ASTM F2063-12
(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
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.] 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.
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Designation:F2063 −12
Standard Specification for
Wrought Nickel-Titanium Shape Memory Alloys for Medical
1
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* E1172PracticeforDescribingandSpecifyingaWavelength-
Dispersive X-Ray Spectrometer
1.1 This specification covers the chemical, physical,
E1245Practice for Determining the Inclusion or Second-
mechanical, and metallurgical requirements for wrought
Phase Constituent Content of Metals byAutomatic Image
nickel-titanium bar, flat rolled products, and tubes containing
Analysis
nominally 54.5- to 57.0-weight percent nickel and used for the
E1409TestMethodforDeterminationofOxygenandNitro-
manufacture of medical devices and surgical implants.
gen in Titanium and Titanium Alloys by the Inert Gas
1.2 Requirements are for mill product, measuring 5.50 to
Fusion Technique
94.0mm[0.218to3.70in.]diameterorthickness.Millproduct
E1447Test Method for Determination of Hydrogen in Tita-
is not intended to have the final shape, final surface finish, or
nium and Titanium Alloys by Inert Gas Fusion Thermal
final properties of the medical device, implant, or their com-
Conductivity/Infrared Detection Method
ponents.FinishedNiTicold-workedtubeshouldbeconsidered
E1479Practice for Describing and Specifying Inductively-
under Specification F2633.
Coupled Plasma Atomic Emission Spectrometers
E1941Test Method for Determination of Carbon in Refrac-
1.3 The values stated in either SI units or inch-pound units
are to be regarded separately as standard. The values stated in toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
each system may not be exact equivalents; therefore, each
system shall be used independently of the other. Combining F1710Test Method for Trace Metallic Impurities in Elec-
tronic Grade Titanium by High Mass-Resolution Glow
values from the two systems may result in non-conformance
with the standard. Discharge Mass Spectrometer
F2004Test Method for Transformation Temperature of
2. Referenced Documents
Nickel-Titanium Alloys by Thermal Analysis
2
F2005Terminology for Nickel-Titanium Shape Memory
2.1 ASTM Standards:
Alloys
E4Practices for Force Verification of Testing Machines
F2633Specification for Wrought Seamless Nickel-Titanium
E8/E8MTest Methods for Tension Testing of Metallic Ma-
Shape Memory Alloy Tube for Medical Devices and
terials
Surgical Implants
E29Practice for Using Significant Digits in Test Data to
IEEE/ASTM SI 10American National Standard for Metric
Determine Conformance with Specifications
Practice
E112Test Methods for Determining Average Grain Size
2.2 Other Standards:
E1019Test Methods for Determination of Carbon, Sulfur,
3
ASQ C1General Requirements for a Quality Program
Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt
4
ISO 9001Quality Management Systems—Requirements
Alloys by Various Combustion and Fusion Techniques
E1097Guide for Determination of Various Elements by
3. Terminology
Direct Current Plasma Atomic Emission Spectrometry
3.1 The terminology describing the physical and thermal
properties of these alloys shall be as defined in Terminology
1
This specification is under the jurisdiction of ASTM Committee F04 on
F2005.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. 3.2 See also Practice E4: General Terminology.
Current edition approved Dec. 1, 2012. Published January 2013. Originally
approved in 2000. Last previous edition approved in 2005 as F2063–05. DOI:
3
10.1520/D2063–12. Available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve.,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Milwaukee,WI 53203.Available fromAmerican Society for Quality (ASQ), 600 N.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
*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
1
---------------------- Page: 1 ----------------------
F2063−12
TABLE 1 Chemical Composition Requirements
3.3 Definitions:
3.3.1 mill product, n—any finished or semi-finished product Element % (mass/mass)
Nickel 54.5 to 57.0
from a mill. Pr
...
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 − 05 F2063 − 12
Standard Specification for
Wrought Nickel-Titanium Shape Memory Alloys for Medical
1
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 tubingtubes containing nominally 54.5 %54.5- to 57.0 % 57.0-weight percent nickel and used for the
manufacture of medical devices and surgical implants.
1.2 Requirements are for mill product, measuring 65.50 to 13094.0 mm (0.24[0.218 to 5.12 in.) diameter or thickness, in its
annealed condition.3.70 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 the standard. The values given in
inch-pound units are for information only.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.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
E8E8/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 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 the Inert Gas Fusion
Technique
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
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
F2082F2633 Test Method for Determination of Transformation Temperature of Specification for Wrought Seamless Nickel-
Titanium Shape Memory Alloys by Bend and Free RecoveryAlloy Tube for Medical Devices and Surgical Implants
IEEE/ASTM SI 10 American National Standard for Metric Practice
1
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 Nov. 1, 2005Dec. 1, 2012. Published November 2005January 2013. Originally approved in 2000. Last previous edition approved in 20002005
as F2063 – 00.F2063 – 05. DOI: 10.1520/D2063–05.10.1520/D2063–12.
2
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.
*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
1
---------------------- Page: 1 ----------------------
F2063 − 12
2.2 ASQ Standard:Other Standards:
3
ASQ C1 General Requirements for a Quality Program
4
ISO 9001 Quality Management Systems—Requirements
3. Terminology
3.1 The terminology descri
...
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