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ASTM F 2063 : 2018

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-01-2018

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.

1.1This 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.

1.2Requirements 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.

1.3The 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.

1.4This 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.

Committee
F 04
DocumentType
Standard
Pages
6
ProductNote
This Standard is also refer as ASTM E8/E8M-16a This Standard is also refer as ASTM E1019-18 This Standard is also refer as ASTM E 1245-03(2016) This Standard is also refer as ASTM E 1097-12(2017) This Standard is also refer as ASTM E 1447-09(2016) This Standard is also refer as ASTM E1245 - 03(2016) This Standard is also refer asASTM E1941-10(2016) This Standard is also refer as ASTM F1710 - 08(2016) This Standard is also refer as ASTM F2005 - 05(2015
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 2004 : 2017 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM F 2633 : 2013 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ASTM E 3097 : 2017 Standard Test Method for Mechanical Uniaxial Constant Force Thermal Cycling of Shape Memory Alloys
ASTM E 3098 : 2017 Standard Test Method for Mechanical Uniaxial Pre-strain and Thermal Free Recovery of Shape Memory Alloys

ASTM E 1245 : 2003 Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
ASTM E 1447 : 2001 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal Conductivity Method
ASTM E 1409 : 2013 Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
ASTM E 1941 : 2010 : R2016 Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
ASTM E 8/E8M : 2024 Standard Test Methods for Tension Testing of Metallic Materials
ASTM E 1479 : 2016 Standard Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers
ASTM E 1447 : 2022 Standard Test Method for Determination of Hydrogen in Reactive Metals and Reactive Metal Alloys by Inert Gas Fusion with Detection by Thermal Conductivity or Infrared Spectrometry
ASTM E 8/E8M : 2016 : REV A : EDT 1 Standard Test Methods for Tension Testing of Metallic Materials
ASTM E 29 : 2013 : R2019 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
ASTM E 1245 : 1995 Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
ASTM E 1941 : 2010 Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
ASTM E 1479 : 1999 : R2005 Standard Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
ASTM E 1172 : 2016 Standard Practice for Describing and Specifying a Wavelength Dispersive X-Ray Spectrometer
ASTM E 8/E8M : 2021 Standard Test Methods for Tension Testing of Metallic Materials
ASTM F 2633 : 2007 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ASTM E 1245 : 2003 : R2008 Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
ASTM E 1409 : 2004 Standard Test Method for Determination of Oxygen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique
ASTM F 2004 : 2003 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM F 1710 : 1997 Standard Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer
ASTM F 2004 : 2016 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM F 2082 : 2003 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
ASTM E 29 : 2002 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
ASTM F 2005 : 2000 Standard Terminology for Nickel-Titanium Shape Memory Alloys
ASTM E 1447 : 1992 : R1996 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal Conductivity Method
ASTM E 1409 : 2013 : R2021 Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
ASTM E 1409 : 2005 Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique
ASTM F 2633 : 2019 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ASTM E 1172 : 2022 Standard Practice for Describing and Specifying a Wavelength Dispersive X-Ray Spectrometer
ASTM E 1172 : 1987 : R2011 Standard Practice for Describing and Specifying a Wavelength-Dispersive X-Ray Spectrometer
ASTM E 1097 : 2003 Standard Guide for Direct Current Plasma Emission Spectrometry Analysis
ASTM E 1019 : 2018 Standard 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
ASTM E 1172 : 1987 : R2003 Standard Practice for Describing and Specifying a Wavelength-Dispersive X-Ray Spectrometer
ASTM E 1019 : 2003 Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel and in Iron, Nickel, and Cobalt Alloys
ASTM E 1097 : 1997 Standard Guide for Direct Current Plasma Emission Spectrometry Analysis
ASTM E 2465 : 2023 Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
ASTM F 2005 : 2005 : R2015 Standard Terminology for Nickel-Titanium Shape Memory Alloys
ASTM E 2465 : 2011 : EDT 1 Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
ASTM E 1447 : 2004 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal Conductivity Method
ASTM E 1097 : 2012 : R2017 Standard Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry
ASTM E 1019 : 2008 Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by Various Combustion and Fusion Techniques
ASTM E 8/E8M : 2022 Standard Test Methods for Tension Testing of Metallic Materials
ASTM E 1447 : 2009 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal Conductivity/Infrared Detection Method
ASTM E 2465 : 2006 Standard Test Method for Analysis of Ni-Base Alloys by X-ray Fluorescence Spectrometry
ASTM F 2004 : 2000 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM E 1479 : 1999 : R2011 Standard Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
ASTM F 2082 : 2006 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery (Withdrawn 2015)
ASTM E 1941 : 2004 Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys
ASTM E 1245 : 2000 Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
ASTM F 2004 : 2005 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM E 1172 : 1987 : R1996 Standard Practice for Describing and Specifying a Wavelength-Dispersive X-Ray Spectrometer
ASTM F 2005:2005 Standard Terminology for Nickel-Titanium Shape Memory Alloys
ASTM E 1097 : 2012 Standard Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry
ASTM F 2005 : 2005 : R2010 Standard Terminology for Nickel-Titanium Shape Memory Alloys
ASTM E 2465 : 2019 Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
ASTM E 1447 : 2009 : R2016 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal Conductivity/Infrared Detection Method
ASTM E 4 : 2021 Standard Practices for Force Calibration and Verification of Testing Machines
ASTM E 1097 : 2007 Standard Guide for Direct Current Plasma-Atomic Emission Spectrometry Analysis
ASTM F 2082 : 2001 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
ASTM F 2004 : 2005 : R2010 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM E 1409 : 1997 Standard Test Method for Determination of Oxygen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique
ASTM F 2005 : 2021 Standard Terminology for Nickel-Titanium Shape Memory Alloys
ASTM E 1409 : 2008 Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique
ASTM E 112 : 2013 : R2021 Standard Test Methods for Determining Average Grain Size
ASTM E 112 : 2013 Standard Test Methods for Determining Average Grain Size
ASTM E 1245 : 2003 : R2016 Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
ASTM F 1710 : 2008 Standard Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer
ASTM F 2082 : 2015 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
ASTM F 2633 : 2013 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ASTM E 1941 : 1998 Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys
ASTM E 1019 : 2000 Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel and in Iron, Nickel, and Cobalt Alloys
ASTM F 2004 : 2017 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM E 1172 : 1987 : R2001 Standard Practice for Describing and Specifying a Wavelength-Dispersive X-Ray Spectrometer
ASTM E 1479 : 2024 Standard Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers
ASTM E 1019 : 2002 Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel and in Iron, Nickel, and Cobalt Alloys
ASTM F 1710 : 2008 : R2016 Standard Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer (Withdrawn 2023)
ASTM E 1245 : 2003 : R2023 Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
ASTM E 1479 : 1999 Standard Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
ASTM E 1447 : 2005 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal Conductivity/Infrared Detection Method
ASTM E 1019 : 2011 Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by Various Combustion and Fusion Techniques
ASTM E 2465 : 2013 Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
ASTM E 29 : 2022 Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

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