ASTM F2063-18

Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

ABSTRACT
This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions. The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or cold finished and annealed or heat treated. Surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished. Major elements shall be analyzed by direct current plasma spectrometry, atomic absorption, inductively coupled plasma spectrometry, X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method. Carbon shall be measured by combustion and hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured by inert gas fusion. The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method must be used to assure the alloy formulation in terms of transformation temperature. Mechanical properties of the samples such as tensile strength and elongation shall be determined after annealing.
SCOPE
1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubes containing nominally 54.5- to 57.0-weight percent nickel and used for the manufacture of medical devices and surgical implants.  
1.2 Requirements are for mill product, measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components. Finished NiTi cold-worked tube should be considered under Specification F2633.  
1.3 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.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Jul-2018
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F2063-12 - Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
• Effective Date: 01-Aug-2018
• Refers: ASTM E8/E8M-24 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jan-2024
• Refers: ASTM E2465-23 - Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
• Effective Date: 01-Nov-2023
• Refers: ASTM E2465-19 - Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
• Effective Date: 01-Oct-2019
• Refers: ASTM F2004-17 - Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
• Effective Date: 01-Oct-2017
• Refers: ASTM F2004-16 - Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
• Effective Date: 01-Dec-2016
• Refers: ASTM E1479-16 - Standard Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers
• Effective Date: 01-Nov-2016
• Refers: ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 15-Jul-2016
• Refers: ASTM F1710-08(2016) - Standard Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer (Withdrawn 2023)
• Effective Date: 01-May-2016
• Refers: ASTM F2082-15 - Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
• Effective Date: 01-May-2015
• Refers: ASTM E8/E8M-15 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Feb-2015
• Refers: ASTM E4-14 - Standard Practices for Force Verification of Testing Machines
• Effective Date: 01-Jun-2014
• Refers: 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
• Refers: ASTM E2465-13 - Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
• Effective Date: 01-Jun-2013
• Refers: ASTM E8/E8M-13 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jun-2013

Overview

ASTM F2063-18: Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants defines the requirements for nickel-titanium (NiTi, also known as nitinol) alloys used in the production of medical devices and surgical implants. This standard covers the chemical, physical, mechanical, and metallurgical properties of wrought bar, flat rolled products, and tubing containing nominally 54.5% to 57.0% nickel, specifically for use in the medical industry. ASTM F2063-18 ensures that these materials meet strict quality, cleanliness, and performance criteria essential for safety and reliability in biomedical applications.

Key Topics

• Scope and Material Forms: The specification applies to mill products (bar, plate, tube) of wrought NiTi alloys with a diameter or thickness of 5.50 to 94.0 mm, produced via vacuum or inert atmosphere melting to ensure metallurgical cleanliness.
• Chemical Composition: Nominal nickel content ranges from 54.5% to 57.0%, with titanium as the balance. Strict limits are imposed on residual elements such as carbon, cobalt, copper, hydrogen, iron, niobium, nitrogen, and oxygen.
• Mechanical and Physical Properties: After annealing, products are required to meet minimum tensile strength and elongation criteria, ensuring suitability for demanding medical applications. Transformation temperature parameters must be determined by calorimetry or equivalent methods.
• Metallurgical Structure: Microstructure and microcleanliness, including grain size and inclusions, are precisely evaluated according to specified methods, ensuring the alloy’s integrity.
• Surface Conditions: Finished materials can be supplied with various surface finishes, such as oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished surfaces.
• Testing and Analysis: Chemical analysis for major and minor elements is performed using advanced spectrometry and fusion techniques. Mechanical testing follows established tensile and elongation standards.

