ASTM F2180-2017 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)F2180 17Standard 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

2、 last revision. 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, dimensional tolerances, constructions, and mechanical properties for standar

3、dmetallic implantable strands and cables.1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularlyappropriate for high load bearing applications. It is not intended however, to address all of the possible variations in constructio

4、n,material, or properties.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 with internationally recognized principles on standardizationestablished in the Decision

5、 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 Standards:2E8 Test Methods for Tension Testing of Metallic MaterialsF86 Practice for Surface Pre

6、paration and Marking of Metallic 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 (UN

7、S R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications(UNS R30035)F1058 Specification for Wrought 40Cobalt

8、-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar forSurgical Implant Applications (UNS R30003 and UNS R30008)F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)F1314 Specification for Wrought Nitrogen Strengthened 2

9、2 Chromium13 Nickel5 Manganese2.5 Molybdenum StainlessSteel Alloy Bar and Wire for Surgical Implants (UNS S20910)F1341 Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for SurgicalImplant Applications (Withdrawn 2006)3F2503 Practice for Marking Medical Device

10、s and Other Items for Safety in the Magnetic Resonance Environment2.2 American Society for Quality (ASQ) Standard:ISO Standards:4ASQ C1ISO 9001 Specification of General Requirements for a Quality ProgramQuality Management SystemsRequirements1 This specification is under the jurisdiction of ASTM Comm

11、ittee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Current edition approved Sept. 1, 2015Feb. 1, 2017. Published October 2015March 2017. Originally approved in 2002. Last previous edition approved in 20112015 asF2180 02 (2

12、011)(2015).1. DOI: 10.1520/F2180-02R15.10.1520/F2180-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The

13、 last approved version of this historical standard is referenced on www.astm.org.4 Available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve., Milwaukee, WI 53203, http:/www.asq.org.National Standards Institute (ANSI), 25 W. 43rdSt., 4th Floor, New York, NY 10036, http:/www.ansi.org.Thi

14、s document is not an ASTM standard and is intended only to provide 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 editio

15、ns as appropriate. In all cases only the current versionof the 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 States12.3 Department of Defense Specifications:5MIL-DTL-8

16、3420J Wire Rope, Flexible, For Aircraft ControlMIL-DTL-83420/1B Wire Rope, Flexible, Type 1, Composition AMIL-DTL-83420/2B Wire Rope, Flexible, Type 1, Composition B3. Terminology3.1 Definitions:3.1.1 cable, na group of strands helically twisted together.3.1.2 diameter, nthe distance between opposin

17、g points across the circle circumscribing either the strand or cable as illustratedin 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 wires in a strand and by the strands in a cable (see MIL-DTL-83420J).3.1.3.1 Discussion

18、In a “Right Lay” situation, the wires of the strand (or the strands in a cable) are oriented in the same direction as the thread ona right-hand screw.3.1.4 length of lay (or pitch), nthe distance parallel to the axis of the strand (or cable) in which a wire (or strand) makes onecomplete turn about t

19、he axis.3.1.5 MN, nthe construction designation for strands and cables. In this construction designation M represents the numberof strands in the cable and N represents the number of wires in each strand.3.1.5.1 DiscussionSome examples of strand constructions are 17 and 13. Similar examples of cable

20、 constructions are 77 and 719.3.1.6 strand, na group of wires helically twisted together.3.1.7 wire, nan individual element (typically a cylindrical rod) making up a strand.4. General Requirements4.1 In addition to the requirements of this specification, all requirements of the current editions of S

21、pecifications F90, F136,F138, F562, F1058, F1295, F1314, and F1341 shall apply.4.2 In cases of conflict between this specification and those listed in 2.1, this specification shall take precedence.5. Ordering Information5.1 Inquiries and orders under this specification shall include the following in

22、formation:5.1.1 Quantity (weight, length, or number of pieces),5.1.2 ASTM designation,5.1.3 Material (ASTM designation),5 Available from DODSSP, Building 4, Section D, 700 Robbins Ave., Philadelphia, PA 191115098.FIG. 1 Standard Stranding ConstructionsF2180 1725.1.4 Condition,5.1.5 Construction,5.1.

23、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 manufactured using equivalent size wires.6

24、.2 ConditionImplantable strands and cables shall be supplied in the cold-worked, cold-worked and stress-relieved, orannealed condition.6.3 FinishTypes of finish available in strands and cables are cold-drawn, pickled, swaged, or as specified by the customer.7. Stranding7.1 The standard strand constr

25、uctions are illustrated in Fig. 1. These constructions are described in the following manner:7.1.1 13 StrandThis construction is characterized by a left-hand lay with a uniform pitch of 4 to 10 times the nominal stranddiameter.7.1.2 17 StrandThis construction is characterized by a left-hand lay with

26、 a uniform pitch of 8 to 16 times the nominal stranddiameter.7.1.3 119 StrandThis construction is characterized by an inner 17 strand with a right-hand lay and a uniform pitch of 8to 12 times the nominal strand diameter. The outer 12 wires have a left-hand lay with a uniform pitch of 9 to 11 times t

27、he nominalstrand diameter.7.2 Strands may be ordered to constructions other than those specified above as determined by the 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 77 CableThis c

