Standard Specification for Titanium 6 Al-4V ELI Alloy Surgical Implant Applications
|Publication Date:||30 March 1979|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This specification covers the chemical, mechanical, and metallurgical requirements for annealed Ti-6AI-4V ELI (extra-low interstitial) titanium alloy to be used in the manufacture of surgical implants.
This material has been subjected to testing in laboratory animals.2,3 The results of these studies and the clinical history indicate a well-characterized biological response of an acceptable level. 4,5
NOTE - The values stated in inch-pound units are to be regarded as the standard.
2 Laing, p, G., Ferguson, A. B., Jr., and Hodge, E, S., "Tissue Reaction in Rabbit Muscle Exposed to Metallic Implants." Journal of Biomedical Materials Research, Vol I, 1967, pp, 135-149.
3 Laing. P. G., "Compatibility of Biomaterials," Orthopedic Clinics of North America, Vol 4, No.2, April 1973, pp. 249-273.
4 Street, D, M., and Stevens, P. S., "A Humeral Replacement Prosthesis for the Elbow," Journal of Bone and Joint Surgry. Vol 56A, No.6, September 1974.
5 Lynch. J, .A., "Replacement Arthroplasty of the Elbow with Coonrad Total Elbow Prosthesis," Orthopaedic Digest, January 1976.