ASTM F2063-18
(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.] 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.
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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
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* 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
1
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.
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
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F2063−18
3
2.2 ISO Standard: 6.4 The product surface condition may be oxidized,
ISO 9001Quality
...
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
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 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
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
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 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.
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 − 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-Tita
...
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