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ASTM F2886-17(2023)

(Specification)

Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

ABSTRACT
This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants  
1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Units—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 nonconformance with the standard.  
1.4 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-Aug-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
Refers
ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Effective Date
01-Mar-2020

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ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant ApplicationsASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
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ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum 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: F2886 − 17 (Reapproved 2023)
Standard Specification for
Metal Injection Molded Cobalt-28Chromium-6Molybdenum
1
Components for Surgical Implant Applications
This standard is issued under the fixed designation F2886; 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 E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 This specification covers chemical, mechanical, and
E165/E165M Practice for Liquid Penetrant Testing for Gen-
metallurgical requirements for metal injection molded (MIM)
eral Industry
cobalt-28chromium-6molybdenum components to be used in
E354 Test Methods for Chemical Analysis of High-
the manufacture of surgical implants
Temperature, Electrical, Magnetic, and Other Similar Iron,
1.2 The MIM components covered by this specification may
Nickel, and Cobalt Alloys
have been densified beyond their as-sintered density by post-
E407 Practice for Microetching Metals and Alloys
sinter processing.
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
1.3 Units—The values stated in either SI units or inch-
pound units are to be regarded separately as standard. The (UNS R30075)
F601 Practice for Fluorescent Penetrant Inspection of Me-
values stated in each system may not be exact equivalents;
therefore, each system shall be used independently of the other. tallic Surgical Implants
F629 Practice for Radiography of Cast Metallic Surgical
Combining values from the two systems may result in noncon-
formance with the standard. Implants
F1537 Specification for Wrought Cobalt-28Chromium-
1.4 This international standard was developed in accor-
6Molybdenum Alloys for Surgical Implants (UNS
dance with internationally recognized principles on standard-
R31537, UNS R31538, and UNS R31539)
ization established in the Decision on Principles for the
IEEE/ASTM SI 10 American National Standard for Use of
Development of International Standards, Guides and Recom-
the International System of Units (SI): The Modern Metric
mendations issued by the World Trade Organization Technical
System
Barriers to Trade (TBT) Committee.
3
2.2 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient
2. Referenced Documents
Temperature
2
2.1 ASTM Standards:
ISO 9001 Quality Management Systems—Requirements
B243 Terminology of Powder Metallurgy
4
2.3 AMS Standards:
B311 Test Method for Density of Powder Metallurgy (PM)
AMS 2269 Chemical Check Analysis Limits, Nickel, Nickel
Materials Containing Less Than Two Percent Porosity
Alloys and Cobalt Alloys
B923 Test Method for Metal Powder Skeletal Density by
AMS 2248 Chemical Check Analysis Limits, Corrosion and
Helium or Nitrogen Pycnometry
Heat Resistant Steels and Alloys, Maraging and Other
E3 Guide for Preparation of Metallographic Specimens
Highly-Alloyed Steels, and Iron Alloys
E8/E8M Test Methods for Tension Testing of Metallic Ma-
5
2.4 MPIF Standards:
terials
MPIF Standard 10 Determination of the Tensile Properties of
Powder Metallurgy Materials
MPIF Standard 42 Determination of Density of Compacted
1
This specification is under the jurisdiction of ASTM Committee F04 on
or Sintered Powder Metallurgy Products
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Sept. 1, 2023. Published September 2023. Originally
3
approved in 2010. Last previous edition approved in 2017 as F2886 – 17. DOI Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2886-17R23. 4th Floor, New York, NY 10036, http://www.ansi.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from Metal Powder Industries Federation (MPIF), 105 College Road
the ASTM website. East, Princeton, New Jersey 08540, http://www.mpif.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2886 − 17 (2023)
MPIF Standard 50 Preparing and Evaluating Metal Injection 4.1.2 ASTM specification and date of
...

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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.  
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4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.
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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.
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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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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.  
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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.  
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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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1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
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1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
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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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Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

ABSTRACT
This specification covers the requirements for unfinished cobalt-28chromium-6molybdenum (UNS R30075) investment product alloy castings for surgical implant applications, and casting alloys of the same in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings. Both product castings and casting alloys shall conform to specified chemical composition and mechanical requirements including ultimate tensile strength, yield strength, elongation, and reduction of area. Product castings shall additional undergo liquid penetrant, radiographic, metallographic, and hardness examination.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for cobalt-28 chromium-6 molybdenum alloy unfinished investment product castings for surgical implant applications and casting alloy in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings.  
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 nonconformance with the standard.  
1.3 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.  
1.4 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.

  • Technical specification
    5 pages
    English language
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  • Technical specification
    5 pages
    English language
    sale 15% off