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ASTM F2180-02(2011)

(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
30-Sep-2011
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)e2 - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
01-Oct-2011
Replaced By
ASTM F2180-02(2011)e1 - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
01-Oct-2011

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ASTM F2180-02(2011) - Standard Specification for Metallic Implantable Strands and CablesASTM F2180-02(2011) - Standard Specification for Metallic Implantable Strands and Cables
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ASTM F2180-02(2011) - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
Designation: F2180 – 02 (Reapproved 2011)
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.
1. Scope F1295 Specification for Wrought Titanium-6Aluminum-
7Niobium Alloy for Surgical Implant Applications (UNS
1.1 This specification covers the materials, dimensional
R56700)
tolerances, constructions, and mechanical properties for stan-
F1314 Specification for Wrought Nitrogen Strengthened 22
dard metallic implantable strands and cables.
Chromium−13Nickel−5Manganese−2.5Molybdenum
1.2 This specification is intended to assist in the develop-
Stainless Steel Alloy Bar and Wire for Surgical Implants
ment of specific strand and cable specifications. It is particu-
(UNS S20910)
larly appropriate for high load bearing applications. It is not
F1341 Specification for Unalloyed Titanium Wire UNS
intended however, to address all of the possible variations in
R50250, UNS R50400, UNS R50550, UNS R50700, for
construction, material, or properties.
Surgical Implant Applications
1.3 The values stated in SI units are to be regarded as
2.2 American Society for Quality (ASQ) Standard:
standard. No other units of measurement are included in this
ASQC1 Specification of General Requirements for a Qual-
standard.
ity Program
2. Referenced Documents 2.3 Department of Defense Specifications:
MIL-DTL-83420J Wire Rope, Flexible, For Aircraft Con-
2.1 ASTM Standards:
trol
E8 Test Methods for Tension Testing of Metallic Materials
MIL-DTL-83420/1B Wire Rope, Flexible, Type 1, Compo-
F86 Practice for Surface Preparation and Marking of Me-
sition A
tallic Surgical Implants
MIL-DTL-83420/2B Wire Rope, Flexible, Type 1, Compo-
F90 Specification for Wrought Cobalt-20Chromium-
sition B
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
tions (UNS R30605)
3. Terminology
F136 Specification for Wrought Titanium-6Aluminum-
3.1 Definitions:
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
3.1.1 cable, n—agroupofstrandshelicallytwistedtogether.
Implant Applications (UNS R56401)
3.1.2 diameter, n—the distance between opposing points
F138 Specification for Wrought 18Chromium-14Nickel-
across the circle circumscribing either the strand or cable as
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
illustrated in Figs. 1 and 2 (see MIL-DTL-83420J, MIL-DTL-
Implants (UNS S31673)
83420/1B and MIL-DTL-83420/2B).
F562 Specification for Wrought 35Cobalt-35Nickel-
3.1.3 lay (or twist), n—the helical form taken by the wires
20Chromium-10Molybdenum Alloy for Surgical Implant
in a strand and by the strands in a cable (see MIL-DTL-
Applications (UNS R30035)
83420J).
F1058 Specification for Wrought 40Cobalt-20Chromium-
3.1.3.1 Discussion—Ina“RightLay”situation,thewiresof
16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for
the strand (or the strands in a cable) are oriented in the same
Surgical Implant Applications (UNS R30003 and UNS
direction as the thread on a right-hand screw.
R30008)
3.1.4 length of lay (or pitch), n—the distance parallel to the
axis of the strand (or cable) in which a wire (or strand) makes
This specification is under the jurisdiction of ASTM Committee F04 on
one complete turn about the axis.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Oct. 1, 2011. Published October 2011. Originally
´2 3
approved in 2002. Last previous edition approved in 2007 as F2180–02 (2007) . Withdrawn. The last approved version of this historical standard is referenced
DOI: 10.1520/F2180-02R11. on www.astm.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
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.
F2180 – 02 (2011)
FIG. 1 Standard Stranding Constructions
FIG. 2 Standard Cabling Constructions
3.1.5 M3N, n—theconstructiondesignationforstrandsand 5. Ordering Information
cables. In this construction designation M represents the
5.1 Inquiries and orders under this specification shall in-
number of strands in the cable and N represents the number of
clude the following information:
wires in each strand.
5.1.1 Quantity (weight, length, or number of pieces),
3.1.5.1 Discussion— Some examples of strand construc-
5.1.2 ASTM designation,
tions are 137 and 133. Similar examples of cable construc-
5.1.3 Material (ASTM designation),
tions are 737 and 7319.
5.1.4 Condition,
3.1.6 strand, n—a group of wires helically twisted together.
5.1.5 Construction,
3.1.7 wire, n—anindividualelement(typicallyacylindrical
5.1.6 Applicable dimensions (including diameter, length(s)
rod) making up a strand.
of lay, and length),
5.1.7 Mechanical properties (including breaking force),
4. General Requirements
5.1.8 Special requirements, and
4.1 In addition to the requirements of this specification, all
5.1.9 Special tests.
requirements of the current editions of Specifications F90,
F136, F138, F562, F1058, F1295, F1314, and F1341 shall
6. Materials and Manufacture
apply.
4.2 In cases of conflict between this specification and those 6.1 Wires—Implantable strands and cables shall be manu-
listed in 2.1, this specification shall take precedence. factured using equivalent size wires.
F2180 – 02 (2011)
TABLE 1 Dimensional Requirements for Metallic Implantable
6.2 Condition—Implantable strands and cables shall be
Strands and Cables
supplied in the cold-worked, cold-worked and stress-relieved,
Specified Diameter, Diameter Tolerance, Out-of-Round Tolerance,
or annealed condition.
mm 6mm mm
6.3 Finish—Types of finish available in strands and cables
Under 0.12 0.0075 0.0075
are cold-drawn, pickled, swaged, or as specified by customer.
0.12 to under 0.20 0.015 0.015
0.20 to under 0.30 0.022 0.022
0.30 to under 0.60 0.030 0.030
7. Stranding
0.60 to under 0.82 0.037 0.037
0.82 to under 1.10 0.060 0.060
7.1 The standard strand constructions are illustrated in Fig.
1.10 to under 2.50 0.075 0.075
1. These constructions are described in the following manner:
2.50 to under 4.10 0.150 0.150
7.1.1 133 Strand—This construction is characterized by a
left-hand lay with a uniform pitch of 4 to 10 times the nominal
strand diameter.
11. Mechanical Requirements
7.1.2 137 Strand—This construction is characterized by a
11.1 TeststrandsandcablesshallbeinaccordancewithTest
left-hand lay with a uniform pitch of 8 to 16 times the nominal
Method E8. When tensile testing strands and cables, use a
strand diameter.
gauge length of 254 mm.
7.1.3 1319 Strand—This construction is characterized by
11.2 Use the following formulas for determining the effec-
an inner 137 strand with a rig
...

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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