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Normas ASTM – AENOR
ASTM F2633-07

ASTM F2633-07

Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

Fecha:
2013-11-26 /Historical
Superseeded by:
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.

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.

Keywords:
medical devices; metals (for surgical implant); nickel-titanium alloys; niti; nitinol; shape memory alloy; stents; superelastic alloys; surgical implants; tube
50,71
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