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ASTM F2180-02(2007)e2

(Specification)

Standard Specification for Metallic Implantable Strands and Cables

Standard Specification for Metallic Implantable Strands and Cables

ABSTRACT
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling constructions shall be 7×7 and 7×19 cable. Mechanical requirements include ultimate tensile strength and minimum breaking force. Strand or cable shall have no welds or splices, free of imperfections, and shall conform to dimensions, surface finish, and tolerances indicated in this specification.
SCOPE
1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables.
1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, 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.

General Information

Status
Historical
Publication Date
31-Jan-2007
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaces
ASTM F2180-02(2007)e1 - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
01-Feb-2007
Replaced By
ASTM F2180-02(2011) - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
01-Oct-2011

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ASTM F2180-02(2007)e2 - Standard Specification for Metallic Implantable Strands and CablesASTM F2180-02(2007)e2 - Standard Specification for Metallic Implantable Strands and Cables
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ASTM F2180-02(2007)e2 - Standard Specification for Metallic Implantable Strands and Cables
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´2
Designation: F2180 – 02 (Reapproved 2007)
Standard Specification for
Metallic Implantable Strands and Cables
This standard is issued under the fixed designation F2180; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—Section 3 and paragraphs 11.1 and 12.4 were editorially corrected in February 2007.
´ NOTE—Units information was editorially corrected in August 2009.
1. Scope Surgical Implant Applications (UNS R30003 and UNS
R30008)
1.1 This specification covers the materials, dimensional
F1295 Specification for Wrought Titanium-6Aluminum-
tolerances, constructions, and mechanical properties for stan-
7Niobium Alloy for Surgical Implant Applications (UNS
dard metallic implantable strands and cables.
R56700)
1.2 This specification is intended to assist in the develop-
F1314 Specification for Wrought Nitrogen Strengthened 22
ment of specific strand and cable specifications. It is particu-
Chromium−13Nickel−5Manganese−2.5Molybdenum
larly appropriate for high load bearing applications. It is not
Stainless Steel Alloy Bar and Wire for Surgical Implants
intended however, to address all of the possible variations in
(UNS S20910)
construction, material, or properties.
F1341 Specification for Unalloyed Titanium Wire UNS
1.3 The values stated in SI units are to be regarded as
R50250, UNS R50400, UNS R50550, UNS R50700, for
standard. No other units of measurement are included in this
Surgical Implant Applications
standard.
2.2 American Society for Quality (ASQ) Standard:
2. Referenced Documents ASQC1 Specification of General Requirements for a Qual-
ity Program
2.1 ASTM Standards:
2.3 Department of Defense Specifications:
E8 Test Methods for Tension Testing of Metallic Materials
MIL-DTL-83420J Wire Rope, Flexible, For Aircraft Con-
F86 Practice for Surface Preparation and Marking of Me-
trol
tallic Surgical Implants
MIL-DTL-83420/1B Wire Rope, Flexible, Type 1, Compo-
F90 Specification for Wrought Cobalt-20Chromium-
sition A
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
MIL-DTL-83420/2B Wire Rope, Flexible, Type 1, Compo-
tions (UNS R30605)
sition B
F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
3. Terminology
Implant Applications (UNS R56401)
3.1 Definitions:
F138 Specification for Wrought 18Chromium-14Nickel-
3.1.1 cable, n—agroupofstrandshelicallytwistedtogether.
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
3.1.2 diameter, n—the distance between opposing points
Implants (UNS S31673)
across the circle circumscribing either the strand or cable as
F562 Specification for Wrought 35Cobalt-35Nickel-
illustrated in Figs. 1 and 2 (see MIL-DTL-83420J, MIL-DTL-
20Chromium-10Molybdenum Alloy for Surgical Implant
83420/1B and MIL-DTL-83420/2B).
Applications (UNS R30035)
3.1.3 lay (or twist), n—the helical form taken by the wires
F1058 Specification for Wrought 40Cobalt-20Chromium-
in a strand and by the strands in a cable (see MIL-DTL-