Applications

Nickel-titanium alloys standardized under ASTM F2063-18 are widely utilized in the manufacture of:

• Medical Devices: Including guidewires, orthodontic archwires, and endodontic instruments that benefit from the unique superelastic and shape memory properties of nitinol.
• Surgical Implants: Such as stents, bone anchors, and various cardiovascular devices, where biocompatibility, fatigue resistance, and consistent transformation temperatures are critical.
• Orthopedic and Vascular Applications: NiTi alloys enable minimally invasive interventions and implantable devices that conform to dynamic biological environments.
• Other Biomedical Uses: Where reliable performance, long-term durability, and specific transformation temperatures are required.

The alloys’ well-characterized biocompatibility and corrosion resistance, in combination with robust documentation and quality controls specified by the standard, make them especially suitable for long-term and critical healthcare products.

Related Standards

ASTM F2063-18 references and aligns with several other important standards to provide comprehensive material and testing guidance for medical device manufacturers, including:

• ASTM F2633: Specification for wrought seamless nickel-titanium tube specifically for medical devices and surgical implants.
• ASTM F2005: Terminology standard for nickel-titanium shape memory alloys.
• ASTM F2004: Test method for transformation temperature by thermal analysis.
• ASTM E8/E8M: Test methods for tension testing of metallic materials.
• ISO 9001: Quality management systems requirements.
• ASTM E4, E29, E112, E1019, E1097, E1409, E1447, E1479, E1941, E2465: Widely used standards for mechanical testing, chemical analysis, and metrological conformity.
• IEEE/ASTM SI 10: American national standard for metric practice.

