ASTM F2633-07

Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

ABSTRACT
This specification covers the chemical, mechanical, and dimensional requirements for wrought seamless nickel-titanium shape memory alloy tubes used for the manufacture of medical devices and surgical implants. Tubes shall be furnished in the superelastic condition, and the outer surface shall have a pickled, ground, or mechanically polished finish, or as agreed upon between purchaser and supplier. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms. This specification applies precisely to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness. The mechanical properties to which the tubes shall conform are ultimate tensile strength (UTS), uniform elongation, upper plateau strength, lower plateau strength, and residual elongation.
SCOPE
1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 % to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F 2063. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F 2063.
1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness.
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses (inch-pound units) are for information only.

General Information

• Status: Historical
• Publication Date: 31-Mar-2007
• ICS: 77.150.40 - Nickel and chromium products
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaced By: ASTM F2633-13 - Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
• Effective Date: 01-Oct-2013
• Referred By: ASTM F2063-18 - Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
• Effective Date: 01-Apr-2007

Standards Content (Sample)

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:F2633 −07
StandardSpecification for
Wrought Seamless Nickel-Titanium Shape Memory Alloy
Tube for Medical Devices and Surgical Implants
This standard is issued under the fixed designation F2633; 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.
1. Scope F2516 Test Method for Tension Testing of Nickel-Titanium
Superelastic Materials
1.1 This specification covers the requirements for wrought
2.2 ISO Standard:
nickel-titanium shape memory alloy tube, nominally 54.5 % to
ISO 9001 Quality Management Systems—Requirements
57.0 mass/mass (weight) % nickel, in the superelastic
condition, used for the manufacture of medical devices and
2.3 American Society for Quality Standards:
surgical implants. Material shall conform to the applicable
ASQ C1 Specification of General Requirements for a Qual-
requirements of Specification F2063. This specification ad-
ity Program
dressesthoseproductvariablesthatdifferentiatedrawnmedical
grade tube from the raw material and mill product forms 3. Terminology
covered in Specification F2063.
3.1 Definitions of Terms Specific to This Standard:
1.2 This specification applies to tube with 10 mm (0.4 in.) 3.2 See Terminology F2005 for the definition of terms used
and smaller nominal outside diameter and 2 mm (0.08 in.) and in this specification that are specific to nickel-titanium alloys.
thinner nominal wall thickness.
3.3 individual wall thickness measurement, n—any one of
the wall thickness measurements taken around the circumfer-
1.3 The values stated in SI units are to be regarded as the
ence on any one transverse cross-section of a single sample of
standard. The values given in parentheses (inch-pound units)
the tube.
are for information only.
3.4 lot, n—thetotalquantityoftubeproducedfromthesame
2. Referenced Documents
melt heat under the same conditions, at essentially the same
time.
2.1 ASTM Standards:
3.4.1 Discussion—For purposes of this specification, con-
A632 Specification for Seamless and Welded Austenitic
version from bar to tubular form by extrusion, gundrilling, or
Stainless Steel Tubing (Small-Diameter) for General Ser-
other method is included within the scope of this definition.
vice
F2004 Test Method for Transformation Temperature of
3.5 lot average concentricity, n—the arithmetic average of
Nickel-Titanium Alloys by Thermal Analysis
the sample concentricities measured on a statistically represen-
F2005 Terminology for Nickel-Titanium Shape Memory
tative number of samples from the lot.
Alloys
3.6 lot average wall thickness, n—the grand average of the
F2063 Specification for Wrought Nickel-Titanium Shape
sample average wall thicknesses measured on a statistically
Memory Alloys for Medical Devices and Surgical Im-
representative number of samples from the lot.
plants
3.7 nominal outside diameter (OD), n— the outside diam-
F2082 Test Method for Determination of Transformation
eter specified by the purchaser without regard to tolerance.
Temperature of Nickel-Titanium Shape Memory Alloys
3.8 nominal wall thickness, n—the wall thickness specified
by Bend and Free Recovery
by the purchaser without regard to tolerance.
3.9 sample average wall thickness, n— the arithmetic aver-
age of all individual wall thickness measurements measured on
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
a single sample.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved April 1, 2007. Published May 2007. DOI: 10.1520/
F2633-07.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203, http://www.asq.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2633−07
TABLE 2 Permissible Variation in OD or ID Dimensions
3.10 sample concentricity, n—two times the offset between
the centers of the two circles representing the outside diameter Nominal OD or ID in mm (in.) Permissible Variation
from Nominal in mm (in.)
(OD) and the inside diameter (ID) of the tube. For purposes of
Less than or equal to 1.5 (0.059) ±0.025 (0.001)
this specification, the sample minimum wall and the sample
1.5 to 6.5 (0.059 to 0.256) incl ±0.050 (0.002)
maximum wall measured on any one transverse cross section 6.5 to 10 (0.256 to 1.2) incl ±0.075 (0.003)
