ASTM F2063-18 - 1.8.2018
 
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

ISO 9001

Quality Management Systems--Requirements Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.

IEEE/ASTM SI 10

American National Standard for Metric Practice

E1019-24

Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by Combustion and Inert Gas Fusion Techniques

E1097-25

Standard Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry

E1172-22

Standard Practice for Describing and Specifying a Wavelength Dispersive X-Ray Spectrometer

E1245-03(2023)

Standard Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis

E1409-13(2021)

Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion

E1447-22

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

E1479-24

Standard Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers

E1941-10(2024)

Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis

F2004-24

Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

F2005-21(2025)

Standard Terminology for Nickel-Titanium Shape Memory Alloys

F2633-19

Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

E4-24

Standard Practices for Force Calibration and Verification of Testing Machines

E8/E8M-25

Standard Test Methods for Tension Testing of Metallic Materials

E29-22

Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

F1710-08

Standard Test Method for Trace Metallic Impurities in Electronic Grade Titanium by High Mass-Resolution Glow Discharge Mass Spectrometer

E112-25

Standard Test Methods for Determining Average Grain Size