ASTM-F2063 2005(Redline)
$23.40
F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants (Redline)
Published By | Publication Date | Number of Pages |
ASTM | 2005 | 6 |
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
1.1 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.
1.2 Requirements are for mill product, measuring 6 to 130 mm (0.24 to 5.12 in.) diameter or thickness, in its annealed condition.
1.3 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
C1 General Requirements for a Quality Program Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.
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/F2063-05 ASTM International is a member of CrossRef.
Citing ASTM Standards