This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants. The product shall be classified as: strip; sheet; plate; bar; or wire. The heat analysis shall conform to the chemical composition prescribed. Material shall be furnished in the beta annealed condition. Bend tests and tension tests shall be performed to conform to the specified requirements.
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.
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
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
E112 Test Methods for Determining Average Grain Size
E290 Test Methods for Bend Testing of Material for Ductility
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
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
F1408 Practice for Subcutaneous Screening Test for Implant Materials
Aerospace Material Specification
AMS2249 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.
ISO9001 Quality Management Systems
American Society for Quality Standard
ASQC1 Specification 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.
metals (for surgical implants); orthopaedic medical devices; titanium alloys; titanium alloys (for surgical implants); UNS R58150 (Ti-15 Mo alloy); Metallic surgical implant materials--specifications; Metals (for surgical implants)--titanium alloys; Molybdenum (surgical implants)--specifications; Orthopaedic medical devices--specifications (Ti/Ti alloy); Surgical implants--specifications; Titanium (Ti) (for surgical implants)--specifications;
ICS Number Code 11.040.30 (Surgical instruments and materials)
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