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ASTM F2989-13

(Specification)

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

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

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.

General Information

Status
Historical
Publication Date
31-Mar-2013
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.12 - Metallurgical Materials
Current Stage
Ref Project

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2989 −13
Standard Specification for
Metal Injection Molded Unalloyed Titanium Components for
1
Surgical Implant Applications
This standard is issued under the fixed designation F2989; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E165Practice for Liquid Penetrant Examination for General
Industry
1.1 This specification covers the chemical, mechanical, and
E407Practice for Microetching Metals and Alloys
metallurgical requirements for three grades of metal injection
E539TestMethodforAnalysisofTitaniumAlloysbyX-Ray
molded (MIM) unalloyed titanium components in two types to
Fluorescence Spectrometry
be used in the manufacture of surgical implants.
E1409TestMethodforDeterminationofOxygenandNitro-
1.2 The Type 1 MIM components covered by this specifi-
gen in Titanium and Titanium Alloys by the Inert Gas
cation may have been densified beyond their as-sintered
Fusion Technique
density by post-sinter processing.
E1447Test Method for Determination of Hydrogen in Tita-
nium and Titanium Alloys by Inert Gas Fusion Thermal
1.3 Values in either inch-pound or SI are to be regarded
separately as standard. The values stated in each system may Conductivity/Infrared Detection Method
E1941Test Method for Determination of Carbon in Refrac-
not be exact equivalents; therefore each system shall be used
independent of the other. Combining values from the two toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
systems may result in non-conformance with the specification.
E2371Test Method for Analysis of Titanium and Titanium
1.4 This standard does not purport to address all of the
Alloys by Atomic Emission Plasma Spectrometry (With-
safety concerns, if any, associated with its use. It is the
3
drawn 2013)
responsibility of the user of this standard to establish appro-
E2626Guide for Spectrometric Analysis of Reactive and
priate safety and health practices and determine the applica-
Refractory Metals
bility of regulatory limitations prior to use.
F67Specification for Unalloyed Titanium, for Surgical Im-
plant Applications (UNS R50250, UNS R50400, UNS
2. Referenced Documents
R50550, UNS R50700)
2
2.1 ASTM Standards:
F601Practice for Fluorescent Penetrant Inspection of Me-
B243Terminology of Powder Metallurgy
tallic Surgical Implants
B311Test Method for Density of Powder Metallurgy (PM)
F629Practice for Radiography of Cast Metallic Surgical
Materials Containing Less Than Two Percent Porosity
Implants
B923Test Method for Metal Powder Skeletal Density by
SI 10American National Standard for Use of the Interna-
Helium or Nitrogen Pycnometry
tional System of Units (SI): The Modern Metric System
E3Guide for Preparation of Metallographic Specimens 4
2.2 ISO Standards:
E8/E8MTest Methods for Tension Testing of Metallic Ma-
ISO5832-3ImplantsforSurgery—MetallicMaterials—Part
terials
3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy
E29Practice for Using Significant Digits in Test Data to
ISO 6892Metallic Materials—Tensile Testing at Ambient
Determine Conformance with Specifications
Temperature
ISO 9001Quality Management Systems—Requirements
5
2.3 Aerospace Material Specifications:
1
This specification is under the jurisdiction of ASTM Committee F04 on
AMS 2249Chemical Check Analysis Limits, Titanium and
Medical and Surgical Materials and Devices and is the direct responsibility of
Titanium Alloys
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved April 1, 2013. Published April 2013. Originally
3
approved in 2012. Last previous edition approved in 2012 as F2989–12. DOI: The last approved version of this historical standard is referenced on
10.1520/F2989-13. www.astm.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Standards volume information, refer to the standard’s Document Summary page on AvailablefromSAEInternational(SAE),400CommonwealthDr.,Warrendale,
the ASTM website. PA 15096-0001, http://aerospace.sae.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2989−13
6
2.4 MPIF Standards: 3.3.9 pre-alloyed powder, n—powder composed of two or
Standard 10Determination of the Tensile Properties of more elements that are alloyed in the powder manufacturing
Powder Metallurgy Materials process in which the particles are of the same nominal
Standar
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2989 − 12 F2989 − 13
Standard Specification for
Metal Injection Molded Unalloyed Titanium Components for
1
Surgical Implant Applications
This standard is issued under the fixed designation F2989; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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
2
2.1 ASTM Standards:
B243 Terminology of Powder Metallurgy
B311 Test Method for Density of Powder Metallurgy (PM) Materials Containing Less Than Two Percent Porosity
B923 Test Method for Metal Powder Skeletal Density by Helium or Nitrogen Pycnometry
E3 Guide for Preparation of Metallographic Specimens
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E165 Practice for Liquid Penetrant Examination for General Industry
E407 Practice for Microetching Metals and Alloys
E539 Test Method for Analysis of Titanium Alloys by X-Ray Fluorescence Spectrometry
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion
Technique
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
3
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry (Withdrawn 2013)
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)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F629 Practice for Radiography of Cast Metallic Surgical Implants
SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2012April 1, 2013. Published January 2013April 2013. Originally approved in 2012. Last previous edition approved in 2012 as
F2989– 12. DOI: 10.1520/F2989-12.10.1520/F2989-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2989 − 13
4
2.2 ISO Standards:
ISO 5832-3 Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy
ISO 6892 Metallic Materials—Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
5
2.3 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
6
2.4 MPIF Standards:
Standard 10 Determination of the Tensile Properties of Powder Metallurgy Materials
Standard 42 Determination of Density of Compact
...

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5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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.

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