ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys

The ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants, developed by the American Society for Testing and Materials (ASTM) , describes the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium rods, flat-rolled products, and tubes containing nickel at a nominal percentage of 54,5% to 57,0% by weight, used in the manufacture of medical devices and surgical implants.

These requirements apply to milled products with diameters or thicknesses of 5,50 to 94,0 mm. Milled products are not intended to replicate the final shape, surface finish, or final properties of a medical device, implant, or component thereof. Finished nickel-titanium cold-worked tube should be evaluated under ASTM F2633.

The terminology describing the physical and thermal properties of these alloys is as defined in ASTM F2005. Additionally, for the purposes of this standard, the following definitions apply:

• Ingot refers to the amount of metal cast into a shape suitable for subsequent processing into various mill products.
• Mill product refers to any finished or semi-finished product exiting a mill. The product may be straight or coiled. Product types include hot-worked, hot-worked and cold-worked, and hot-worked and cold-worked products with or without final heat treatment.

According to this standard, product classification is as follows:

• Bar: Round and flat bars with diameter or thickness from 5,50 to 94,0 mm (other sizes or shapes by special order).
• Sheet: Any product with a thickness of 5,50 to 94,0 mm and a width equal to or greater than five times the thickness.
• Tube: Hollow cylindrical shapes with an outside diameter of 5,50 to 94,0 mm.

The material must be made from ingots of nickel and titanium with no other intentional alloying additions. The material is melted in a vacuum or inert atmosphere to control metallurgical cleanliness and alloy chemistry. The product is supplied as specified in the purchase order. The product surface condition may be oxidized, descaled, pickled, sandblasted, machined, ground, mechanically polished, or electropolished.

Bullion analysis must comply with the requirements in the table provided in the standard. Bullion analysis can be used to report all chemical requirements except hydrogen. Samples for hydrogen analysis should be taken from the finished product or as agreed upon between the customer and supplier. The supplier must not ship material outside the limits specified in the table. Requirements for major and minor elements are listed in the table. Important trace elements are also listed. Analysis for elements not listed in the table is not required to verify compliance with this standard.

Product analysis limits must be as specified in the table. Product analysis tolerances do not extend the ingot analysis specification requirements but rather address differences in chemical content measurement between laboratories. The manufacturer must not ship material outside the limits specified in the table. Product analysis is performed to verify the composition of the ingot or production batch or to identify changes in composition within the ingot. Acceptance or rejection of an ingot or production batch of material may be determined by the buyer based on this product analysis. Product analysis may be performed by a third party if agreed upon by the supplier and buyer.

Major elements are analyzed by direct current plasma spectrometry according to ASTM E1097, atomic absorption according to ASTM E1479, inductively coupled plasma spectrometry, X-ray spectrometry according to ASTM E1172, and glow discharge mass spectrometry according to ASTM F1710 or an equivalent method. Carbon is measured by combustion according to ASTM E1019 or ASTM E1941 test methods, or by wavelength-dispersive X-ray fluorescence spectrometry according to ASTM E2465 test method. Hydrogen is measured by inert gas fusion or vacuum hot extraction. Hydrogen is measured by inert gas fusion or vacuum hot extraction according to ASTM E1447 test method. Nitrogen and oxygen are measured by inert gas fusion according to ASTM E1409 test method.

Nickel-titanium shape memory alloys, used in medical devices and surgical implants, are essential for the following reasons:

• Material quality and consistency: Nickel-titanium exhibits unique properties such as shape memory and superelasticity, which are critical in medical applications. This standard allows manufacturers to produce nickel-titanium with consistent chemical composition, mechanical properties, and performance, reducing variability that can compromise device function.
• Patient safety: Devices such as stents, guide wires, and orthodontic wires rely on nickel-titanium's performance within the human body. This standard sets strict limits on impurities and inclusions to prevent malfunctions, fractures, or adverse biological reactions.
• Mechanical property verification: Outlines the test methods for tensile strength, elongation, transformation temperature, and fatigue properties necessary to verify the material's behavior under stress. This ensures that the material performs reliably under physiological conditions.
• Regulatory compliance: International regulatory bodies reference ASTM F2063 as part of their approval processes for medical devices. It helps streamline device submissions by providing a recognized benchmark for material qualification.
• Industry standardization: With its widespread use of nickel-titanium, the ASTM F2063 standard provides a common language and specification for manufacturers, suppliers, and regulatory agencies. This promotes interoperability and collaboration within the medical device industry.

In short, this standard supports innovation in device design by providing a robust framework for material performance.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, boasts a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.