ASTM F2180-2002(2007)e2 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范》.pdf

1、Designation: F 2180 02 (Reapproved 2007)2Standard Specification forMetallic Implantable Strands and Cables1This standard is issued under the fixed designation F 2180; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、 revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTESection 3 and paragraphs 11.1 and 12.4 were editorially corrected in February 2007.2NOTEUnits information was editorially correct

3、ed in August 2009.1. Scope1.1 This specification covers the materials, dimensionaltolerances, constructions, and mechanical properties for stan-dard metallic implantable strands and cables.1.2 This specification is intended to assist in the develop-ment of specific strand and cable specifications. I

4、t is particu-larly appropriate for high load bearing applications. It is notintended however, to address all of the possible variations inconstruction, material, or properties.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.

5、2. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for Tension Testing of Metallic MaterialsF86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)

6、F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 562 Specification for Wrought

7、 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 1058 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip forSurgical Implant Applications (UNS R30003 and UNSR30008)F 1295 Specification for Wrought Titanium-6Al

8、uminum-7Niobium Alloy for Surgical Implant Applications (UNSR56700)F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1341 Specification for Unalloyed Titanium Wire UNSR50250, UNS

9、 R50400, UNS R50550, UNS R50700, forSurgical Implant Applications32.2 American Society for Quality (ASQ) Standard:4ASQ C1 Specification of General Requirements for a Qual-ity Program2.3 Department of Defense Specifications:5MIL-DTL-83420J Wire Rope, Flexible, For Aircraft Con-trolMIL-DTL-83420/1B Wi

10、re 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 group of strands helically twisted together.3.1.2 diameter, nthe distance between opposing pointsacross the circle circumscribing either the strand or ca

11、ble 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 wiresin a strand and by the strands in a cable (see MIL-DTL-83420J).1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Su

12、rgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved Feb. 1, 2007. Published February 2007. Originallyapproved in 2002. Last previous edition approved in 2002 as F 2180 02.2For referenced ASTM standards, visit the ASTM website

13、, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.4Available from the

14、American Society for Quality (ASQ), 600 N. PlankintonAve., Milwaukee, WI 53203.5Available from DODSSP, Building 4, Section D, 700 Robbins Ave., Philadel-phia, PA 191115098.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.3.1 Discu

15、ssionIn 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 the strand (or cable) in which a wire (or strand) makesone complete turn abou

16、t the axis.3.1.5 M3N, nthe construction designation for strands andcables. In this construction designation M represents 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 137 and 133. Similar examples of

17、 cable construc-tions are 737 and 7319.3.1.6 strand, na group of wires helically twisted together.3.1.7 wire, nan individual element (typically a cylindricalrod) making up a strand.4. General Requirements4.1 In addition to the requirements of this specification, allrequirements of the current editio

18、ns of Specifications F90,F 136, F 138, F 562, F 1058, F 1295, F 1314, and F 1341 shallapply.4.2 In cases of conflict between this specification and thoselisted in 2.1, this specification shall take precedence.5. Ordering Information5.1 Inquiries and orders under this specification shall in-clude the

19、 following information:5.1.1 Quantity (weight, length, or number of pieces),5.1.2 ASTM designation,5.1.3 Material (ASTM designation),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)

20、,5.1.8 Special requirements, and5.1.9 Special tests.6. Materials and Manufacture6.1 WiresImplantable strands and cables shall be manu-factured using equivalent size wires.FIG. 1 Standard Stranding ConstructionsFIG. 2 Standard Cabling ConstructionsF 2180 02 (2007)226.2 ConditionImplantable strands an

21、d 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 customer.7. Stranding7.1 The standard strand constructions are illustrated in Fig.1. These

22、constructions are described in the following manner:7.1.1 133 StrandThis construction is characterized by aleft-hand lay with a uniform pitch of 4 to 10 times the nominalstrand diameter.7.1.2 137 StrandThis construction is characterized by aleft-hand lay with a uniform pitch of 8 to 16 times the nom

23、inalstrand diameter.7.1.3 1319 StrandThis construction is characterized byan inner 137 strand with a right-hand lay and a uniform pitchof 8 to 12 times the nominal strand diameter. The outer 12wires have a left-hand lay with a uniform pitch of 9 to 11 timesthe nominal strand diameter.7.2 Strands may

24、 be ordered to constructions other than thosespecified above as determined by customer and supplier.8. Cabling8.1 The standard cabling constructions are illustrated in Fig.2. These constructions are described in the following manner.8.1.1 737 CableThis construction is characterized by aninner 137 st

25、rand that has a right-hand lay with a uniform pitchof 12 to 16 times the nominal strand diameter. The outer 137strands have a left-hand lay with a uniform pitch of 8 to 16times the nominal strand diameter. Overall, the 737 cable hasa right-hand lay with a uniform pitch of 7 to 10 times thenominal ca

