ASTM F2384-10(2016)

Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)

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STANDARD published on 1.4.2016

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The information about the standard:

Designation standards: ASTM F2384-10(2016)
Publication date standards: 1.4.2016
SKU: NS-639553
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Other non-ferrous metals and their alloys

Annotation of standard text ASTM F2384-10(2016) :

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.

Keywords:
metals (for surgical implants), orthopaedic medical devices, zirconium alloys, zirconium alloys (for surgical implants),, ICS Number Code 77.120.99 (Other non-ferrous metals and their alloys)

Additional information

1. Scope

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 1.2 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

B550/B550M-23	Standard Specification for Zirconium and Zirconium Alloy Bar and Wire
E8/E8M-24	Standard Test Methods for Tension Testing of Metallic Materials
E2626-08	Standard Guide for Spectrometric Analysis of Reactive and Refractory Metals
E1941-10(2016)	Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
E1552-15	Standard Test Method for Determining Hafnium in Zirconium and Zirconium Alloys By Direct Current Plasma—Atomic Emission Spectrometry (Withdrawn 2021)
E112-13(2021)	Standard Test Methods for Determining Average Grain Size
E29-22	Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
ISO 9001	Quality Management Systems--Requirements
ISO 6892	Metallic Materials Tensile Testing at Ambient Temperature
SI 10	American National Standard for Use of the International System of Units (SI): The Modern Metric System
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F67-13(2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

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