ASTM F366-10
(Specification)Standard Specification for Fixation Pins and Wires
Standard Specification for Fixation Pins and Wires
ABSTRACT
This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.
SCOPE
1.1 This specification covers functional dimensions for fixation pins and wires.
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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Designation:F366 −10
StandardSpecification for
1
Fixation Pins and Wires
ThisstandardisissuedunderthefixeddesignationF366;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F562 Specification for Wrought 35Cobalt-35Nickel-
20Chromium-10Molybdenum Alloy for Surgical Implant
1.1 This specification covers functional dimensions for
Applications (UNS R30035)
fixation pins and wires.
F563 Specification for Wrought Cobalt-20Nickel-
1.2 In recognition of many broad and varied uses of such
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
pins and wires, many options are included. A variety, but not
for Surgical Implant Applications (UNS R30563) (With-
necessarily all, of the options are illustrated in Figs. 1-3. 3
drawn 2005)
F1314 Specification for Wrought Nitrogen Strengthened 22
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
Stainless Steel Alloy Bar and Wire for Surgical Implants
standard.
(UNS S20910)
F1537 Specification for Wrought Cobalt-28Chromium-
2. Referenced Documents
2 6Molybdenum Alloys for Surgical Implants (UNS
2.1 ASTM Standards:
R31537, UNS R31538, and UNS R31539)
F67 Specification for Unalloyed Titanium, for Surgical Im-
F1586 Specification for Wrought Nitrogen Strengthened
plant Applications (UNS R50250, UNS R50400, UNS
21Chromium—10Nickel—3Manganese—
R50550, UNS R50700)
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Implants (UNS S31675)
Alloy Castings and Casting Alloy for Surgical Implants
(UNS R30075)
3. Materials
F86 Practice for Surface Preparation and Marking of Metal-
3.1 Fixationpinsandwiresshallbefabricatedfrommaterial
lic Surgical Implants
conforming to one of the followingASTM Specifications: F67,
F90 Specification for Wrought Cobalt-20Chromium-
F75, F90, F136, F138, F562, F563, F1314, F1537, and F1586.
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
tions (UNS R30605)
4. Performance Requirements
F136 Specification for Wrought Titanium-6Aluminum-
4.1 Factors considered to be important, but for which values
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
and test methods have not been established, are bending
Implant Applications (UNS R56401)
strength, fatigue strength, breaking strength (Knowles Type
F138 Specification for Wrought 18Chromium-14Nickel-
only), torsion strength, and ductility.
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
Implants (UNS S31673)
5. Dimensions and Characteristics
F368 Specification for Fixation Pins-Knowles and Hagie
3
Types (Withdrawn 1982)
5.1 Fixationpinsandwiresshallbefabricatedinaccordance
with the dimensions illustrated in Figs. 1-4.
5.2 Fixation pins and wires shall have surfaces prepared and
1
This specification is under the jurisdiction of ASTM Committee F04 on
marked in accordance with Practice F86.
Medical and Surgical Materials and Devices and is the direct responsibility of
5.2.1 Optional marking on the fixation pins and wires shall
Subcommittee F04.21 on Osteosynthesis.
identify the manufacturer or distributor.
CurrenteditionapprovedJune1,2010.PublishedJuly2010.Originallyapproved
in 1973. Last previous edition approved in 2009 as F366 – 04 (2009). DOI:
10.1520/F0366-10. 6. Packaging and Labeling
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
6.1 Packaging shall be adequate to protect the fixation pins
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on and wires during shipment.
the ASTM website.
3
6.2 Labeling for fixation pins and wires shall include:
The last approved version of this historical standard is referenced on
www.astm.org. 6.2.1 Product name,
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F366−10
NOTE 1—Pins and wires may be smooth shank or threaded.
NOTE 2—Point angle and helix angle, where applicable, is as specified by manufacturer.
NOTE 3—On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger
than 3.2 mm may be reduced.
NOTE 4—Optional designs, both ends pointed or point with suture hole.
FIG. 1Fixation Pins and Wires
6.2.2 Size, on the immediate container, 7. Keywords
6.2.2.1 Length,
7.1 fixation materials; flexible surgical wire; orthopaedic
6.2.2.2 Diameter (if round) or cross-sectional size (if square
medica
...
This 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. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F366–04 (Reapproved 2009) Designation: F366 – 10
Standard Specification for
1
Fixation Pins and Wires
ThisstandardisissuedunderthefixeddesignationF366;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope
1.1 This specification covers functional dimensions for fixation pins and wires.
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not
necessarily all, of the options are illustrated in Figs. 1-3.
1.3The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
2
2.1 ASTM Standards:
F67 Specification for UnalloyedTitanium, for Surgical ImplantApplications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
3
F368 Specification for Fixation Pins-Knowles and Hagie Types
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5IronAlloy for Surgical Implant
Applications (UNS R30563)
F1314 SpecificationforWroughtNitrogenStrengthened22Chromium13Nickel5Manganese2.5MolybdenumStainlessSteel
Alloy Bar and Wire for Surgical Implants (UNS S20910)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F1586 Specification for Wrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel
Alloy Bar for Surgical Implants (UNS S31675)
3. Materials
3.1 Fixation pins and wires shall be fabricated from material conforming to one of the following ASTM Specifications: F67,
F75, F90, F136, F138, F562, F563, F1314, F1537, and F1586.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.21 on Osteosynthesis.
Current edition approved April 1, 2009. Published April 2009. Originally approved in 1973. Last previous edition approved in 2004 as F366–04. DOI:
10.1520/F0366-04R09.
Current edition approved June 1, 2010. Published July 2010. Originally approved in 1973. Last previous edition approved in 2009 as F366 – 04 (2009). DOI:
10.1520/F0366-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F366 – 10
NOTE 1—Pins and wires may be smooth shank or threaded.
NOTE 2—Point angle and helix angle, where applicable, is as specified by manufacturer.
NOTE 3—On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger
than 3.2 mm may be reduced.
NOTE 4—Optional designs, both ends pointed or point with suture hole.
FIG. 1 Fixation Pins and Wires
4. Performance Requirements
4.1 Factors considered to be important, but for which values and test methods have not been established, are bending strength,
fatigue strength, breaking strength (Knowles Type only), torsion strength, and ductility.
5. Dimensions and Characteristics
5.1 Fixation pins an
...
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