Abstract

This specification covers the chemical, mechanical, and dimensional requirements for wrought seamless nickel-titanium shape memory alloy tubes used for the manufacture of medical devices and surgical implants. Tubes shall be furnished in the superelastic condition, and the outer surface shall have a pickled, ground, or mechanically polished finish, or as agreed upon between purchaser and supplier. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms. This specification applies precisely to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness. The mechanical properties to which the tubes shall conform are ultimate tensile strength (UTS), uniform elongation, upper plateau strength, lower plateau strength, and residual elongation.

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 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

A632 Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General Service

F2004 Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

F2005 Terminology for Nickel-Titanium Shape Memory Alloys

F2063 Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

F2082 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

F2516 Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

ISO Standard

American Society for Quality Standards

Keywords

medical devices; metals (for surgical implant); nickel-titanium alloys; niti; nitinol; shape memory alloy; stents; superelastic alloys; surgical implants; tube;

ICS Code

ICS Number Code 77.150.40 (Nickel and chromium products)

DOI: 10.1520/F2633-07

ASTM International is a member of CrossRef.

ASTM F2633