ASTM F688-19

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.

General Information

• Status: Published
• Publication Date: 31-Jan-2019
• 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

Relations

• Replaces: ASTM F688-14 - Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
• Effective Date: 01-Feb-2019
• Refers: ASTM E345-24 - Standard Test Methods of Tension Testing of Metallic Foil
• Effective Date: 01-Jan-2024
• Refers: ASTM E8/E8M-24 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jan-2024
• Refers: ASTM E18-18 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2018
• Refers: ASTM E18-17 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2017
• Refers: ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 15-Jul-2016
• Refers: ASTM E345-16 - Standard Test Methods of Tension Testing of Metallic Foil
• Effective Date: 15-Jul-2016
• Refers: ASTM E8/E8M-15 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Feb-2015
• Refers: ASTM E10-14 - Standard Test Method for Brinell Hardness of Metallic Materials
• Effective Date: 01-May-2014
• Refers: ASTM E345-93(2013)e1 - Standard Test Methods of Tension Testing of Metallic Foil
• Effective Date: 01-Nov-2013
• Refers: ASTM E8/E8M-13 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jun-2013
• Refers: ASTM E18-12 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Dec-2012
• Refers: ASTM E112-12 - Standard Test Methods for Determining Average Grain Size
• Effective Date: 15-Nov-2012
• Refers: ASTM E10-12 - Standard Test Method for Brinell Hardness of Metallic Materials
• Effective Date: 01-Jan-2012
• Refers: ASTM E8/E8M-11 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Dec-2011

Overview

ASTM F688-19: Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) establishes requirements for the chemical, mechanical, and metallurgical properties of wrought cobalt-nickel-chromium-molybdenum alloy products intended for use in surgical implant manufacturing. These products, available as plate, sheet, and foil, are provided in various conditions, such as annealed, cold-worked, or cold-worked and capability-aged. The standard ensures material consistency, performance, and suitability for critical medical applications.

Key Topics

• Product Forms and Conditions

  • Covers plates (≥4.75 mm), sheets (0.13 to <4.75 mm), and foils (<0.13 mm)
  • Specifies delivery in annealed, cold-worked, or capability-aged conditions
  • Details surface finishes and edge requirements for each form

• Material Requirements

  • Chemical composition as defined in ASTM F562
  • Mechanical requirements including:
    • Ultimate tensile strength
    • Yield strength
    • Elongation
    • Hardness
    • Microstructure (grain size)

• Testing and Certification

  • Tension testing per ASTM E8/E8M (plate, sheet) and E345 (foil)
  • Hardness evaluation using Rockwell and Vickers methods
  • Grain size assessment per ASTM E112
  • Requirements for supplier certification and quality program (e.g., ISO 9001)

• Quality Assurance

  • Mandates test reports and certifications with each shipment
  • Requires adherence to selected measurement units (SI or inch-pound)
  • Specifies adherence to quality management systems

Applications

This specification ensures that wrought cobalt-35nickel-20chromium-10molybdenum alloy plate, sheet, and foil meet the stringent demands for surgical implant manufacturing. Typical applications include:

• Orthopedic implants: Plates, screws, and prosthetic components
• Cardiovascular devices: Stents and lead wires for pacemakers
• Dental implants: Customized abutments and restorative devices
• General surgical devices: Components where high strength and corrosion resistance are essential

The alloy's track record in implant applications is supported by documented long-term biocompatibility and corrosion resistance. Its mechanical properties and dimensional stability make it ideal for precisely engineered medical devices where patient safety and material consistency are critical.

