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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.
Significance and Use
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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 StandardISO13485 Quality Management Standard for Medical Devices ISO 9001 Quality Management Systems--Requirements
ICS Number Code 77.150.40 (Nickel and chromium products)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)