ASTM F2063-12 - 1.12.2012
 
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.] 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.

 
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

E1019-18

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

E1097-12(2017)

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

E1479-16

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

E1941-10(2016)

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

F2004-17

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

F2005-21

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

E4-21

Standard Practices for Force Calibration and Verification of Testing Machines

E8/E8M-24

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

E112-13(2021)

Standard Test Methods for Determining Average Grain Size