What Is The Current Status Of Medical Titanium Alloy Standardization At Home And Abroad? - News

Regarding titanium and titanium alloys for medical implants, domestic and international standards have slightly different requirements, including chemical composition and mechanical properties.

1) ISO international standards

ISO is a specialized committee for surgical implants in the International Organization for Standardization.

The number of surgical implants - metallic materials - 1~13 titanium alloys was originally 4, but now it is 3.

(1) ISO5832-2-1999 pure titanium;

(2) ISO5832-3-1996 Ti-6Al-4V processed materials;

(3) ISO5832-11-1994 Ti-6Al-7Nb processed materials; their chemical composition and mechanical properties;

ISO5832-10-1993 is the standard for Ti-5Al-2.5Fe alloy, a medical titanium alloy developed in Germany more than 20 years ago and also used in clinical practice. The International Organization for Standardization TC150 promulgated this number in September 1993 and revoked it in 2000.

2) American Standards

ASTM has been issuing standards for titanium for surgical implants since the late 1960s. With the development and application of medical titanium alloys, new medical titanium alloys have been continuously issued.

(1) Pure titanium grades 1 to 4

ASTM F67-2000 Sheet, plate, rod, strip, wire;

ASTM F1341-1999 Wire

(2) Ti-6Al-4VELI

ASTM F136-2002a Sheet, strip, rod;

ASTM F620-2002 Forgings;

ASTM F1108-2002 Castings;

ASTM F1472-2002a Sheet, plate, rod, strip, wire.

3) Ti-6Al-7Nb

ASTMF1295-2001 Rod

(4) Ti-13Nb-1.3Zr

ASTM F1713-1996 Sheet, Plate, Rod, Strip, Wire

(5) Ti-12Mo-6Zr-2Fe

ASTMF1813-2001 Rod, Wire

(6) ASTM F2063-2000 Shape Memory Alloy Processing Materials for Medical Devices and Surgical Implants

3) Chinese Standards (GB/T13810-2007 and GB/T12417-1990)

(1) GB/T13810-2007：Titanium and titanium alloys for surgical implants

National Standard The grades include pure titanium (4 grades) and Ti-6Al-4V alloy.

Various types include thin plates, thick plates, strips, bars and wires. This standard is equivalent to the international standard (ISO5832.2.3) and the American standard (ASTMF67 and ASTMF136). The chemical composition and mechanical properties are equivalent to the above standards. The microstructure (Gr5 titanium alloy metallographic structure classification and rating diagram) adopts the international ISO ETTC2 A1-A9. The inspection method standard adopts the method specified in the national standard.

2) GB/12417-1990 "General Technical Requirements for Surgical Metal Implants"

This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthotics and was drafted by the Tianjin Institute of Medical Devices. This standard references international standards ISO 5832, "Surgical Metal Implants - Metallic Materials,"

Part 1: Wrought Stainless Steel (1987);

Part 2: Titanium;

Part 3: Ti-6Al-4V Processed Materials;

Part 4: Titanium-Chromium-Molybdenum Cast Alloys." The marking and packaging requirements are equivalent to those of international standard ISO 6018, "General Requirements for Marking, Packaging, and Labeling of Orthopedic Implants."

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