ASTM F2989-21

Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

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STANDARD published on 1.11.2021

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The information about the standard:

Designation standards: ASTM F2989-21
Publication date standards: 1.11.2021
SKU: NS-1043848
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F2989-21 :

Keywords:

metal injection molded components, metals (for surgical implants), orthopedic medical devices, titanium alloys, titanium components (for surgical implants),, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

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 nonconformance 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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(2025)	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
E3-26	Standard Guide for Preparation of Metallographic Specimens
E8/E8M-25	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
F629-24	Standard Practice for Radiography of Cast Metallic Surgical Implants
F601-23	Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F67-24	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
E2626-25	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(2024)	Standard Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
B243-26a	Standard Terminology of Powder Metallurgy (Includes all amendments and changes 6/8/2026).
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

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