By adhering to ASTM F2063-18 and its referenced standards, manufacturers and regulatory bodies can ensure consistent, high-quality production and verification of nickel-titanium alloy components for use in advanced medical and surgical applications.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F2063 −18
Standard Specification for
Wrought Nickel-Titanium Shape Memory Alloys for Medical
Devices and Surgical Implants
This standard is issued under the fixed designation F2063; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E112Test Methods for Determining Average Grain Size
E1019Test Methods for Determination of Carbon, Sulfur,
1.1 This specification covers the chemical, physical,
Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt
mechanical, and metallurgical requirements for wrought
Alloys by Various Combustion and Inert Gas Fusion
nickel-titanium bar, flat rolled products, and tubes containing
Techniques
nominally 54.5- to 57.0-weight percent nickel and used for the
E1097Guide for Determination of Various Elements by
manufacture of medical devices and surgical implants.
Direct Current Plasma Atomic Emission Spectrometry
1.2 Requirements are for mill product, measuring 5.50 to
E1172Practice for Describing and Specifying a Wavelength
94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill
Dispersive X-Ray Spectrometer
product is not intended to have the final shape, final surface
E1245Practice for Determining the Inclusion or Second-
finish, or final properties of the medical device, implant, or
Phase Constituent Content of Metals byAutomatic Image
their components. Finished NiTi cold-worked tube should be
Analysis
considered under Specification F2633.
E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
1.3 The values stated in either SI units or inch-pound units
are to be regarded separately as standard. The values stated in E1447Test Method for Determination of Hydrogen in Tita-
nium and Titanium Alloys by Inert Gas Fusion Thermal
each system may not be exact equivalents; therefore, each
system shall be used independently of the other. Combining Conductivity/Infrared Detection Method
E1479Practice for Describing and Specifying Inductively
values from the two systems may result in non-conformance
with the standard. Coupled Plasma Atomic Emission Spectrometers
E1941Test Method for Determination of Carbon in Refrac-
1.4 This international standard was developed in accor-
toryandReactiveMetalsandTheirAlloysbyCombustion
dance with internationally recognized principles on standard-
Analysis
ization established in the Decision on Principles for the
E2465Test Method for Analysis of Ni-Base Alloys by
Development of International Standards, Guides and Recom-
WavelengthDispersiveX-RayFluorescenceSpectrometry
mendations issued by the World Trade Organization Technical
F1710Test Method for Trace Metallic Impurities in Elec-
Barriers to Trade (TBT) Committee.
tronic Grade Titanium by High Mass-Resolution Glow
Discharge Mass Spectrometer
2. Referenced Documents
2 F2004Test Method for Transformation Temperature of
2.1 ASTM Standards:
Nickel-Titanium Alloys by Thermal Analysis
E4Practices for Force Verification of Testing Machines
F2005Terminology for Nickel-Titanium Shape Memory
E8/E8MTest Methods for Tension Testing of Metallic Ma-
Alloys
terials
F2082Test Method for Determination of Transformation
E29Practice for Using Significant Digits in Test Data to
Temperature of Nickel-Titanium Shape Memory Alloys
Determine Conformance with Specifications
by Bend and Free Recovery
F2633Specification for Wrought Seamless Nickel-Titanium
This specification is under the jurisdiction of ASTM Committee F04 on
Shape Memory Alloy Tube for Medical Devices and
Medical and Surgical Materials and Devices and is the direct responsibility of
Surgical Implants
Subcommittee F04.12 on Metallurgical Materials.
IEEE/ASTM SI 10American National Standard for Metric
Current edition approved Aug. 1, 2018. Published August 2018. Originally
approved in 2000. Last previous edition approved in 2012 as F2063–12. DOI: Practice
10.1520/F2063–18.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2063−18
2.2 ISO Standard: 6.4 The product surface condition may be oxidized,
ISO 9001Quality Management Systems—Requirements descaled, pickled, blasted, machined, ground, mechanically
polished, or electropolished.
