ASTM F2063-00
(Specification)Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
SCOPE
1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, wire, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants.
1.2 The values stated in SI units are to be regarded as the standard. The values given in inch-pound units are for information only.
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Designation: F 2063 – 00
Standard Specification for
Wrought Nickel-Titanium Shape Memory Alloys for Medical
Devices and Surgical Implants
This standard is issued under the fixed designation F 2063; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope Nickel-Titanium Alloys by Thermal Analysis
F 2005 Terminology for Nickel-Titanium Shape Memory
1.1 This specification covers the chemical, physical, me-
Alloys
chanical, and metallurgical requirements for wrought nickel-
F 2082 Method for the Determination of Transformation
titanium bar, wire, flat rolled products, and tubing containing
Temperature of Nickel-Titanium Shape MemoryAlloys by
nominally 54.5 % to 57.0 % nickel and used for the manufac-
Bend and Free Recovery
ture of medical devices and surgical implants.
2.2 ASQ Standard:
1.2 The values stated in SI units are to be regarded as the
C1 General Requirements for a Quality Program
standard. The values given in inch-pound units are for infor-
mation only.
3. Terminology
2. Referenced Documents 3.1 The terminology describing the physical and thermal
properties of these alloys shall be as defined in Terminology
2.1 ASTM Standards:
2 F 2005.
E 8 TestMethodsforTensionTestingofMetallicMaterials
3.2 E4: General Terminology
E 112 Test Method for Determining Average Grain Size
E 120 Test Method for Chemical Analysis of Titanium and
4. Product Classification
Titanium Alloys
4.1 bar—Round bars and flats from 5 mm (0.196 inches) to
E 1019 Test Method for Determination of Carbon, Sulfur,
130 mm (5.1 inches) in diameter or thickness (other sizes or
Nitrogen and Oxygen in Steel and in Iron, Nickel, and
shapes by special order).
Cobalt Alloys
4.2 plate—Any product 5 mm (0.196 inches) thick and over
E 1097 Guide for Direct Current Plasma Emission Spec-
and 250 mm (9.8 inches) wide and over, with width equal to or
trometry Analysis
greater than five times the thickness.
E 1172 Practice for Describing and Specifying a
4 4.3 strip—Any product under 5 mm (0.196 inches) thick
Wavelength-Dispersive X-Ray Spectrometer
and under 600 mm (23.6 inches) wide.
E 1245 Practice for Determining the Inclusion or Second-
4.4 sheet—Any product under 5 mm (0.196 inches) thick
Phase Constituent Content of Metals by Automatic Image
2 and 600 mm (23.6 inches) or more wide.
Analysis
4.5 wire—Rounds less than 5 mm (0.196 inches) in diam-
E 1409 Test Method for Determination of Oxygen in Tita-
eter.
nium and Titanium Alloys by the Inert Gas Fusion Tech-
4 4.6 tubing—Hollow cylindrical shapes up to 50 mm (1.96
nique
inches) in outside diameter.
E 1447 Test Method for Determination of Hydrogen in
Titanium and Titanium Alloys by the Inert Gas Fusion
5. Ordering Information
Thermal Conductivity Method
5.1 Inquiries and orders for material under this specification
E 1479 Practice for Describing and Specifying Inductively-
4 shall include the following information:
Coupled Plasma Optical Emission Spectrometers
5.1.1 Quantity: weight, length, or number of pieces.
F 2004 Test Method for Transformation Temperature of
5.1.2 Alloyformulation,intermsoftransformationtempera-
ture parameter (see Section 8).
5.1.3 Form: bar, plate, strip, sheet, wire, or tubing (see
This specification is under the jurisdiction of ASTM Committee F04 on Section 4).
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 10, 2000. Published February 2001.
2 5
Annual Book of ASTM Standards, Vol 03.01. Annual Book of ASTM Standards, Vol 13.01.
3 6
Annual Book of ASTM Standards, Vol 03.05. Available from the American Society for Quality, 611 East Wisconsin Ave.,
Annual Book of ASTM Standards, Vol 03.06. Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 2063
5.1.4 Condition (see Sections 6.3 and 10.1). 7.4 Product analysis limits shall be as specified in Table 2.
5.1.5 Mechanical Properties, if applicable for special con- Product analysis tolerances do not broaden the specification
ditions (see Section 10). heat analysis requirements, but cover variation between labo-
5.1.6 Surface Condition (see Sections 6.4). ratories in the measurement of chemical content. The manu-
5.1.7 ApplicableDimensions, including diameter, thickness, facturer shall not ship material that is outside the limits
width, spool size, coil diameter, and length (exact, random, specified in Table 1.
multiples) or print number.
