ASTM F1058-16
(Specification)Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
ABSTRACT
This specification covers the requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel- 7molybdenum alloy in the form of wire and strip used for the manufacture of surgical implants. The heat analysis shall conform to the prescribed chemical composition requirements of grade 1 or 2. The tensile strength, hardness, yield strength, elongation, and microstructure shall be tested to meet the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel-7molybdenum alloy in the form of wire, strip and bar used for the manufacture of surgical implants.
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 non-conformance with the standard.
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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:F1058 −16
Standard Specification for
Wrought 40Cobalt-20Chromium-16Iron-15Nickel-
7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical
1
Implant Applications (UNS R30003 and UNS R30008)
This standard is issued under the fixed designation F1058; 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* scope Hardness, and Leeb Hardness
E354 Test Methods for Chemical Analysis of High-
1.1 This specification covers the chemical, mechanical, and
Temperature,Electrical,Magnetic,andOtherSimilarIron,
metallurgical requirements for two grades of wrought
Nickel, and Cobalt Alloys
40cobalt-20chromium-16iron-15nickel-7molybdenum alloy in
IEEE/ASTM SI 10American National Standard for Metric
the form of wire, strip and bar used for the manufacture of
Practice
surgical implants.
3
2.2 Aerospace Material Specifications:
1.2 The values stated in either SI units or inch-pound units
AMS 2269 Chemical Check Analysis Limits Wrought
are to be regarded separately as standard. The values stated in
Nickel and Alloys and Cobalt Alloys
each system may not be exact equivalents; therefore, each
AMS 5833Alloy Wire, Corrosion and Heat Resistant 20Cr-
system shall be used independently of the other. Combining
15Ni-40Co-7.0Mo-16Fe Solution Treated and Cold
values from the two systems may result in non-conformance
Drawn
with the standard.
AMS 5834Alloy Wire, Corrosion and Heat Resistant 20Cr-
15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, Cold
2. Referenced Documents
Drawn, and Aged
2
2.1 ASTM Standards:
AMS 5875Alloy Strip, Corrosion and Heat Resistant 20Cr-
A751Test Methods, Practices, and Terminology for Chemi-
15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, Cold
cal Analysis of Steel Products
Rolled, and Aged
E8/E8MTest Methods for Tension Testing of Metallic Ma-
AMS 5876Alloy Strip, Corrosion and Heat Resistant 20Cr-
terials
15Ni-40Co-7.0Mo-16Fe Solution Heat Treated and Cold
E18Test Methods for Rockwell Hardness of Metallic Ma-
Rolled
terials
4
2.3 ISO Standards:
E29Practice for Using Significant Digits in Test Data to
ISO5832-7ImplantsforSurgery—MetallicMaterials—Part
Determine Conformance with Specifications
7 Forgeable and Cold Formed Co-Cr-Ni-Mo-Fe Alloy
E45Test Methods for Determining the Inclusion Content of
ISO 6892–1Metallic materials—Tensile testing—Part 1:
Steel
Method of test at room temperature
E92Test Methods for Vickers Hardness and Knoop Hard-
ISO 9001Quality Management Systems—Requirements
ness of Metallic Materials
5
E112Test Methods for Determining Average Grain Size
2.4 Society of Automotive Engineers:
E140Hardness Conversion Tables for Metals Relationship
SAE J1086Practice for Numbering Metals and Alloys
Among Brinell Hardness, Vickers Hardness, Rockwell
(UNS)
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
3. Terminology
1 3.1 Definitions of Terms Specific to This Standard:
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 Nov. 1, 2016. Published January 2017. Originally
3
approved in 1991. Last previous edition approved in 2008 as F1058–08. DOI: Available from Society of Automotive Engineers (SAE), 400 Commonwealth
10.1520/F1058-16. Dr., Warrendale, PA 15096-0001, http://www.sae.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, http://www.sae.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 ----------------------
F1058−16
TABLE 1 Chemical Requirements, Heat Analysis
3.1.1 bar, n—round bars and flats from 4.75 to 101.60 mm
[0.1875 to 4.00 in.] in diameter or thickness (other shapes by Composition, (% mass/mass)
special order). Element Grade 1 (UNS R30003) Grade 2 (UNS R30008)
min max min max
3.1.2 fine wire, n—wire as described in 3.1.5, less than 1.60
Carbon . 0.15 . 0.15
mm [0.063 in.] in diameter o
...
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: F1058 − 08 F1058 − 16
Standard Specification for
Wrought 40Cobalt-20Chromium-16Iron-15Nickel-
7Molybdenum Alloy Wire Wire, Strip, and Strip Bar for
Surgical Implant Applications (UNS R30003 and UNS
1
R30008)
This standard is issued under the fixed designation F1058; 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 two grades of wrought 40cobalt-
20chromium-16iron-15nickel-7molybdenum alloy in the form of wire wire, strip and stripbar used for the manufacture of surgical
implants.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The inch-pound equivalents
of the SI units in parentheses are for information only.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.
2. Referenced Documents
2
2.1 ASTM Standards:
A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
E8E8/E8M Test Methods for Tension Testing of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E45 Test Methods for Determining the Inclusion Content of Steel
E92 Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E112 Test Methods for Determining Average Grain Size
E140 Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness,
Superficial Hardness, Knoop Hardness, Scleroscope Hardness, and Leeb Hardness
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
IEEE/ASTM SI 10 American National Standard for Metric Practice
3
2.2 Aerospace Material Specifications:
AMS 2269 Chemical Check Analysis Limits Wrought Nickel and Alloys and Cobalt Alloys
AMS 5833 Alloy Wire, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Treated and Cold Drawn
AMS 5834 Alloy Wire, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, Cold Drawn, and
Aged
AMS 5875 Alloy Strip, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, Cold Rolled, and
Aged
AMS 5876 Alloy Strip, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated and Cold Rolled
2.3 American Society for Quality Standards:
4
ASQ C1 Specification of General Requirements for a Quality Program
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 May 1, 2008Nov. 1, 2016. Published June 2008January 2017. Originally approved in 1991. Last previous edition approved in 20022008 as
F1058 – 02.F1058 – 08. DOI: 10.1520/F1058-08.10.1520/F1058-16.
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’sstandard’s Document Summary page on the ASTM website.
3
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.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 ----------------------
F1058 − 16
4
2.3 ISO Standards:
ISO 5832-7 Implants for Surgery—Metallic Materials—Part 7 Forgeable and Cold Formed Co-Cr-Ni-Mo-Fe Alloy
ISO 68926892–1 Metallic Materials—Tensile Testingmaterials—Tensile testing—Part 1: Method of test at room temperature
ISO 9001 Quality Management Systems—Requirements
5
2.4 Society of Automotive Engineers:
SAE J1086 Practice for Numbering Metals and Alloys (UNS)
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bar, n—round bars and flats from 4.75 to 101.60 mm [0.1875 to 4.00 in.] in diameter or thickness (other shapes by special
order).
3.1.2 fine wire, n—wire as
...
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