3. Terminology
7. Chemical Composition Requirements
3.1 The terminology describing the physical and thermal
7.1 The ingot analysis shall conform to the requirements of
properties of these alloys shall be as defined in Terminology
Table 1. Ingot analysis may be used for reporting all chemical
F2005.
requirements except hydrogen. Samples for hydrogen analysis
3.2 See also Practice E4 (General Terminology).
shall be taken from the finished product (see Section 4)oras
agreed upon between the customer and supplier. The supplier
3.3 Definitions:
shall not ship material that is outside the limits specified in
3.3.1 ingot, n—quantity of metal cast into a shape suitable
Table 1.
for subsequent processing to various mill products.
7.1.1 Requirements for major and minor elements are listed
3.3.2 mill product, n—any finished or semi-finished product
inTable1.Importantresidualelementsarealsolisted.Analysis
from a mill. Product may be straight or coiled. Product types
for elements not listed in Table 1 is not required to verify
include hot-worked, hot-worked and cold-finished, and hot-
compliance with this specification.
worked and cold-worked, with or without a final heat treat-
ment. 7.2 Product Analysis:
7.2.1 ProductanalysislimitsshallbeasspecifiedinTable2.
4. Product Classification Product analysis tolerances do not broaden the specification
ingot analysis requirements, but cover variation between labo-
4.1 Bar—Roundbarsandflatsfrom5.50to94.0mm[0.218
ratories in the measurement of chemical content. The manu-
to 3.70 in.] in diameter or thickness (other sizes or shapes by
facturer shall not ship material that is outside the limits
special order).
specified in Table 1.
4.2 Plate—Any product 5.50 up to 94.0 mm [0.218 to 3.70
7.2.2 The product analysis is either for the purpose of
in.]inthickness,withawidthequaltoorgreaterthanfivetimes
verifying the composition of an ingot or manufacturing lot or
the thickness.
to determine variations in the composition within the ingot.
7.2.3 Acceptance or rejection of an ingot or manufacturing
4.3 Tube—Hollow cylindrical shapes from 5.50 up to 94.0
mm [0.218 to 3.70 in.] in outer diameter. lot of material may be made by the purchaser on the basis of
this product analysis. Product analysis may be conducted by a
5. Ordering Information third party if agreed upon by the supplier and the purchaser.
7.2.4 Major elements shall be analyzed by direct current
5.1 Inquiriesandordersformaterialunderthisspecification
plasma spectrometry according to Guide E1097; atomic
shall include the following information:
absorption, inductively coupled plasma spectrometry accord-
5.1.1 Quantity—weight, length, or number of pieces.
ing to Practice E1479; X-ray spectrometer according to Prac-
5.1.2 Alloy formulation,intermsoftransformationtempera-
tice E1172; glow discharge mass spectrometry according to
ture parameter (see Section 8).
Test Method F1710; or an equivalent method. Carbon shall be
5.1.3 Form—bar, plate, or tube (see Section 4).
measured by combustion according toTest MethodS E1019 or
5.1.4 Condition—(see 3.3).
E1941 or wavelength dispersive X-ray fluorescence spectrom-
5.1.5 Mechanical Properties—if applicable for special con-
etry according to Test Method E2465. Hydrogen shall be
ditions (see Section 10).
measured by inert gas fusion or vacuum hot extraction.
5.1.6 Surface Condition—(see Section 6.4).
Hydrogenshallbemeasuredbyinertgasfusionorvacuumhot
5.1.7 Applicable Dimensions,includingdiameter,thickness,
extraction according to Test Method E1447. Nitrogen and
width, and length (exact, random, multiples) or print number.
oxygenshallbemeasuredbyinertgasfusionaccordingtoTest
5.1.8 Special Tests—for example, chemical analysis on the
Method E1409.
finished mill product.
5.1.9 Special Requirements—(see Section 13).
TABLE 1 Chemical Composition Requirements
Element % (mass/mass)
6. Materials and Manufacture
Nickel 54.5 to 57.0
Carbon, maximum 0.040
6.1 Thematerialshallbemadefromingotmadefromnickel
Cobalt, maximum 0.050
and titanium with no other intentional alloy additions.
Copper, maximum 0.010
Chromium, maximum 0.010
6.2 The material shall be vacuum or inert atmosphere
Hydrogen, maximum 0.005
meltedtocontrolmetallurgicalcleanlinessandalloychemistry.
Iron, maximum 0.050
Niobium, maximum 0.025
6.3 The product shall be supplied as specified in the
