ASTM F2384-10(2016) - 1.4.2016
 
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

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Method for Determining Hafnium in Zirconium and Zirconium Alloys By Direct Current Plasma—Atomic Emission Spectrometry (Withdrawn 2021)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)