ASTM F2819-10(2015)e1
(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
5.1 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.
5.1.1 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.
5.2 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. They also apply 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 measu...
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´1
Designation:F2819 −10 (Reapproved 2015)
Standard Test Methods for
Measurement of Straightness of Bar, Rod, Tubing and Wire
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.
ε NOTE—Editorial corrections were made in June 2016.
1. Scope a maximum dimension between 6.35 and 101.6 mm (0.25 and
4 in). For measurement of flatness (camber), refer to Test
1.1 This standard covers the various test methods to be used
Method F2754/F2754M.
for measurement of straightness of bar, rod, tubing, and wire.
Thesetestmethodsapplyprimarilytobar,rod,tubing,andwire
NOTE 3—The current version of Test Method F2754/F2754M covers a
that are ordered in the straightened and cut-to-length condition.
different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and
They also apply to small diameter tubing and wire that has does not include superelastic NiTi. These exceptions would not affect the
camber measurement as conducted by Test Method F2754/F2754M.
been specially processed to roll off a spool in the straightened
condition.
1.6 These test methods apply to ferrous and non-ferrous
alloys including linear-elastic or superelastic nitinol. Refer to
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 Terminology F2005 for more details on NiTi terminology.
0.188 in.). They also apply to flatness (camber) of flat-shaped
1.7 The values stated in either SI units or inch-pound units
wire or ribbon with a maximum dimension between 0.05 and
are to be regarded separately as standard. The values stated in
4.78 mm (0.002 and 0.188 in.). For flatness (camber)
each system may not be exact equivalents; therefore, each
measurement, refer to Test Method F2754/F2754M.
system shall be used independently of the other. Combining
NOTE 1—The current version of Test Method F2754/F2754M covers a
values from the two systems may result in non-conformance
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 with the standard.
camber measurement as conducted by Test Method F2754/F2754M.
1.8 This standard does not purport to address all of the
1.3 These test methods apply to straightness of round tubing
safety concerns, if any, associated with its use. It is the
that has an outer diameter between 0.05 and 6.35 mm (0.002
responsibility of the user of this standard to establish appro-
and 0.25 in.).
priate safety and health practices and determine the applica-
1.4 These test methods apply to straightness of round rod
bility of regulatory limitations prior to use.
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
2. Referenced Documents
with a maximum dimension between 4.78 and 6.35 mm (0.188
2.1 ASTM Standards:
and 0.25 in). For measurement of flatness (camber), refer to
F2005 Terminology for Nickel-Titanium Shape Memory
Test Method F2754/F2754M.
Alloys
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
F2754/F2754M Test Method for Measurement of Camber,
does not include superelastic NiTi. These exceptions would not affect the
Cast, Helix and Direction of Helix of Coiled Wire
camber measurement as conducted by Test Method F2754/F2754M.
2.2 Other Standards:
1.5 These test methods apply to straightness of round bar
GGG-P-463 U.S. Federal Specification: Plate, Surface
thathasadiameterbetween6.35and101.6mm(0.25and4in).
(Granite)
It also applies to flatness (camber) of flat and shaped bar with
1 2
These test methods are under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
CurrenteditionapprovedMay1,2015.PublishedJuly2015.Originallyapproved the ASTM website.
in 2010. Last previous edition approved in 2010 as F2819 – 10. DOI: 10.1520/ Available from IHS, 321 Inverness Drive South Englewood, CO 80112,
F2819–10R15E01. http://www.global.ihs.com.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F2819−10 (2015)
3. Terminology (0.188 and 0.25 in.), tubing with diameter 0.05 to 6.35 mm
(0.0002 to 0.25 in.) or bar with a diameter between 6.35 to
3.1 Fig. 1 and Fig. 2 show the physical meaning of
101.7 mm (0.25 to 4 in.), the gap test can be used to measure
straightness. Fig. 3 shows the definition of wobble in a straight
straightness. The gap test can also be used for flat or shaped
wire or tube as it is being rotated.
wire and ribbon. In this method, a thickness gauge equal to the
3.2 Definitions of Terms Specific to This Standard:
gap must not fit between the rod, tubing, or bar and flat surface
3.2.1 straightness—Deviation of an axis or surface element
at any point along its length when rolled or rotated 360°. The
from linearity over a unit length in the unloaded (force and
gap defines the straightness of the rod, tubing, or bar.
momentfree)condition.Aperfectlystraightconditionisshown
4.5 Total Indicator Readout (TIR) test (quantitative test
in Fig. 1. A non-straight condition is shown in Fig. 2.
