1. Scope

1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, wire, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants.

1.2 The values stated in SI units are to be regarded as the standard. The values given in inch-pound units are for information only.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E4 Practices for Force Verification of Testing Machines

E8 Test Methods for Tension Testing of Metallic Materials

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 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 the Inert Gas Fusion Technique

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

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

F2082 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

ASQ Standard

Keywords

cardiac devices; metals; NiTi; TiNi; nitinol; nickel-titanium alloys; titanium-nickel alloys; orthopaedic medical devices; vascular devices; shape memory alloys; stents; superelastic alloys; surgical implants;

ICS Code

ICS Number Code 11.040.30 (Surgical instruments and materials)

DOI: 10.1520/F2063-00

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