28、onstruction is characterized by an inner 17 strand that has a right-hand lay with a uniform pitch of12 to 16 times the nominal strand diameter. The outer 17 strands have a left-hand lay with a uniform pitch of 8 to 16 times thenominal strand diameter. Overall, the 77 cable has a right-hand lay with

29、a uniform pitch of 7 to 10 times the nominal cablediameter.8.1.2 719 CableThe construction is composed of a core 119 strand where the inner 7 wire strand has a right-hand lay witha uniform pitch of 12 to 16 times the nominal strand diameter. The remaining outer 12 wires of the core 119 strand have a

30、right-hand lay with a uniform pitch of 9 to 11 times the nominal strand diameter. The outer 119 stands of this configuration havean inner 7 wire strand that has a left-hand lay with a uniform pitch of 8 to 16 times the nominal strand diameter. The remainingouter 12 wires of the outer 119 strands hav

31、e a left-hand lay with a uniform pitch of 9 to 11 times the nominal strand diameter.Overall, the 719 cable has a right-hand lay with a uniform pitch of 7 to 10 times the nominal cable diameter.8.2 Cables may be ordered to constructions other than those specified above as determined by the customer a

32、nd supplier.FIG. 2 Standard Cabling ConstructionsF2180 1739. Joints9.1 There shall be no welds or splices in the completed strand or cable except at terminal ends.10. Dimensional Requirements10.1 Strands and cables shall be fabricated in accordance with the dimensions and tolerances specified in Tab

33、le 1.11. Mechanical Requirements11.1 Test strands and cables shall be in accordance with Test Method E8. When tensile testing strands and cables, use a gaugelength of 254 mm.11.2 Use the following formulas for determining the effective cross-sectional area for standard construction strands or cables

34、being tested (see section X1.4). The variable “D” in each equation is the measured diameter of the strand or cable.11.2.1 13 strand3pi(D/4.15)2.11.2.2 17 strand7pi(D/6)2.11.2.3 119 strand19pi(D/10)2.11.2.4 77 cable49pi(D/18)2.11.2.5 719 cable133pi(D/30)2.11.3 Calculate the minimum breaking force for

35、 standard construction strands and cables by multiplying the materials tensilestrength found in Table 2 times the stand or cable area as determined by the formulas in 11.2.11.3.1 Table 2 specifies mechanical requirements for strands and cables of standard construction. The supplier and customershall

36、 determine mechanical requirements for non-standard, swaged, or drawn strands and cables.11.4 Verify that all tested strands and cable samples meet the minimum breaking force.12. Surface Finish and Handling12.1 The surface of strands and cables conforming to this specification shall be free of imper

37、fections such as tool marks, nicks,scratches, cracks, cavities, spurs, die marks, and other defects that would impair the serviceability of the wire. The surface shallbe free of embedded or deposited finishing materials and other undesirable contaminants.12.2 Finish operations such as drawing or swa

38、ging may be performed on the strands or cables as specified by the customer.12.3 The strands or cables may be subjected to a passivation process if requested by the customer. Such passivation process shallbe performed in accordance with Practice F86.12.4 The strands or cables shall be handled with c

39、are and packaged adequately to prevent damage and contamination of thesurface during transport and storage.12.5 Consider Practice F2503 to identify potential hazards produced by interactions between the device and the MRenvironment and for terms that may be used to label the device for safety in the

40、 MR environment.13. Certification13.1 The manufacturers certification that the material was manufactured and tested in accordance with this specification andthat strands and cables of standard construction meet the requirements of this specification (including a report of the test results)shall be f

41、urnished at the time of product shipment.14. Quality Program Requirements14.1 The producer shall maintain a quality program, such as that defined in ASQ C1.ISO 9001.14.2 The manufacturer of surgical implants may audit the producers quality program for conformance to the intent of ASQC1ISO 9001 or ot

42、her recognized program.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 under 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.

43、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 0.150F2180 17415. Keywords15.1 cable; cobalt alloys; metal (for surgical implants); stainless steel; strand; surgical implants; titanium/titanium alloy; wire;316LAPPENDIX(Nonmandatory Information)X1. RATION

44、ALEX1.1 The primary purpose of this specification is to characterize the materials, dimensional tolerances, construction, andmechanical properties of commonly used strands and cables for implant applications.X1.2 Tensile strength properties are included in this specification in order to characterize

45、 the relative mechanical propertiesexhibited by the various materials.X1.3 Due to the vast number of cabling configurations and possible cable and strand diameters available, this specification reliesupon the calculation of the breaking force instead of supplying an extensive tabular listing.X1.4 Th

46、e effective cross-sectional area of the strand or cable as determined in 11.2 is calculated in a manner that uses arelationship between the measured cable or strand diameter and the diameter of the individual wires. For example, as shown inFig. 1 for the 17 strand, the diameter of the strand is comp

47、osed of three individual wires. Therefore, the formula for the effectivestrand area in 11.2.2 divides the strand diameter by the number of wires across the diameter of the strand (n=3) in order todetermine the wire diameter and then by two (2) in order to determine the wire radius. The effective cro

48、ss-sectional area for thestrand is then the number of wires in 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 mentionedin this standard. Users of this standard are expressly advised that det

49、ermination 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 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