Nitrogen, maximum 0.005
purchase order. Oxygen, maximum 0.040
A
Titanium Balance
A
Approximately equal to the difference between 100 % and the sum percentage
of the other specified elements. The percentage titanium content by difference is
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
not required to be reported.
4th Floor, New York, NY 10036, http://www.ansi.org.
F2063−18
A
TABLE 2 Product Analysis Tolerance
8.3 Section size, location, evaluation method, and results
Element Tolerance Under the Minimum Limit
shallbereportedontheproductcertificationreportprovidedto
or Over the Maximum Limit,
the purchaser.
B
% (mass/mass)
Carbon 0.002
Cobalt 0.001
9. Metallurgical Structure
Copper 0.001
9.1 Microstructure:
Chromium 0.001
Hydrogen 0.0005
9.1.1 Microstructure shall be evaluated only in the hot-
Iron 0.01
worked or annealed condition. Such evaluations shall take
Nickel 0.2 under min; 0.2 over max
place at a section size not larger than 94.0 mm [3.70 in.] and
Niobium 0.004
Nitrogen 0.001
not smaller than 5.50 mm [0.218 in.] in diameter, thickness,
Oxygen 0.004
width, height, wall thickness, or other maximum dimension.
A
Product analysis tolerance limits are based on analytical capabilities that have
Evaluation may take place on in-process product that will be
been demonstrated for this composition.
B
utilized to create the final product form. Condition, section
Under minimum limit not applicable for elements where only a maximum
percentage is indicated.
size, location, and evaluation method shall be reported on the
product certification report provided to the purchaser.
9.1.2 Forallproductevaluatedasstatedin9.1.1,theproduct
shall have an average grain size number (G) of 4 or larger as
measured by Test Method E112. Results shall be reported on
7.2.5 The titanium content of these alloys shall be deter-
the product certification report provided to the purchaser.
mined by difference and need not be analyzed.
9.2 Microcleanliness:
8. Transformation Temperature
9.2.1 Porosityandnonmetallicinclusionsshallbeevaluated
only in the hot-worked, or for cold-worked mill product in the
8.1 The nickel and titanium contents of nickel-titanium
annealed condition, or as agreed between the supplier and
shape memory alloys cannot be measured to a precision
purchaser. Such evaluations shall take place at a section size
requiredtoguaranteeshapememoryorsuperelasticproperties.
not larger than 94.0 mm [3.70 in.] and not smaller than 5.50
Calorimetry or an equivalent thermomechanical test method
mm [0.218 in.] in diameter, thickness, width, height, wall
shall be used to ensure the alloy formulation in terms of
thickness, or other maximum dimension. Evaluation may take
transformation temperature. Testing shall be performed on
place on in-process product that will be utilized to create the
material in the fully annealed condition.
final product form. Condition, section size, location, and
8.2 Product alloy formulation shall be specified in terms of
evaluationmethodshallbereportedontheproductcertification
the transformation temperature parameter(s) required by the
report provided to the purchaser.
purchase order. This parameter shall be one of the following:
9.2.2 For product with A less than or equal to 30°C, the
s
M,M,M,A,A ,A asdefinedinTerminologyF2005andas
f p s s p f
maximum allowable dimension of porosity and nonmetallic
measured on the product in accordance with Test Method
inclusionssuchasTi Ni O andTiCparticlesshallbe39.0µm
4 2 x
F2004, or as measured in accordance with another appropriate
[0.0015 in.]. The maximum dimension shall be the maximum
thermomechanical test method, such as Test Method F2082.
lengthofallcontiguousparticlesandvoids,includingparticles
Test Method F2004 shall be used to determine transformation
separated by voids. Furthermore, porosity and nonmetallic
temperaturesunlessotherwiseagreedbetweenthesupplierand
inclusions shall not constitute more than 2.8% (area percent)
purchaser.
ofthestructureasviewedat400×to500×inanyfieldofview.
8.2.1 When measured in accordance with Test Method
9.2.3 For product withA greater than 30°C, the maximum
s
F2004 for transformation temperature by thermal analysis, the
allowable dimensions of porosity and nonmetallic inclusions
A shall be uniform on the purchased product to within the
s
suchasTi Ni O andTiCparticlesshallbeagreeduponbythe
4 2
...

