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This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-13niobium-13zirconium alloy (UNS R58130) bars and wires to be used in the manufacture of surgical implants. The mill products may be supplied as specified by the purchaser with a descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished finish. Materials shall be furnished in the unannealed, solution-treated, or capability-aged condition. The mechanical properties to which the alloys shall conform are tensile strength, yield strength, elongation, and reduction of area.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E8 Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Technique
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal Conductivity/Infrared Detection Method
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
American Society for Quality (ASQ) StandardASQC1 Specifications of General Requirements for a Quality Program Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
ISO StandardsISO5832-3 Implants for Surgery--Metallic Materials--Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org. ISO6892 Metallic Materials Tensile Testing at Ambient Temperature ISO9001 Quality Management Systems--Requirements
Aerospace Material SpecificationAMS2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 77.120.50 (Titanium and titanium alloys)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products); 12141746(Titanium Ti)