construction,5.1.6 Applicable dimensions (including diameter, length(s)of lay, and length),5.1.7 Mechanical properties (including breaking force),5.1.8 Special requirements, and5.1.9 Special tests.6. Materials and Manufacture6.1 WiresImplantable strands and cables shall be man

20、u-factured using equivalent size wires.6.2 ConditionImplantable strands and cables shall besupplied in the cold-worked, cold-worked and stress-relieved,or annealed condition.6.3 FinishTypes of finish available in strands and cablesare cold-drawn, pickled, swaged, or as specified by thecustomer.FIG.

21、1 Standard Stranding ConstructionsFIG. 2 Standard Cabling ConstructionsF2180 02 (2015)27. Stranding7.1 The standard strand constructions are illustrated in Fig.1. These constructions are described in the following manner:7.1.1 13 StrandThis construction is characterized by aleft-hand lay with a unif

22、orm pitch of 4 to 10 times the nominalstrand diameter.7.1.2 17 StrandThis construction is characterized by aleft-hand lay with a uniform pitch of 8 to 16 times the nominalstrand diameter.7.1.3 119 StrandThis construction is characterized by aninner 17 strand with a right-hand lay and a uniform pitch

23、 of8 to 12 times the nominal strand diameter. The outer 12 wireshave a left-hand lay with a uniform pitch of 9 to 11 times thenominal strand diameter.7.2 Strands may be ordered to constructions other than thosespecified above as determined by the customer and supplier.8. Cabling8.1 The standard cabl

24、ing constructions are illustrated in Fig.2. These constructions are described in the following manner.8.1.1 77 CableThis construction is characterized by aninner 17 strand that has a right-hand lay with a uniform pitchof 12 to 16 times the nominal strand diameter. The outer 17strands have a left-han

25、d lay with a uniform pitch of 8 to 16times the nominal strand diameter. Overall, the 77 cable hasa right-hand lay with a uniform pitch of 7 to 10 times thenominal cable diameter.8.1.2 719 CableThe construction is composed of a core119 strand where the inner 7 wire strand has a right-hand laywith a u

26、niform pitch of 12 to 16 times the nominal stranddiameter. The remaining outer 12 wires of the core 119 strandhave a right-hand lay with a uniform pitch of 9 to 11 times thenominal strand diameter. The outer 119 stands of this con-figuration have an inner 7 wire strand that has a left-hand laywith a

27、 uniform pitch of 8 to 16 times the nominal stranddiameter. The remaining outer 12 wires of the outer 119strands have a left-hand lay with a uniform pitch of 9 to 11times the nominal strand diameter. Overall, the 719 cable hasa right-hand lay with a uniform pitch of 7 to 10 times thenominal cable di

28、ameter.8.2 Cables may be ordered to constructions other than thosespecified above as determined by the customer and supplier.9. Joints9.1 There shall be no welds or splices in the completedstrand or cable except at terminal ends.10. Dimensional Requirements10.1 Strands and cables shall be fabricated

29、 in accordancewith the dimensions and tolerances specified in Table 1.11. Mechanical Requirements11.1 Test strands and cables shall be in accordance with TestMethod E8. When tensile testing strands and cables, use agauge length of 254 mm.11.2 Use the following formulas for determining the effec-tive

30、 cross-sectional area for standard construction strands orcables being tested (see section X1.4). The variable “D” ineach equation is the measured diameter of the strand or cable.11.2.1 13 strand3(D/4.15)2.11.2.2 17 strand7(D/6)2.11.2.3 119 strand19(D/10)2.11.2.4 77 cable49(D/18)2.11.2.5 719 cable13

31、3(D/30)2.11.3 Calculate the minimum breaking force for standardconstruction strands and cables by multiplying the materialstensile strength found in Table 2 times the stand or cable areaas determined by the formulas in 11.2.11.3.1 Table 2 specifies mechanical requirements for strandsand cables of st