method)—In this method, a round rod with a diameter between
3.2.2 wobble—Elliptical rotation observed in a small diam-
4.78 and 6.35 mm (0.188 and 0.25 in.) or round bar with a
eter wire or tube as it is being rotated around a central axis as
diameterbetween6.35to101.7mm(0.25to4in.),isplacedon
is shown in Fig. 3.
two or more V-blocks. The test specimen is then rotated one
revolution between two or more V-blocks that are a fixed
4. Summary of Test Method
distance (d) apart while measuring in the center with an
4.1 For bar, rod, tube, and wire, the deviation from the
indicator. Total Indicator Readout (TIR) in the test specimen is
condition of resting flat on a smooth surface can be measured
then calculated.
by using a quantitative or qualitative test method. Two quan-
titative and two qualitative methods are the gap and TIR (Total
5. Significance and Use
Indicator Readout) and inclined flat plate and finger roll tests,
5.1 Significance—With the birth of minimally invasive sur-
respectively
geryinthe1960s,therehasbeenarequirementforguidewires.
4.2 Inclined Flat Plate Test (qualitative test method that can
The guide wires serve as the access line by which procedures
be made quantitative)—Acommonmethodformeasurementof
like balloon angioplasty and stent placement are conducted. A
straightness of wire or tubing with a diameter less than 4.78
guide wire typically consists of a mandrel, coil and in some
mm (0.188 in.) is the inclined flat plate test. In this method, a
cases a safety wire is used. The market for guide wires
sectioned piece of material is allowed to roll down an inclined
continues to grow as the number of procedures increases. For
table as is illustrated by Fig. 4 and Fig. 5. The material passes
successful manufacturing of guide wires, linearity or straight-
the test if it rolls freely down the table without stopping as is
ness of 304 stainless steel and nitinol wire that is used for the
shown by Fig. 5.
manufacture of guide wire mandrels is critical to their end use
4.3 Finger-Roll Test (qualitative test method)—A second
performance. Users of guide wires require that they must
common method for measurement of straightness that is used
navigate a tortuous anatomy.
for wire and tubing with a diameter less than 0.25 mm (0.010
5.1.1 Asecond part of minimally invasive surgery is the use
in.) is the finger-roll test. In this test, a cut length of wire or
of machined or formed wire, tube, or rod. In this case,
tubing is laid on a flat surface. A finger, pencil, pen, or plastic
straightness of rod, tube, and wire that is going to be machined
card is used to rotate the center of the sample back and forth on
or subjected to a forming practice such as bending needs to be
the flat surface. The opposite ends of the sample should rotate
very linear or straight so it is accurately fed into the equipment
smoothly without wobble as is defined in 3.2.2 of these test
that is used for the machining or forming practice. Laser
methods.
machiningisanexampleofamachiningoperationthatrequires
4.4 Gap Test (quantitative test method)—A common quan- a wobble-free piece of rod, tubing, or wire so that it can be
titative method for measurement of straightness of wire with a properly fed into the alignment bushings of the laser. Wire
diameter less than 4.78 mm (0.188 in.) is the gap test. It can forming equipment also requires wobble-free material for the
alsobeusedforrodwithadiameterbetween4.78and6.35mm same reason.
FIG. 1Definition of a “Straight” Condition
´1
F2819−10 (2015)
FIG. 2Definition of a “Non-straight” Condition
FIG. 3Definition of Wobble in a Small Diameter Tube or Wire as it is Being Rotated
FIG. 4Example of a Table and Granite Parallel Used to Measure Straightness by the Roll Test
FIG. 5Example of Inclined Surface Table and Protractor Used to Measure Straightness by the Roll Test Method
5.2 Use—These test methods can be used by users and 6. Apparatus
producersofmedicalgradebar,rod,tubing,andwiretospecify
6.1 For the inclined flat plate test, a flat table preferably
requirements to evaluate and confirm the straightness of
made of granite that can be precisely inclined is required. The
material. Depending upon the type of material and its metal-
flat table should have an inspection grade; grade A, flatness as
lurgical condition, it may be possible to reprocess the material
set forth by Federal Specification GGG-P-463. A precise
to reduce its non-linearity.
´1
F2819−10 (2015)
measurement device and a protractor are also required. Ex- the sample should be preheated to a temperature greater than
amples of precise measurement devices that can be used are the a
...
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.
´1
Designation: F2819 − 10 (Reapproved 2015) F2819 − 10 (Reapproved 2015)
Standard Test Methods for
Measurement of Straightness of Bar, Rod, Tubing and Wire
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.
ε NOTE—Editorial corrections were made in June 2016.
1. 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. ItThey
also appliesapply 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 by Test Method F2754/F2754M.
