1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F2063.
1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness.
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses (inch-pound units) are for information only.
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.
ASTM F2633-19 Referenced Document
ASTM A632 Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General Service
ASTM F2004 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM F2005 Standard Terminology for Nickel-Titanium Shape Memory Alloys*, 2021-03-01 Update
ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2082 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery*, 2024-04-21 Update
ASTM F2516 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials*, 2022-06-01 Update