ASTM F2063-18

Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

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STANDARD published on 1.8.2018

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The information about the standard:

Designation standards: ASTM F2063-18
Publication date standards: 1.8.2018
SKU: NS-857750
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Surgical instruments and materials

Annotation of standard text ASTM F2063-18 :

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.

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 Number Code 11.040.30 (Surgical instruments and materials)

Additional information

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
E1019-18	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

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