Related Standards

ASTM F688-19 integrates and references multiple other standards to ensure a comprehensive approach to material specification and quality:

• ASTM F562: Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
• ASTM E8/E8M: Tension Testing of Metallic Materials
• ASTM E10, E18, E384, E140: Hardness Testing and Conversion for Metallic Materials
• ASTM E29: Significant Digits in Test Data
• ASTM E112: Grain Size Determination
• ASTM E345: Tension Testing of Metallic Foil
• ASTM F981: Assessment of Biomaterials Compatibility for Surgical Implants
• ISO 9001: Quality Management Systems Requirements
• IEEE/ASTM SI 10: Standard for the International System of Units (SI)

For manufacturers, engineers, and procurement specialists working with surgical implants, ASTM F688-19 offers a detailed, internationally recognized framework to ensure regulatory compliance and high performance of finished medical devices.

Keywords: ASTM F688, cobalt alloy for surgical implants, UNS R30035, cobalt-nickel-chromium-molybdenum alloy, implant materials specification, surgical implant standards, biomedical alloy plate sheet foil, orthopedic implant alloy, biocompatibility.

Standards Content (Sample)

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
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:
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.
2.1 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:
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.
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 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
F688−19
4.1.5 Condition (see 5.1); 7.1.4 Productformsintheannealedconditionshallmeetthe
4.1.6 Mechanical properties (if applicable for special con- mechanical property requirements specified in Table 1.
ditions); 7.1.5 Sheetproductinthe48 %cold-workedconditionshall
4.1.7 Finish (see 5.2 and 5.3); meet the mechanical property requirements specified in Table
4.1.8 Edge (see 5.4 and 5.5); 1. Other product forms and cold-worked conditions shall meet
4.1.9 Applicable dimensions, including size, thickness, the mechanical property requirements as agreed upon between
width, and length (exact, random, or multiples) or print the supplier and purchaser.
number; 7.1.6 Product forms in the cold-worked and capability-aged
4.1.10 Special tests (if any); and condition shall meet the mechanical property requirements as
4.1.11 Other requirements. agreed upon between the supplier and purchaser.
7.2 Hardness:
5. Manufacture
7.2.1 When desired, Rockwell hardness B scale (HRB),
5.1 Condition—Plate, sheet, and foil shall be furnished as
Rockwell hardness C scale (HRC), or Vickers hardness (HV)
specified in the annealed, cold-worked, or cold-worked and
limits may be specified, as agreed upon between the purchaser
capability-aged condition.
and the supplier. Test Methods E10, E18, E384, and Hardness
Conversion Tables in E140 shall be used.
5.2 Finishes for Plate:
7.2.2 Hardness values are for information only and shall not
5.2.1 Types of finish available for plate are ground finish
be used as a basis for rejection.
produced by surface grinding or continuous belt sanding and
dull finish produced by chemical descaling.
8. Microstructure Requirements
5.3 Finishes for Sheet and Foil:
8.1 If supplied in the annealed condition, the average grain
5.3.1 Types of finish available for sheet and foil are dull
size shall be predominantly ASTM grain size number four or
cold rolled, bright cold rolled, intermediate polished, general-
finer when tested in accordance with Test Methods E112.
purpose polished, dull satin-finished, high luster finish, mirror
8.1.1 It is preferable that samples for grain size determina-
finish, or as specified in the purchase order.
tion be selected after the final annealing operation and prior to
5.4 Edges for Plate:
a final cold-working operation or prior to final cold-working
5.4.1 Rolled edge or approximate square edge produced by
and capability-aging operations.
abrasive sawing.
8.1.2 If samples are selected after a final cold-working
5.5 Edges for Sheet and Foil: operation or after final cold-working and capability-aging
5.5.1 For sizes greater than 1.5 mm [0.060 in.] in thickness,
operations, specimens shall be tested in accordance with Test
an approximate square edge produced by abrasive sawing; for Methods E112, or as agreed upon between the supplier and
sizes under 1.5 mm [0.060 in.], an edge produced by slitting or
purchaser.
shearing.
9. Dimensions and Permissible Variation
6. Chemical Requirements
9.1 Units of Measure:
6.1 The heat analysis and product analysis tolerances shall
9.1.1 Selection—This specification requires that the pur-
conform to the requirements for chemical composition as
chaserselecttheunitsofmeasure(SIorinch-pound)tobeused
specified in Specification F562.
for product certification. In the absence of a stated selection
...

