ASTM F2633-07 - 1.4.2007
 
1. Scope

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 F 2063. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F 2063.

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.

 
2. Referenced Documents

ISO?9001

Quality Management Systems--Requirements

ISO 13485

Quality Management Standard for Medical Devices

F2516-22

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

F2082-15

Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

F2063-18

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

F2005-21

Standard Terminology for Nickel-Titanium Shape Memory Alloys

F2004-17

Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

A632-19

Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General Service