The relevant standards for titanium foil for medical implants are mainly as follows:
Chinese Standard
GB/T 13810-2007 "Titanium and Titanium Alloy Processing Materials for Surgical Implants": This is China's national standard for titanium and titanium alloy processing materials for surgical implants, covering grades such as TA1ELI, TA1, TA2, TA3, TA4, TC4, TC4ELI, TC20, etc. In order to ensure the comprehensive performance of the material, this standard has very strict requirements and controls on the high-magnification metallographic structure and hydrogen content and other interstitial element content of the two-phase titanium alloy, and requires strict 100% ultrasonic flaw detection of plate and rod processing materials to ensure the internal quality of the product.
YY/T 1615-2018 "General Requirements for Anodic Oxide Films of Titanium and Titanium Alloys for Surgical Implants": It specifies the terms, definitions, performance requirements and test methods of the effective surface of the anodized film of titanium and titanium alloys for surgical implants. Applicable to the anodic oxide film that undergoes oxidation reaction on the surface with titanium and titanium alloy products as anodes in the corresponding electrolyte according to the principle of electrolysis through the action of an external electric field. The color and color difference, film thickness, open circuit potential, scratch resistance, hardness, cytotoxicity and other aspects of the anodic oxide film are regulated.
American Standard
ASTM F67 "Pure Titanium for Surgical Implants": specifies the chemical, mechanical and metallurgical requirements for four grades of pure titanium (UNS R50250, UNS R50400, UNS R50550, UNS R50700) used to manufacture surgical implants. The material can be hot-rolled, cold-rolled, forged, annealed or stress-relieved, and there are clear requirements for the mechanical properties of titanium materials such as ultimate tensile strength, yield strength, elongation and cross-sectional shrinkage.
ASTM F136 "6Al4V ELI Titanium Alloy for Surgical Implants": Standard specification for 6Al4V ELI titanium alloy for surgical implant applications, which specifies its chemical composition, mechanical properties, heat treatment status, etc., to ensure the safety and reliability of the material in the medical implant environment.
In addition, in actual production and application, titanium foil for medical implants must also meet biocompatibility standards, such as passing the ISO 10993 series of tests, including tests on cytotoxicity, sensitization, and genotoxicity. At the same time, in terms of corrosion resistance, it must meet relevant requirements such as a corrosion rate of <0.001mm/year in physiological saline (ASTM G31).
The relevant standards for titanium foil for medical implants are mainly as follows:
Chinese Standard
GB/T 13810-2007 "Titanium and Titanium Alloy Processing Materials for Surgical Implants": This is China's national standard for titanium and titanium alloy processing materials for surgical implants, covering grades such as TA1ELI, TA1, TA2, TA3, TA4, TC4, TC4ELI, TC20, etc. In order to ensure the comprehensive performance of the material, this standard has very strict requirements and controls on the high-magnification metallographic structure and hydrogen content and other interstitial element content of the two-phase titanium alloy, and requires strict 100% ultrasonic flaw detection of plate and rod processing materials to ensure the internal quality of the product.
YY/T 1615-2018 "General Requirements for Anodic Oxide Films of Titanium and Titanium Alloys for Surgical Implants": It specifies the terms, definitions, performance requirements and test methods of the effective surface of the anodized film of titanium and titanium alloys for surgical implants. Applicable to the anodic oxide film that undergoes oxidation reaction on the surface with titanium and titanium alloy products as anodes in the corresponding electrolyte according to the principle of electrolysis through the action of an external electric field. The color and color difference, film thickness, open circuit potential, scratch resistance, hardness, cytotoxicity and other aspects of the anodic oxide film are regulated.
American Standard
ASTM F67 "Pure Titanium for Surgical Implants": specifies the chemical, mechanical and metallurgical requirements for four grades of pure titanium (UNS R50250, UNS R50400, UNS R50550, UNS R50700) used to manufacture surgical implants. The material can be hot-rolled, cold-rolled, forged, annealed or stress-relieved, and there are clear requirements for the mechanical properties of titanium materials such as ultimate tensile strength, yield strength, elongation and cross-sectional shrinkage.
ASTM F136 "6Al4V ELI Titanium Alloy for Surgical Implants": Standard specification for 6Al4V ELI titanium alloy for surgical implant applications, which specifies its chemical composition, mechanical properties, heat treatment status, etc., to ensure the safety and reliability of the material in the medical implant environment.
In addition, in actual production and application, titanium foil for medical implants must also meet biocompatibility standards, such as passing the ISO 10993 series of tests, including tests on cytotoxicity, sensitization, and genotoxicity. At the same time, in terms of corrosion resistance, it must meet relevant requirements such as a corrosion rate of <0.001mm/year in physiological saline (ASTM G31).