16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for
83420J).
3.1.3.1 Discussion—Ina“RightLay”situation,thewiresof
1 the strand (or the strands in a cable) are oriented in the same
This specification is under the jurisdiction of ASTM Committee F04 on
direction as the thread on a right-hand screw.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Feb. 1, 2007. Published February 2007. Originally
approved in 2002. Last previous edition approved in 2002 as F2180–02. DOI: Withdrawn. The last approved version of this historical standard is referenced
10.1520/F2180-02R07E02. on www.astm.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from the American Society for Quality (ASQ), 600 N. Plankinton
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Ave., Milwaukee, WI 53203.
Standards volume information, refer to the standard’s Document Summary page on Available from DODSSP, Building 4, Section D, 700 Robbins Ave., Philadel-
the ASTM website. phia, PA 19111–5098.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
´2
F2180 – 02 (2007)
FIG. 1 Standard Stranding Constructions
FIG. 2 Standard Cabling Constructions
3.1.4 length of lay (or pitch), n—the distance parallel to the 5. Ordering Information
axis of the strand (or cable) in which a wire (or strand) makes
5.1 Inquiries and orders under this specification shall in-
one complete turn about the axis.
clude the following information:
3.1.5 M3N, n—theconstructiondesignationforstrandsand
5.1.1 Quantity (weight, length, or number of pieces),
cables. In this construction designation M represents the
5.1.2 ASTM designation,
number of strands in the cable and N represents the number of
5.1.3 Material (ASTM designation),
wires in each strand.
5.1.4 Condition,
3.1.5.1 Discussion— Some examples of strand construc-
5.1.5 Construction,
tions are 137 and 133. Similar examples of cable construc-
5.1.6 Applicable dimensions (including diameter, length(s)
tions are 737 and 7319.
of lay, and length),
3.1.6 strand, n—a group of wires helically twisted together.
5.1.7 Mechanical properties (including breaking force),
3.1.7 wire, n—anindividualelement(typicallyacylindrical
5.1.8 Special requirements, and
rod) making up a strand.
5.1.9 Special tests.
4. General Requirements
6. Materials and Manufacture
4.1 In addition to the requirements of this specification, all
requirements of the current editions of Specifications F90, 6.1 Wires—Implantable strands and cables shall be manu-
factured using equivalent size wires.
F136, F138, F562, F1058, F1295, F1314, and F1341 shall
apply.
6.2 Condition—Implantable strands and cables shall be
4.2 In cases of conflict between this specification and those supplied in the cold-worked, cold-worked and stress-relieved,
listed in 2.1, this specification shall take precedence. or annealed condition.
´2
F2180 – 02 (2007)
TABLE 1 Dimensional Requirements for Metallic Implantable
6.3 Finish—Types of finish available in strands and cables
Strands and Cables
are cold-drawn, pickled, swaged, or as specified by customer.
Specified Diameter, Diameter Tolerance, Out-of-Round Tolerance,
mm 6mm mm
7. Stranding
Under 0.12 0.0075 0.0075
7.1 The standard strand constructions are illustrated in Fig.
0.12 to under 0.20 0.015 0.015
1. These constructions are described in the following manner: 0.20 to under 0.30 0.022 0.022
0.30 to under 0.60 0.030 0.030
7.1.1 133 Strand—This construction is characterized by a
0.60 to under 0.82 0.037 0.037
left-hand lay with a uniform pitch of 4 to 10 times the nominal
0.82 to under 1.10 0.060 0.060
strand diameter. 1.10 to under 2.50 0.075 0.075
2.50 to under 4.10 0.150 0.150
7.1.2 137 Strand—This construction is characterized by a
left-hand lay with a uniform pitch of 8 to 16 times the nominal
strand diameter.
11.2 Use the following formulas for determining the effec-
7.1.3 1319 Strand—This construction is characterized by
tive cross-sectional area for standard construction strands or
a
...

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SCOPE
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.  
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.  
1.3 This test method may require modifications to accommodate other tibial tray designs.  
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    6 pages
    English language
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  • Standard
    6 pages
    English language
    sale 15% off