26、ble diameter.8.1.2 7319 CableThe construction is composed of a core1319 strand where the inner 7 wire strand has a right-hand laywith a uniform pitch of 12 to 16 times the nominal stranddiameter. The remaining outer 12 wires of the core 1319strand have a right-hand lay with a uniform pitch of 9 to 1

27、1times the nominal strand diameter. The outer 1319 stands ofthis configuration have an inner 7 wire strand that has aleft-hand lay with a uniform pitch of 8 to 16 times the nominalstrand diameter. The remaining outer 12 wires of the outer1319 strands have a left-hand lay with a uniform pitch of 9 to

28、11 times the nominal strand diameter. Overall, the 7319 cablehas a right-hand lay with a uniform pitch of 7 to 10 times thenominal cable diameter.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

29、 or splices in the completedstrand or cable except at terminal ends.10. Dimensional Requirements10.1 Strands and cables shall be fabricated in accordancewith the dimensions and tolerances specified in Table 1.11. Mechanical Requirements11.1 Test strands and cables shall be in accordance with TestMet

30、hod E8. When tensile testing strands and cables, use agauge length of 254 mm.11.2 Use the following formulas for determining the effec-tive cross-sectional area for standard construction strands orcables being tested (see section X1.4). The variable “D” ineach equation is the measured diameter of th

31、e strand or cable.11.2.1 133 strand3p(D/4.15)2.11.2.2 137 strand7p(D/6)2.11.2.3 1319 strand19p(D/10)2.11.2.4 737 cable49p(D/18)2.11.2.5 7319 cable133p(D/30)2.11.3 Calculate the minimum breaking force for standardconstruction strands and cables by multiplying the materialstensile strength found in Ta

32、ble 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 standard construction. The supplier and customershall determine mechanical requirements for non-standard,swaged, or drawn strands and cables.11.4 Verify

33、that all tested strands and cable samples meetthe minimum breaking force.12. Surface Finish and Handling12.1 The surface of strands and cables conforming to thisspecification shall be free of imperfections such as tool marks,nicks, scratches, cracks, cavities, spurs, die marks, and otherdefects that

34、 would impair the serviceability of the wire. TheTABLE 1 Dimensional Requirements for Metallic ImplantableStrands and CablesSpecified Diameter,mmDiameter Tolerance,6mmOut-of-Round Tolerance,mmUnder 0.12 0.0075 0.00750.12 to under 0.20 0.015 0.0150.20 to under 0.30 0.022 0.0220.30 to under 0.60 0.030

35、 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 ConditionUltimate Tensile Strength min.MPaF90 Annealed 860F 136 Annealed 860F 138 Annea

36、ledCold-worked490860F 562 AnnealedCold-worked7931793F 1058 Cold-worked 1515F 1295 Annealed 900F 1314 AnnealedCold-worked6901035F 1341 Grade 1 Annealed 240F 1341 Grade 2 Annealed 345F 1341 Grade 3 Annealed 450F 1341 Grade 4 Annealed 550F 2180 02 (2007)23surface shall be free of embedded or deposited

37、finishingmaterials and other undesirable contaminants.12.2 Finish operations such as drawing or swaging may beperformed on the strands or cables as specified by the cus-tomer.12.3 The strands or cables may be subjected to a passivationprocess if requested by the customer. Such passivation processsha

38、ll 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 ofthe surface during transport and storage.13. Certification13.1 The manufacturers certification that the material wasmanufactured and test

39、ed in accordance with this specificationand that strands and cables of standard construction meet therequirements of this specification (including a report of the testresults) shall be furnished at the time of product shipment.14. Quality Program Requirements14.1 The producer shall maintain a qualit

40、y program, such asdefined in ASQ C1.14.2 The manufacturer of surgical implants may audit theproducers quality program for conformance to the intent ofASQ C1 or other recognized program.15. Keywords15.1 cable; cobalt alloys; metal (for surgical implants);stainless steel; strand; surgical implants; ti

41、tanium/titaniumalloy; wire; 316LAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The primary purpose of this specification is tocharacterize the materials, dimensional tolerances, construc-tion, and mechanical properties, of commonly used strands andcables for implant applications.X1.2 Tensile st

42、rength properties are included in this speci-fication in order to characterize the relative mechanical prop-erties exhibited by the various materials.X1.3 Due to the vast number of cabling configurations andpossible cable and strand diameters available, this specificationrelies upon the calculation

43、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 calculated in a manner that usesa relationship between the measured cable or strand diameterand the diameter of the individual wires. For exam

44、ple, asshown in Fig. 1 for the 137 strand, the diameter of the strandis composed of three individual wires. Therefore, the formulafor the effective strand area 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 a

45、nd 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 the wire area.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentione

46、din 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 subject to revision at any time by the responsible technical committee and

47、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 Headquarters. Your comments will receive careful consideration at a meeting of

48、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 standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C

49、700, 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).F 2180 02 (2007)24