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ASTM F2885-17(2023)

(Specification)

Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for two types of metal injection molded (MIM) titanium-6aluminum-4vanadium components 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 Units—The 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.

General Information

Status
Published
Publication Date
31-Jan-2023
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

Relations

Refers
ASTM F629-20 - Standard Practice for Radiography of Cast Metallic Surgical Implants
Effective Date
01-Feb-2020

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ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant ApplicationsASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
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ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
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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.
Designation: F2885 − 17 (Reapproved 2023)
Standard Specification for
Metal Injection Molded Titanium-6Aluminum-4Vanadium
1
Components for Surgical Implant Applications
This standard is issued under the fixed designation F2885; 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 B923 Test Method for Metal Powder Skeletal Density by
Helium or Nitrogen Pycnometry
1.1 This specification covers chemical, mechanical, and
E3 Guide for Preparation of Metallographic Specimens
metallurgical requirements for two types of metal injection
E8/E8M Test Methods for Tension Testing of Metallic Ma-
molded (MIM) titanium-6aluminum-4vanadium components
terials
to be used in the manufacture of surgical implants.
E29 Practice for Using Significant Digits in Test Data to
1.2 The Type 1 MIM components covered by this specifi-
Determine Conformance with Specifications
cation may have been densified beyond their as-sintered
E165/E165M Practice for Liquid Penetrant Testing for Gen-
density by post sinter processing.
eral Industry
1.3 Units—The values in either inch-pound or SI are to be E407 Practice for Microetching Metals and Alloys
E539 Test Method for Analysis of Titanium Alloys by
regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system Wavelength Dispersive X-Ray Fluorescence Spectrometry
E1409 Test Method for Determination of Oxygen and Nitro-
shall be used independent of the other. Combining values from
the two systems may result in nonconformance with the gen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Re-
specification.
active Metals and Reactive Metal Alloys by Inert Gas
1.4 This standard does not purport to address all of the
Fusion with Detection by Thermal Conductivity or Infra-
safety concerns, if any, associated with its use. It is the
red Spectrometry
responsibility of the user of this standard to establish appro-
E1941 Test Method for Determination of Carbon in Refrac-
priate safety, health, and environmental practices and deter-
tory and Reactive Metals and Their Alloys by Combustion
mine the applicability of regulatory limitations prior to use.
Analysis
1.5 This international standard was developed in accor-
E2371 Test Method for Analysis of Titanium and Titanium
dance with internationally recognized principles on standard-
Alloys by Direct Current Plasma and Inductively Coupled
ization established in the Decision on Principles for the
Plasma Atomic Emission Spectrometry (Performance-
Development of International Standards, Guides and Recom-
Based Test Methodology)
mendations issued by the World Trade Organization Technical
E2626 Guide for Spectrometric Analysis of Reactive and
Barriers to Trade (TBT) Committee.
3
Refractory Metals (Withdrawn 2017)
F601 Practice for Fluorescent Penetrant Inspection of Me-
2. Referenced Documents
tallic Surgical Implants
2
2.1 ASTM Standards:
F629 Practice for Radiography of Cast Metallic Surgical
B243 Terminology of Powder Metallurgy
Implants
B311 Test Method for Density of Powder Metallurgy (PM)
F1108 Specification for Titanium-6Aluminum-4Vanadium
Materials Containing Less Than Two Percent Porosity
Alloy Castings for Surgical Implants (UNS R56406)
F1472 Specification for Wrought Titanium-6Aluminum-
4Vanadium Alloy for Surgical Implant Applications (UNS
1
This specification is under the jurisdiction of ASTM Committee F04 on
R56400)
Medical and Surgical Materials and Devices and is the direct responsibility of
IEEE/ASTM SI 10 American National Standard for Use of
Subcommittee F04.12 on Metallurgical Materials.
the International System of Units (SI): The Modern Metric
Current edition approved Feb. 1, 2023. Published February 2023. Originally
approved in 2011. Last previous edition approved in 2017 as F2885 – 17. DOI: System
10.1520/F2885-17R23.
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
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on www.ast-
the ASTM website. m.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2885 − 17 (2023)
4
2.2 ISO Standards: mixing meta
...

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ASTM F601-23(Practice)
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SCOPE
1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
1.2 This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high flexion motions such as squatting or kneeling.  
1.3 Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture under stated test conditions.  
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This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization. This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: mechanical capture, plasma spray deposition, dipping/sintering, electrophoretic deposition, porcelainizing, and sputtering. Substrates may include smooth, porous, textured, and other implantable topographical forms. This specification excludes organic coatings that may contain calcium and phosphate ionic species. Materials shall be tested and the individual grades shall conform to chemical requirements such as elemental analysis for calcium and phosphates, and intentional additions, trace element analysis for hydroxylapatite and beta tricalcium phosphate; crystallographic characterization such as Fourier Transform infrared spectroscopy, and environmental stability; physical characterization such as coverage of substrate, thickness, porosity, color, surface topography, and density; and mechanical characterization such as tensile bond strength, shear strength, and fatigue strength. The test specimen fabrication and contact with calcium phosphate coatings are also detailed.
SCOPE
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.  
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1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2.  
1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms.  
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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
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1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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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.  
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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.  
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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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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. 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.  
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.  
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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.

  • Guide
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  • Guide
    8 pages
    English language
    sale 15% off