ASTM F2886-17

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 non-conformance 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: Historical
• Publication Date: 31-Aug-2017
• 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

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F2886 − 17
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 Practice for Liquid Penetrant Examination for General
metallurgical requirements for metal injection molded (MIM)
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
1.3 Units—The values stated in either SI units or inch- Alloy Castings and Casting Alloy for Surgical Implants
(UNS R30075)
pound units are to be regarded separately as standard. The
values stated in each system may not be exact equivalents; F601 Practice for Fluorescent Penetrant Inspection of Me-
tallic Surgical Implants
therefore, each system shall be used independently of the other.
Combining values from the two systems may result in non- F629 Practice for Radiography of Cast Metallic Surgical
Implants
conformance with the standard.
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, 2017. Published October 2017. Originally
3
approved in 2010. Last previous edition approved in 2010 as F2886 – 10. DOI Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2886-17. 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 [e-mail]. 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.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2886 − 17
MPIF Standard 50 Preparing and Evaluating Metal Injection 4.1.4 Units to be certified—SI or inch-pound,
Molded Sintered/Heat Treated Tension Specimens 4.1.5 Component configuration (engineering drawing
MPIF S
...

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: F2886 − 10 F2886 − 17
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 Scope*
1.1 This specification covers the 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 non-conformance 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.
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
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
E407 Practice for Microetching Metals and Alloys
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F629 Practice for Radiography of Cast Metallic Surgical Implants
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
3
2.2 ISO Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
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, 2010Sept. 1, 2017. Published January 2011October 2017. Originally approved in 2010. Last previous edition approved in 2010 as
F2886 – 10. DOI 10.1520/F2886–10.10.1520/F2886-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2886 − 17
4
2.3 AMS Standards:
AMS 2269 Chemical Check Analysis Limits, Nickel, Nickel Alloys and Cobalt Alloys
AMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys
5
2.4 MPIF Standards:
MPIF Standard 10 Determination of the Tensile Properties of Powder Metallurgy Materials
MPIF Standard 42 Determination of Density of Compacted or Sintered Powder Metallurgy Products
MPIF Standard 50 Preparing and Evaluating Metal Injection Molded Sintered/Heat Treated Tension Specimens
MPIF Standard 63 Density Determination
...