This specification covers the requirements fro wrought zirconium-2.5niobium alloy for use in surgical implant applications. The material shall be manufactured into bars or wires by multiple vacuum melting in arc furnaces, by electron beam melting, or by other melting processes conventionally used for reactive metals. The material shall be in the annealed condition, with the surface descaled or pickled, abrasively blasted, chemically milled, ground, machined, peeled, or polished. Heat and product analyses and tests for tensile strength, yield strength, and elongation shall be performed and shall conform to the requirements specified. In addition, the material shall have a microstructure consisting of a fine dispersion of the alpha and beta phases as a result of processing in the alpha plus beta field, with no coarse, elongated alpha platelets.
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1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought zirconium-2.5niobium alloy to be used in the manufacture of surgical implants (1).
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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.
B550/B550M Specification for Zirconium and Zirconium Alloy Bar and Wire
E8/E8M 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
E1552 Test Method for Determining Hafnium in Zirconium and Zirconium Alloys By Direct Current Plasma--Atomic Emission Spectrometry
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals
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
SI10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
ISO9001 Quality Management Systems--Requirements
metals (for surgical implants); orthopaedic medical devices; zirconium alloys; zirconium alloys (for surgical implants); Surgical implants; UNS R60901; Zirconium-2.5 niobium alloy;
ICS Number Code 77.120.99 (Other non-ferrous metals and their alloys)
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Citing ASTM Standards
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