ASTM F2819-10
(Test Method)Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
SIGNIFICANCE AND USE
Significance—With the birth of minimally invasive surgery in the 1960s, there has been a requirement for guide wires. The guide wires serve as the access line by which procedures like balloon angioplasty and stent placement are conducted. A guide wire typically consists of a mandrel, coil and in some cases a safety wire is used. The market for guide wires continues to grow as the number of procedures increases. For successful manufacturing of guide wires, linearity or straightness of 304 stainless steel and nitinol wire that is used for the manufacture of guide wire mandrels is critical to their end use performance. Users of guide wires require that they must navigate a tortuous anatomy.
A second part of minimally invasive surgery is the use of machined or formed wire, tube, or rod. In this case, straightness of rod, tube, and wire that is going to be machined or subjected to a forming practice such as bending needs to be very linear or straight so it is accurately fed into the equipment that is used for the machining or forming practice. Laser machining is an example of a machining operation that requires a wobble-free piece of rod, tubing, or wire so that it can be properly fed into the alignment bushings of the laser. Wire forming equipment also requires wobble-free material for the same reason.
Use—These test methods can be used by users and producers of medical grade bar, rod, tubing, and wire to specify requirements to evaluate and confirm the straightness of material. Depending upon the type of material and its metallurgical condition, it may be possible to reprocess the material to reduce its non-linearity.
SCOPE
1.1 This standard covers the various test methods to be used for measurement of straightness of bar, rod, tubing, and wire. These test methods apply primarily to bar, rod, tubing, and wire that are ordered in the straightened and cut-to-length condition. It also applies to small diameter tubing and wire that has been specially processed to roll off a spool in the straightened condition.
1.2 These test methods apply to straightness of round wire that has a diameter between 0.05 and 4.78 mm (0.002 and 0.188 in.). They also apply to flatness (camber) of flat-shaped wire or ribbon with a maximum dimension between 0.05 and 4.78 mm (0.002 and 0.188 in.). For flatness (camber) measurement, refer to Test Method F2754/F2754M.
Note 1—The current version of Test Method F2754/F2754M covers a different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and does not include superelastic NiTi. These exceptions would not affect the camber measurement as conducted by Test Method F2754/F2754M.
1.3 These test methods apply to straightness of round tubing that has an outer diameter between 0.05 and 6.35 mm (0.002 and 0.25 in.).
1.4 These test methods apply to straightness of round rod that has a diameter between 4.78 and 6.35 mm (0.188 and 0.25 in). It also applies to flatness (camber) of flat and shaped rod with a maximum dimension between 4.78 and 6.35 mm (0.188 and 0.25 in). For measurement of flatness (camber), refer to Test Method F2754/F2754M.
Note 2—The current version of Test Method F2754/F2754M covers a different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and does not include superelastic NiTi. These exceptions would not affect the camber measurement as conducted by Test Method F2754/F2754M.
1.5 These test methods apply to straightness of round bar that has a diameter between 6.35 and 101.6 mm (0.25 and 4 in). It also applies to flatness (camber) of flat and shaped bar with a maximum dimension between 6.35 and 101.6 mm (0.25 and 4 in). For measurement of flatness (camber), refer to Test Method F2754/F2754M.
Note 3—The current version of Test Method F2754/F2754M covers a different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and does not include superelastic NiTi. These exceptions would not affect the camber measurement as conducted ...
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Designation:F2819 −10
StandardTest Methods for
Measurement of Straightness of Bar, Rod, Tubing and Wire
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to be used for Medical Devices
This standard is issued under the fixed designation F2819; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
NOTE 3—The current version of Test Method F2754/F2754M covers a
1. Scope
different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and
1.1 This standard covers the various test methods to be used
does not include superelastic NiTi. These exceptions would not affect the
for measurement of straightness of bar, rod, tubing, and wire. camber measurement as conducted by Test Method F2754/F2754M.
Thesetestmethodsapplyprimarilytobar,rod,tubing,andwire
1.6 These test methods apply to ferrous and non-ferrous
that are ordered in the straightened and cut-to-length condition.
alloys including linear-elastic or superelastic nitinol. Refer to
It also applies to small diameter tubing and wire that has been
Terminology F2005 for more details on NiTi terminology.
specially processed to roll off a spool in the straightened
1.7 The values stated in either SI units or inch-pound units
condition.
are to be regarded separately as standard. The values stated in
1.2 These test methods apply to straightness of round wire
each system may not be exact equivalents; therefore, each
that has a diameter between 0.05 and 4.78 mm (0.002 and
system shall be used independently of the other. Combining
0.188 in.). They also apply to flatness (camber) of flat-shaped
values from the two systems may result in non-conformance
wire or ribbon with a maximum dimension between 0.05 and
with the standard.
4.78 mm (0.002 and 0.188 in.). For flatness (camber)
1.8 This standard does not purport to address all of the
measurement, refer to Test Method F2754/F2754M.
safety concerns, if any, associated with its use. It is the
NOTE 1—The current version of Test Method F2754/F2754M covers a
responsibility of the user of this standard to establish appro-
different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and
does not include superelastic NiTi. These exceptions would not affect the
priate safety and health practices and determine the applica-
camber measurement as conducted by Test Method F2754/F2754M.
bility of regulatory limitations prior to use.
1.3 These test methods apply to straightness of round tubing
that has an outer diameter between 0.05 and 6.35 mm (0.002 2. Referenced Documents
and 0.25 in.). 2
2.1 ASTM Standards:
1.4 These test methods apply to straightness of round rod F2005 Terminology for Nickel-Titanium Shape Memory
that has a diameter between 4.78 and 6.35 mm (0.188 and 0.25
Alloys
in). It also applies to flatness (camber) of flat and shaped rod F2754/F2754M Test Method for Measurement of Camber,
with a maximum dimension between 4.78 and 6.35 mm (0.188 Cast, Helix and Direction of Helix of Coiled Wire
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and 0.25 in). For measurement of flatness (camber), refer to
2.2 Other Standards:
Test Method F2754/F2754M.
GGG-P-463 U.S. Federal Specification: Plate, Surface
NOTE 2—The current version of Test Method F2754/F2754M covers a
(Granite)
different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and
does not include superelastic NiTi. These exceptions would not affect the
3. Terminology
camber measurement as conducted by Test Method F2754/F2754M.
1.5 These test methods apply to straightness of round bar 3.1 Fig. 1 and Fig. 2 show the physical meaning of
thathasadiameterbetween6.35and101.6mm(0.25and4in). straightness. Fig. 3 shows the definition of wobble in a straight
It also applies to flatness (camber) of flat and shaped bar with wire as it is being rotated.
a maximum dimension between 6.35 and 101.6 mm (0.25 and
3.2 Definitions of Terms Specific to This Standard:
4 in). For measurement of flatness (camber), refer to Test
Method F2754/F2754M.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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These test methods are under the jurisdiction of ASTM Committee F04 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Medical and Surgical Materials and Devices and is the direct responsibility of Standards volume information, refer to the standard’s Document Summary page on
Subcommittee F04.15 on Material Test Methods. the ASTM website.
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Current edition approved Dec. 15, 2010. Published January 2011 DOI: 10.1520/ Available from IHS, 321 Inverness Drive South Englewood, CO 80112,
F2819–10. http://www.global.ihs.com.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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