ASTM F2989-12 - 1.12.2012
 
1. Scope

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants.

1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.

1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore each system shall be used independent of the other. Combining values from the two systems may result in non-conformance with the specification.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

 
2. Referenced Documents

Standard 50

Preparing and Evaluating Metal Injection Molded Sintered/Heat Treated Tension Specimens

Standard 63

Density Determinations of MIM Components (Gas Pycnometry)

Standard 64

Terms Used in Metal Injection Molding

ISO 6892

Metallic Materials--Tensile Testing at Ambient Temperature

ISO 9001

Quality Management Systems--Requirements

AMS 2249

Chemical Check Analysis Limits, Titanium and Titanium Alloys

Standard 10

Determination of the Tensile Properties of Powder Metallurgy Materials

E539-19

Standard Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry

B311-22

Standard Test Method for Density of Powder Metallurgy (PM) Materials Containing Less Than Two Percent Porosity

B923-23

Standard Test Method for Metal Powder Skeletal Density by Helium or Nitrogen Pycnometry

E3-11(2017)

Standard Guide for Preparation of Metallographic Specimens

E8/E8M-24

Standard Test Methods for Tension Testing of Metallic Materials

E29-22

Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

E165-09

Standard Practice for Liquid Penetrant Examination for General Industry

E407-23

Standard Practice for Microetching Metals and Alloys

Standard 42

Determination of Density of Compacted or Sintered Powder Metallurgy Product

ISO 5832-3

Implants for Surgery--Metallic Materials--Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy

SI 10

American National Standard for Use of the International System of Units (SI): The Modern Metric System

F629-20

Standard Practice for Radiography of Cast Metallic Surgical Implants

F601-23

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

F67-13(2017)

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

E2626-08

Standard Guide for Spectrometric Analysis of Reactive and Refractory Metals

E2371-21a

Standard Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma Atomic Emission Spectrometry (Performance-Based Test Methodology) (Includes all amendments and changes 1/6/2022).

E1941-10(2016)

Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis

B243-23

Standard Terminology of Powder Metallurgy

E1409-13(2021)

Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion

E1447-22

Standard Test Method for Determination of Hydrogen in Reactive Metals and Reactive Metal Alloys by Inert Gas Fusion with Detection by Thermal Conductivity or Infrared Spectrometry