1.6 These test methods apply to ferrous and non-ferrous alloys including linear-elastic or superelastic nitinol. Refer to
Terminology F2005 for more details on NiTi terminology.
1.7 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
1.8 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2.1 ASTM Standards:
F2005 Terminology for Nickel-Titanium Shape Memory Alloys
These test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved May 1, 2015. Published July 2015. Originally approved in 2010. Last previous edition approved in 2010 as F2819 – 10. DOI:
10.1520/F2819–10R15.10.1520/F2819–10R15E01.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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 the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F2819 − 10 (2015)
F2754/F2754M Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
2.2 Other Standards:
GGG-P-463 U.S. Federal Specification: Plate, Surface (Granite)
3. Terminology
3.1 Fig. 1 and Fig. 2 show the physical meaning of straightness. Fig. 3 shows the definition of wobble in a straight wire or tube
as it is being rotated.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 straightness—Deviation of an axis or surface element from linearity over a unit length in the unloaded (force and moment
free) condition. A perfectly straight condition is shown in Fig. 1. An unloadedA non-straight condition is shown in Fig. 2.
3.2.2 wobble—Elliptical rotation observed in a small diameter wire or tube as it is being rotated around a central axis as is shown
in Fig. 3.
4. Summary of Test Method
4.1 For bar, rod, tube, and wire, the deviation from the condition of resting flat on a smooth surface can be measured by using
a quantitative or qualitative test method. Two quantitative and two qualitative methods are the gap and TIR (Total Indicator
Readout) and inclined flat plate and finger roll tests, respectively
4.2 Inclined Flat Plate Test (qualitative test method that can be made quantitative)—A common method for measurement of
straightness of wire or tubing with a diameter less than 4.78 mm (0.188 in.) is the inclined flat plate test. In this method, a sectioned
piece of material is allowed to roll down an inclined table as is illustrated by Fig. 4 and Fig. 5. The material passes the test if it
rolls freely down the table l without stopping as is shown by Fig. 5.
4.3 Finger-Roll Test (qualitative test method)—A second common method for measurement of straightness that is used for wire
and tubing with a diameter less than 0.25 mm (0.010 in.) is the finger-roll test. In this test, a cut length of wire or tubing is laid
on a flat surface. A finger, pencil, pen, or plastic card is used to rotate the center of the sample back and forth on the flat surface.
The opposite ends of the sample should rotate smoothly without wobble as is defined in 3.2.2 of these test methods.
4.4 Gap Test (quantitative test method)—A common quantitative method for measurement of straightness of wire with a
diameter less than 4.78 mm (0.188 in.) is the gap test. It can also be used for rod with a diameter between 4.78 and 6.35 mm (0.188
and 0.25 in.), tubing with diameter 0.05 to 6.35 mm (0.0002 to 0.25 in.) or bar with a diameter between 6.35 to 101.7 mm (0.25
to 4 in.), the gap test can be used to measure straightness. The gap test can also be used for flat or shaped wire and ribbon. In this
method, a thickness gauge equal to the gap must not fit between the rod, tubing, or bar and flat surface at any point along its length
when rolled or rotated 360°. The gap defines the straightness of the rod, tubing, or bar.
4.5 Total Indicator Readout (TIR) test (quantitative test method)—In this method, a round rod with a diameter between 4.78 and
6.35 mm (0.188 and 0.25 in.) or round bar with a diameter between 6.35 to 101.7 mm (0.25 to 4 in.), is placed on two or more
V-blocks. The test specimen is then rotated one revolution between two or more V-blocks that are a fixed distance (d) apart while
measuring in the center with an indicator. Total Indicator Readout (TIR) in the test specimen is then calculated.
Available from IHS, 321 Inverness Drive South Englewood, CO 80112, http://www.global.ihs.com.
FIG. 1 Definition of a “Straight” Condition
´1
F2819 − 10 (2015)
FIG. 2 Definition of a “Nonstraight”“Non-straight” Condition
FIG. 3 Definition of Wobble in a Small Diameter Tube or Wire as it is Being Rotated
FIG. 4 Example of a Table and Granite Parallel Used to Measure Straightness by the Roll Test
FIG. 5 Example of Inclined Surface Table and Protractor Used to Measure Straightness by the Roll Test Method
5. Significance and Use
5.1 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.
5.1.1 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
´1
F2819 − 10 (2015)
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.
5.2 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.
6. Apparatus
6.1 For the inclined flat plate test, a flat table preferably made of granite that can be precisely inclined is required. The flat table
should have an inspection grade; grade A, flatness as set forth by Federal Specification GGG-P-463. A precise measurement device
...
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