Abstract

This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions. The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or cold finished and annealed or heat treated. Surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished. Major elements shall be analyzed by direct current plasma spectrometry, atomic absorption, inductively coupled plasma spectrometry, X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method. Carbon shall be measured by combustion and hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured by inert gas fusion. The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method must be used to assure the alloy formulation in terms of transformation temperature. Mechanical properties of the samples such as tensile strength and elongation shall be determined after annealing.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

1. Scope

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/F2063-12

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ASTM F2063