ofasinglesampleshallbeusedtocalculateconcentricity.Also,
for purposes of this specification, sample concentricity shall be
TABLE 3 Permissible Variation in Wall Thickness Dimensions
expressed as a percent and shall be calculated using the
Nominal Wall Thickness Permissible Wall
following equation:
Thickness Variation
A 2 B
Less than 0.2 mm (0.008 in.) ±0.025 mm (0.010 in.)
Sample concentricity percent 5 2 3 3100
F G
from nominal wall thickness
A1B
Greater than or equal to 0.2 mm ±12 % of
A
(0.008 in.) nominal wall thickness
where:
A
The ±12 % tolerance for a particular nominal wall thickness may be converted to
A = sample maximum wall, and
a decimal by multiplying 0.12 times the nominal wall thickness and rounding to the
B = sample minimum wall.
appropriate decimal place.
3.11 sample maximum wall thickness, n— the largest indi-
vidual wall thickness measurement taken around the circum-
ference on any one transverse cross section of a single sample
of tube.
5. Materials and Manufacture
3.11.1 Discussion—In practice, the sample maximum wall
5.1 Method of Manufacture:
thicknessmaybethelargestofnolessthanfourindividualwall
5.1.1 Seamless tube shall be made from bar, hollow bar, or
thickness measurements taken at uniformly spaced locations
tube raw material forms that meet the requirements of Speci-
around the circumference of a single sample of the tube.
fication F2063.
3.12 sample minimum wall thickness, n— the smallest
5.1.2 Seamless tube shall be made by a process in which the
individual wall thickness measurement taken around the cir-
tube periphery is continuous at all stages of the process.
cumference on any one transverse cross section of a single
5.2 Condition—Tube shall be furnished in the superelastic
sample of tube.
condition or as agreed upon between purchaser and supplier.
3.12.1 Discussion—In practice, the sample minimum wall
5.3 Surface Finish:
thickness may be the smallest of no less than four individual
wall thickness measurements taken at uniformly spaced loca- 5.3.1 The tube outer surface shall be furnished, as specified
by the purchaser, with a uniform, adherent oxide of any color,
tions around the circumference of a single sample of the tube.
pickled,ground,ormechanicallypolishedfinish.Otherfinishes
may be agreed upon between purchaser and supplier.
4. Ordering Information
5.3.2 The tube inner surface shall be furnished, as specified
4.1 Inquiries and orders for material under this specification
by the purchaser, with a uniform, adherent oxide of any color,
may include the following information:
pickled, or mechanically conditioned finish.
4.1.1 Quantity (total length or number of pieces),
5.3.3 Inner and outer surface roughness and the method of
4.1.2 This ASTM specification and date of issue,
measurement shall be as agreed upon between the purchaser
4.1.3 Condition (see 5.2),
and supplier.
4.1.4 Active Austenite Finish Temperature (see 7.2),
4.1.5 Mechanical Properties (see Table 1),
6. Chemical Composition
4.1.6 Surface Finish (see 5.3),
6.1 Seamless tube shall be made from bar, hollow bar, or
4.1.7 Nominal Dimensions including either OD and ID, OD
tube raw material forms that meet the chemical composition
and wall, or ID and wall,
requirements of Specification F2063.
4.1.8 Length (exact or random, see 9.4),
NOTE 1—Non-metallic inclusions shall be rated and reported on the
4.1.9 Dimensional Tolerances (see Table 2 and Table 3),
starting bar, hollow bar, or tube raw material forms by the raw material
4.1.10 Certification requirements (see Section 11), and
supplierperSpecificationF2063.Alternatenon-metallicinclusionrequire-
4.1.11 Specialrequirementsorsupplementaryrequirements,
ments and rating methods may be agreed upon between purchaser and
if any. supplier.
TABLE 1 Mechanical Properties
UTS Uniform Elongation Upper Plateau Strength Lower Plateau Strength Residual Elongation
Condition Min MPa (ksi) Min % in 50 mm (2 in.) or Min MPa (ksi) at 3 % Min MPa (ksi) at 2.5 % Max % after 6 % strain
4D strain strain
A B
Superelastic 1000 (145) 10 380 (55) 0.3 %
A
Superelastic properties are measured per Test Method F2516 at room temperature.
B
Lower plateau strength value may be measured and reported for information only.
F2633−07
6.2 Hydrogen content shall be analyzed and reported when be less than or equal to 10 %. For tube with nominal wall
required by the purchaser. The analysis shall be made on the thickness less than 0.2 mm (0.008 in.) or OD/W ratio greater
finished tube. than 15, concentricity shall be agreed upon between purchaser
and supplier.
7. Austenite Finish Temperature
9.3.2 This concentricity requirement does not apply to tube
7.1 The austenite finish temperature of the raw material specified as OD and ID unless agreed upon between purchaser
(ingotA ) shall be measured on fully annealed raw material by and supplier.
f
the raw material manufacturer per Test Method F2004 or Test 9.3.3 Alternate means of calculating and reporting concen-
Method F2082 as required in Specification F2063. tricity may be agreed upon between purchaser and supplier.
7.2 The austenite finish temperature of the finished tube
9.4 Length:
(active A ) with outer diameter in the range of 0.3 to 3.0 mm
9.4.1 For exact length orders, nominal length and length
f
(0.012 to 0.12 in.) shall be measured by the supplier on
variation shall be agreed upon between purchaser and supplier.
representative full round tube sample(s) using the bend and
9.4.2 For random length orders, a maximum and minimum
free recovery method described in Test Method F2082 when
length shall be agreed upon between purchaser and supplier.
required by the purchaser.
9.5 Straightness:
7.3 Alternate transfo
...