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: F2063 − 12 F2063 − 18
Standard Specification for
Wrought Nickel-Titanium Shape Memory Alloys for Medical
Devices and Surgical Implants
This standard is issued under the fixed designation F2063; 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*
1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium
bar, flat rolled products, and tubes containing nominally 54.5- to 57.0-weight percent nickel and used for the manufacture of
medical devices and surgical implants.
1.2 Requirements are for mill product, measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product
is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components.
Finished NiTi cold-worked tube should be considered under Specification F2633.
1.3 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.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
E1019 Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by
Various Combustion and Inert Gas Fusion Techniques
E1097 Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry
E1172 Practice for Describing and Specifying a Wavelength Dispersive X-Ray Spectrometer
E1245 Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1479 Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E2465 Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
F1710 Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass
Spectrometer
F2004 Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
F2005 Terminology for Nickel-Titanium Shape Memory Alloys
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2012Aug. 1, 2018. Published January 2013August 2018. Originally approved in 2000. Last previous edition approved in 20052012 as
F2063 – 05.F2063 – 12. DOI: 10.1520/D2063–12.10.1520/F2063–18.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2063 − 18
F2082 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and
Free Recovery
F2633 Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical
Implants
IEEE/ASTM SI 10 American National Standard for Metric Practice
2.2 Other Standards:ISO Standard:
ASQ C1 General Requirements for a Quality Program
ISO 9001 Quality Management Systems—Requirements
3. Terminology
3.1 The terminology describing the physical and thermal properties of these alloys shall be as defined in Terminology F2005.
3.2 See also Practice E4: General Terminology. (General Terminology).
3.3 Definitions:
3.3.1 ingot, n—quantity of metal cast into a shape suitable for subsequent processing to various mill products.
3.3.2 mill product, n—any finished or semi-finished product from a mill. Product may be straight or coiled. Product types
include hot-worked, hot-worked and cold-finished, and hot-worked and cold-worked, with or without a final heat treatment.
NOTE 1—Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components.
4. Product Classification
4.1 Bar—Round bars and flats from 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness (other sizes or shapes by special
order).
4.2 Plate—Any product 5.50 up to 94.0 mm [0.218 to 3.70 in.] in thickness, with a width equal to or greater than five times
the thickness.
4.3 Tube—Hollow cylindrical shapes from 5.50 up to 94.0 mm [0.218 to 3.70 in.] in outer diameter.
5. Ordering Information
5.1 Inquiries and orders for material under this specification shall include the following information:
5.1.1 Quantity—weight, length, or number of pieces.
5.1.2 Alloy formulation, in terms of transformation temperature parameter (see Section 8).
5.1.3 Form—bar, plate, or tube (see Section 4).
5.1.4 Condition—(see 3.3.13.3).
5.1.5 Mechanical Properties—if applicable for special conditions (see Section 10).
5.1.6 Surface Condition—(see SectionsSection 6.4).
5.1.7 Applicable Dimensions, including diameter, thickness, width, and length (exact, random, multiples) or print number.
5.1.8 Special Tests—for example, chemical analysis on the finished mill product.
5.1.9 Special Requirements—(see Section 13).
6. Materials and Manufacture
6.1 The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions.
6.2 The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry.
6.3 The product shall be supplied as specified in the purchase order.
6.4 The product surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or
electropolished.
7. Chemical Composition Requirements
7.1 The heatingot analysis shall conform to the requirements of Table 1. Ingot analysis may be used for reporting all chemical
requirements except hydrogen. Samples for hydrogen analysis shall be taken from the finished product (see Section 4) or as agreed
upon between the customer and supplier. The supplier shall not ship material that is outside the limits specified in Table 1.
7.1.1 Requirements for major and minor elements are listed in Table 1. Important residual elements are also listed. Analysis for
elements not listed in Table 1 is not required to verify compliance with this specification.
7.2 Product Analysis:
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.Available from American Society for Quality (ASQ), 600 N.
Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F2063 − 18
TABLE 1 Chemical Composition Requirements
Element % (mass/mass)
Nickel 54.5 to 57.0
Carbon, maximum 0.050
Carbon, maximum 0.040
Cobalt, maximum 0.050
Copper, maximum 0.010
Chromium, maximum 0.010
Hydrogen, maximum 0.005
Iron, maximum 0.050
Niobium, maximum 0.025
Nitrogen, maximum 0.005
Nitrogen plus Oxygen, maximum 0.050
Oxygen, maximum 0.040
A
Titanium Balance
A
Approximately equal to the difference between 100 % and the sum percentage
