• ASTM F 2063 : 2018

    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:  01-08-2018

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Standard
    Product Note 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
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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 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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