8. Transformation Temperature
5.1.8 Special Tests, for example, chemical analysis on the
finished mill product.
8.1 The nickel and titanium contents of nickel-titanium
5.1.9 Special Requirements (see section 11).
shape memory alloys cannot be measured to a precision
required to guarantee shape memory or superelastic properties.
6. Manufacture
Calorimetry or an equivalent thermomechanical test method
6.1 Thematerialshallbemadefromingotmadefromnickel
must be used to assure the alloy formulation in terms of
and titanium with no other intentional alloy additions.
transformation temperature.
6.2 The material shall be vacuum or inert atmosphere
8.2 Alloy formulation shall be specified in terms of the
meltedtocontrolmetallurgicalcleanlinessandalloychemistry.
transformation temperature parameter(s) required by the pur-
6.3 Bar, plate, tubing, wire, and flat rolled products shall be
chase order. This parameter shall be one of the following: M ,
f
supplied as hot finished or cold finished and annealed or heat
M,M,A,A,A as defined in Terminology F 2005 and as
p s s p f
treated as specified in the purchase order.
measured in accordance with Method F 2004, Method F 2082
6.4 Surface condition may be oxidized, descaled, pickled,
or as measured in accordance with another appropriate ther-
blasted, machined, ground, mechanically polished, or elec-
momechanical test method.
tropolished.
8.3 When measured in accordance with Method F 2004 for
transformation temperature by thermal analysis, theA shall be
s
7. Chemical Composition
uniform to within 610°C on the purchased product or as
7.1 The heat analysis shall conform to the requirements of
agreed upon by the customer and supplier.
Table 1. Ingot analysis may be used for reporting all chemical
8.4 Transformation temperature parameters are normally
requirements except hydrogen. Samples for hydrogen analysis
specified in the wrought product in the annealed condition as
shall be taken from the finished mill product see Section 4 or
definedinF 2005.Otherconditionsforthecertificationofalloy
as agreed upon between the customer and supplier. The
transformation temperature shall be considered a special re-
supplier shall not ship material that is outside the limits
quirement.
specified in Table 1
7.1.1 Requirements for major and minor elements are listed 9. Metallurgical Structure
inTable1.Importantresidualelementsarealsolisted.Analysis
9.1 Microstructure:
for elements not listed in Table 1 is not required to verify
9.1.1 Annealed product 6 mm (0.236 in.) to 50 mm (1.96
compliance with this specification.
in.) in section shall have a grain size of ASTM 4 or finer as
7.2 Analytical Methods—Major elements shall be analyzed
measured by Test Method E 112.
by direct current plasma spectrometry according to Guide
9.2 Non-metallic Inclusions and Porosity:
E 1097; atomic absorption, inductively coupled plasma spec-
9.2.1 For all mill products, porosity and nonmetallic inclu-
trometry according to Practice E 1479; X-ray spectrometer
sionssuchasTi Ni O andTiCparticlesshallbenolargerthan
4 2 x
according to Practice E 1172 or an equivalent method. Carbon
12.5 µm (0.0005 in.). Furthermore, porosity and nonmetallic
shall be measured by combustion according to Test Method
inclusions shall not constitute more than 1.0 % (area percent)
E 1019. Hydrogen shall be measured by inert gas fusion or
ofthestructureasviewedat400Xto500Xinanyfieldofview.
vacuum hot extraction according to Test Methods E 120 or
Porosity and nonmetallic inclusions shall be evaluated in mill
E 1447. Nitrogen and oxygen shall be measured by inert gas
fusion according to Test Method E 1409.
A
TABLE 2 Product Analysis Tolerance
7.3 The titanium content of these alloys shall be determined
Element Tolerance Under the Minimum or
by difference and need not be analyzed.
Over the Maximum, (wt. %)
Nickel 0.2
TABLE 1 Chemical Requirements
Element Tolerance Over the Maximum,
Element Weight Percent
(wt. %)
Nickel 54.5 to 57.0
Carbon 0.002
Carbon, maximum 0.070
Cobalt 0.001
Cobalt, maximum 0.050
Copper 0.001
Copper, maximum 0.010
Chromium 0.001
Chromium, maximum 0.010
Hydrogen 0.0005
Hydrogen, maximum 0.005
Iron 0.01
Iron, maximum 0.050
Niobium 0.004
Niobium,
...
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