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
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
2.1 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:
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.
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.
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.
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
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 certification—SI or inch-pound;
4.1.4 Form (plate, sheet, foil);
4.1.5 Condition (see 5.1);
4.1.6 Mechanical properties (if applicable for special conditions);
4.1.7 Finish (see 5.2 and 5.3);
4.1.8 Edge (see 5.4 and 5.5);
4.1.9 Applicable dimensions, including size, thickness, width, and length (exact, random, or multiples) or print number;
4.1.10 Special tests (if any); and
4.1.11 Other requirements.
5. Manufacture
5.1 Condition—Plate, sheet, and foil shall be furnished as specified in the annealed, cold-worked, or cold-worked and
capability-aged condition.
5.2 Finishes for Plate:
5.2.1 Types of finish available for plate are ground finish produced by surface grinding or continuous belt sanding and dull finish
produced by chemical descaling.
5.3 Finishes for Sheet and Foil:
5.3.1 Types of finish available for sheet and foil are dull cold rolled, bright cold rolled, intermediate polished, general-purpose
polished, dull satin-finished, high luster finish, mirror finish, or as specified in the purchase order.
5.4 Edges for Plate:
5.4.1 Rolled edge or approximate square edge produced by abrasive sawing.
5.5 Edges for Sheet and Foil:
5.5.1 For sizes greater than 1.5 mm [0.060 in.] in thickness, an approximate square edge produced by abrasive sawing ; For
sawing; for sizes under 1.5 mm [0.060 in.]in.], an edge produced by slitting or shearing.
6. Chemical Requirements
6.1 The heat analysis and product analysis tolerances shall conform to the requirements for chemical composition as specified
in Specification F562.
7. Mechanical Requirements
7.1 Tensile Properties:
7.1.1 Tensile properties for plate and sheet shall be determined in accordance with Test Methods E8/E8M while tensile
properties for foil shall be determined in accordance with Test Methods E345.
7.1.2 Perform at least one tension test from each lot. Should any of the test pieces not meet the specified requirements, test two
additional test pieces representative of the same lot, in the same manner, for each failed test piece. The lot shall be considered in
compliance only if all additional test pieces meet the specified requirements.
7.1.3 Tensile test results for which any specimen fractures outside the gage length shall be considered acceptable if the
elongation meets the minimum requirements specified. Refer to Test Methods E8/E8M, section 7.11.4. If the elongation is less than
the minimum requirement, discard the test and retest. Retest one specimen for each specimen that did not meet the minimum
requirement.
7.1.4 Product forms in the annealed condition shall meet the mechanical property requirements specified in Table 1.
7.1.5 Sheet product in the 48 % cold-worked condition shall meet the mechanical property requirements specified in Table 1.
Other product forms and cold-worked conditions shall meet the mechanical property requirements as agreed upon between the
supplier and purchaser.
7.1.6 Product forms in the cold-worked and capability-aged condition shall meet the mechanical property requirements as
agreed upon between the supplier and purchaser.
7.2 Hardness:
F688 − 19
TABLE 1 Sheet Mechanical Properties
Ultimate Tensile Yield Strength Elongation, Rockwell
Strength, min, (0.2 % offset), min, % in Hardness,
Condition
A A
MPa [psi] min, MPa [psi] 50 mm or min
2 in.
B
Annealed 792 [115 000] 310 [45 000] 45 87 HRB
48 % cold worked
1357 [197 000] 1343 [195 000] 3 43 HRC
A
Tensile and yield requirements apply to tests taken longitudinally to the rolling
direction.
B
0.5 mm [0.0197 in.] sheet, vacuum annealed at 1022°C [1875°F],
...