ASTM F688-19
(Specification)Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
ABSTRACT
This specification covers the requirements for wrought cobalt-35nickel-20chromium-10molybdenum alloy for use in the manufacture of surgical implants. The alloy shall be manufactured into plates, sheets, and foils in the annealed, cold-worked, or cold-worked and capability-aged condition. The plates may be available in ground or dull finish, while the sheet and foil may be of dull cold-rolled, bright cold-rolled, intermediate polished, general-purpose polished, dull satin finished, high luster finish, or mirror finish. In addition, plate edges may be of rolled edge or approximate square edge, while for sheet and foil, edges may be approximate square edge or an edge produced by slitting or shearing. Heat and product analyses as well as tests for ultimate tensile strength, yield strength, elongation, hardness, and average grain size shall be performed and shall conform to the requirements specified.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of plate, sheet, and foil to be used in the manufacture of surgical implants.
1.2 Units—The SI units in this standard are the primary 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 this standard.
1.3 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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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:F688 −19
Standard Specification for
Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
ThisstandardisissuedunderthefixeddesignationF688;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* Hardness, Superficial Hardness, Knoop Hardness, Sclero-
scope Hardness, and Leeb Hardness
1.1 This specification covers the chemical, mechanical, and
E345 Test Methods of Tension Testing of Metallic Foil
metallurgical requirements for wrought cobalt-35nickel-
E384 Test Method for Microindentation Hardness of Mate-
20chromium-10molybdenum alloy (UNS R30035) in the form
rials
of plate, sheet, and foil to be used in the manufacture of
F562 Specification for Wrought 35Cobalt-35Nickel-
surgical implants.
20Chromium-10Molybdenum Alloy for Surgical Implant
1.2 Units—The SI units in this standard are the primary
Applications (UNS R30035)
units. The values stated in either SI units or inch-pound units
F981 Practice for Assessment of Compatibility of Biomate-
are to be regarded separately as standard. The values stated in
rials for Surgical Implants with Respect to Effect of
each system may not be exact equivalents; therefore, each
Materials on Muscle and Insertion into Bone
system shall be used independently of the other. Combining
IEEE/ASTM SI 10 American National Standard for Use of
values from the two systems may result in non-conformance
theInternationalSystemofUnits(SI):TheModernMetric
with this standard.
System
1.3 This international standard was developed in accor-
2.2 ISO Standards:
3
dance with internationally recognized principles on standard-
ISO 9001 Quality Management Systems—Requirements
ization established in the Decision on Principles for the
3. Terminology
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
3.1 Definitions of Terms Specific to This Standard:
Barriers to Trade (TBT) Committee.
3.1.1 capability—the ability of cold-worked material to
attain specific mechanical properties after thermal aging treat-
2. Referenced Documents
ment.
2
2.1 ASTM Standards:
3.1.2 foil—material under 0.13 mm [0.005 in.] in thickness.
E8/E8M Test Methods for Tension Testing of Metallic Ma-
3.1.3 lot—the total number of mill products produced from
terials
the same melt heat under the same conditions at essentially the
E10 Test Method for Brinell Hardness of Metallic Materials
same time.
E18 Test Methods for Rockwell Hardness of Metallic Ma-
3.1.4 plate—as used in this specification, material 4.75 mm
terials
[0.1875 in.] and over in thickness.
E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
3.1.5 sheet—as used in this specification, material 0.13 mm
E112 Test Methods for Determining Average Grain Size
[0.005 in.] to under 4.75 mm [0.1875 in.] in thickness.
E140 Hardness Conversion Tables for Metals Relationship
4. Ordering Information
Among Brinell Hardness, Vickers Hardness, Rockwell
4.1 Inquiries and orders for material under this specification
shall include the following information:
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.1 Quantity (weight or number of pieces);
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. 4.1.2 ASTM Designation, alloy number, and date of issue;
Current edition approved Feb. 1, 2019. Published February 2019. Originally
4.1.3 Units to be used for certification—SI or inch-pound;
approved in 1980. Last previous edition approved in 2014 as F688 – 14. DOI:
4.1.4 Form (plate, sheet, foil);
10.1520/F0688-19.
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 Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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 ----------------------
F688−19
4.1.5 Condition (see 5.1); 7.1.4 Productformsintheannealedconditionshallmeetthe
4.1.6 Mechanical properties (if applicable for special con- mechanical
...
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: F688 − 14 F688 − 19
Standard Specification for
Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
This standard is issued under the fixed designation F688; 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 wrought cobalt-35nickel-
20chromium-10molybdenum alloy (UNS R30035) in the form of plate, sheet, and foil to be used in the manufacture of surgical
implants.
1.2 Units—The SI units in this standard are the primary 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 this standard.
1.3 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:
E8/E8M Test Methods for Tension Testing of Metallic Materials
E10 Test Method for Brinell Hardness 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
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
E345 Test Methods of Tension Testing of Metallic Foil
E384 Test Method for Microindentation Hardness of Materials
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
2.2 ISO Standards:
3
ISO 9001 Quality Management Systems—Requirements
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 capability—the ability of cold-worked material to attain specific mechanical properties after thermal aging treatment.
3.1.2 foil—material under 0.13 mm [0.005 in.] in thickness.
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 Oct. 1, 2014Feb. 1, 2019. Published November 2014February 2019. Originally approved in 1980. Last previous edition approved in 20102014
as F688 – 10.F688 – 14. DOI: 10.1520/F0688-14.10.1520/F0688-19.
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
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 ----------------------
F688 − 19
3.1.3 lot—the total number of mill products produced from the same melt heat under the same conditions at essentially the same
time.
3.1.4 plate—as used in this specification, material 4.75 mm [0.1875 in.] and over in thickness.
3.1.5 sheet—as used in this specification, material 0.13 mm [0.005 in.] to under 4.75 mm [0.1875 in.] in thickness.
4. Ordering Information
4.1 Inquiries and orders for material under this specification shall include the following information:
4.1.1 Quantity (weight or number of pieces);
4.1.2 ASTM Designation, alloy number, and date of issue;
4.1.3 Units to be used for certificati
...
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