of the other specified elements. The percentage titanium content by difference is
not required to be reported.
7.2.1 Product analysis limits shall be as specified in Table 2. Product analysis tolerances do not broaden the specification
heatingot analysis requirements, but cover variation between laboratories in the measurement of chemical content. The
manufacturer shall not ship material that is outside the limits specified in Table 1.
7.2.2 The product analysis is either for the purpose of verifying the composition of a heatan ingot or manufacturing lot or to
determine variations in the composition within the heat.ingot.
7.2.3 Acceptance or rejection of a heatan ingot or manufacturing lot of material may be made by the purchaser on the basis of
this product analysis. Product analysis may be conducted by a third party if agreed upon by the supplier and the purchaser.
7.2.4 Major elements shall be analyzed by direct current plasma spectrometry according to Guide E1097; atomic absorption,
inductively coupled plasma spectrometry according to Practice E1479; X-ray spectrometer according to Practice E1172; glow
discharge mass spectrometry according to Test Method F1710; or an equivalent method. Carbon shall be measured by combustion
according to Test MethodMethodS E1019 or E1941 or wavelength dispersive X-ray fluorescence spectrometry according to Test
Method E2465. Hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Hydrogen shall be measured by inert
gas fusion or vacuum hot extraction according to Test Method E1447. Nitrogen and oxygen shall be measured by inert gas fusion
according to Test Method E1409.
7.2.5 The titanium content of these alloys shall be determined by difference and need not be analyzed.
8. Transformation Temperature
8.1 The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to
guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method shall be used to
ensure the alloy formulation in terms of transformation temperature. Testing shall be performed on material in the fully annealed
condition.
8.2 Product alloy formulation shall be specified in terms of the transformation temperature parameter(s) required by the
purchase order. This parameter shall be one of the following: M , M , M , A , A , A as defined in Terminology F2005 and as
f p s s p f
measured on the product in accordance with Test Method F2004, or as measured in accordance with another appropriate
A
TABLE 2 Product Analysis Tolerance
Element Tolerance Under the Minimum Limit
or Over the Maximum Limit,
B
% (mass/mass)
Carbon 0.002
Cobalt 0.001
Copper 0.001
Chromium 0.001
Hydrogen 0.0005
Iron 0.01
Nickel 0.2 under min; 0.2 over max
Niobium 0.004
Nitrogen 0.004
Nitrogen 0.001
Oxygen 0.004
A
Product analysis tolerance limits are based on analytical capabilities that have
been demonstrated for this composition.
B
Under minimum limit not applicable for elements where only a maximum
percentage is indicated.
F2063 − 18
thermomechanical test method.method, such as Test Method F2082. Test Method F2004 shall be used to determine transformation
temperatures unless otherwise agreed between the supplier and purchaser.
8.2.1 When measured in accordance with Test Method F2004 for transformation temperature by thermal analysis, the A shall
s
be uniform on the purchased product to within the ranges in Table 3 or as agreed upon by the purchaser and supplier.
8.2.2 Table 3 tolerances are for A only. Tolerances for M , M , M , A , and A are as agreed upon by the purchaser and supplier.
s f p s p f
8.2.3 Transformation temperature parameters are normally specified in the wrought product as defined in Terminology F2005.
Other conditions for the certification of alloy transformation temperature shall be considered a special requirement.
8.3 Section size, location, evaluation method, and results shall be reported on the product certification report provided to the
purchaser.
9. Metallurgical Structure
9.1 Microstructure:
9.1.1 Microstructure shall be evaluated only in the hot-worked condition, prior to any cold processing. or annealed condition.
Such evaluations shall take place at a section size not larger than 94.0 mm [3.70 in.] and not smaller than 5.50 mm [0.218 in.] in
diameter, thickness, width, height, wall thickness, or other maximum dimension. Evaluation may take place on in-process product
that will be utilized to create the final product form. Condition, section size, location, and evaluation method shall be reported on
the product certification report provided to the purchaser.
9.1.2 For all product evaluated as stated in 9.1.1, the product shall have an average grain size number (G) of 4 or larger as
measured by Test Method E112. Results shall be reported on the product certification report provided to the purchaser.
9.2 Microcleanliness:
9.2.1 Porosity and nonmetallic inclusions shall be evalutedevaluated only in the hot-worked condition, prior to any cold
processing. hot-worked, or for cold-worked mill product in the annealed condition, or as agreed between the supplier and
purchaser. Such evaluations shall take place at a section size not larger than 94.0 mm [3.70 in.] and not smaller than 5.50 mm
[0.218 in.] in diameter, thickness, width, height, wall thickness, or other maximum dimension. Evaluation may take place on
in-process product that will be utilized to create the final product form. Condition, section size, location, and evaluation method
shall be reported on the product certification report provided to the purchaser.
9.2.2 For product with A less than or equal to 30°C, the maximum allowable dimension of porosity and
...