32、andard construction. The supplier and customershall determine mechanical requirements for non-standard,swaged, or drawn strands and cables.11.4 Verify that all tested strands and cable samples meetthe minimum breaking force.12. Surface Finish and Handling12.1 The surface of strands and cables confor

33、ming to thisspecification shall be free of imperfections such as tool marks,nicks, scratches, cracks, cavities, spurs, die marks, and otherdefects that would impair the serviceability of the wire. Thesurface shall be free of embedded or deposited finishingmaterials and other undesirable contaminants

34、.12.2 Finish operations such as drawing or swaging may beperformed on the strands or cables as specified by the cus-tomer.TABLE 1 Dimensional Requirements for Metallic ImplantableStrands and CablesSpecified Diameter,mmDiameter Tolerance,mmOut-of-Round Tolerance,mmUnder 0.12 0.0075 0.00750.12 to unde

35、r 0.20 0.015 0.0150.20 to under 0.30 0.022 0.0220.30 to under 0.60 0.030 0.0300.60 to under 0.82 0.037 0.0370.82 to under 1.10 0.060 0.0601.10 to under 2.50 0.075 0.0752.50 to under 4.10 0.150 0.150TABLE 2 Mechanical Requirement for Metallic ImplantableStrands and CablesASTM Material ConditionUltima

36、te TensileStrength min.MPaF90 Annealed 860F136 Annealed 860F138 AnnealedCold-worked490860F562 AnnealedCold-worked7931793F1058 Cold-worked 1515F1295 Annealed 900F1314 AnnealedCold-worked6901035F1341 Grade 1 Annealed 240F1341 Grade 2 Annealed 345F1341 Grade 3 Annealed 450F1341 Grade 4 Annealed 550F218

37、0 02 (2015)312.3 The strands or cables may be subjected to a passivationprocess if requested by the customer. Such passivation processshall be performed in accordance with Practice F86.12.4 The strands or cables shall be handled with care andpackaged adequately to prevent damage and contamination of

38、the surface during transport and storage.13. Certification13.1 The manufacturers certification that the material wasmanufactured and tested in accordance with this specificationand that strands and cables of standard construction meet therequirements of this specification (including a report of the

39、testresults) shall be furnished at the time of product shipment.14. Quality Program Requirements14.1 The producer shall maintain a quality program, such asthat defined in ASQ C1.14.2 The manufacturer of surgical implants may audit theproducers quality program for conformance to the intent ofASQ C1 o

40、r other recognized program.15. Keywords15.1 cable; cobalt alloys; metal (for surgical implants);stainless steel; strand; surgical implants; titanium/titaniumalloy; wire; 316LAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The primary purpose of this specification is to char-acterize the material

41、s, dimensional tolerances, construction,and mechanical properties of commonly used strands andcables for implant applications.X1.2 Tensile strength properties are included in this speci-fication in order to characterize the relative mechanical prop-erties exhibited by the various materials.X1.3 Due

42、to the vast number of cabling configurations andpossible cable and strand diameters available, this specificationrelies upon the calculation of the breaking force instead ofsupplying an extensive tabular listing.X1.4 The effective cross-sectional area of the strand orcable as determined in 11.2 is c

43、alculated in a manner that usesa relationship between the measured cable or strand diameterand the diameter of the individual wires. For example, asshown in Fig. 1 for the 17 strand, the diameter of the strandis composed of three individual wires. Therefore, the formulafor the effective strand area

44、in 11.2.2 divides the stranddiameter by the number of wires across the diameter of thestrand (n=3) in order to determine the wire diameter and thenby two (2) in order to determine the wire radius. The effectivecross-sectional area for the strand is then the number of wiresin the strand (n =7) times

45、the wire area.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 that determination of the validity of any such patent rights, and the riskof infringement of su

46、ch 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 invited either for revision of this standard or for addi

47、tional 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 a fair hearing you shouldmake your views known to th

48、e 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

49、 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:/ 02 (2015)4