ASTM F688-10
(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 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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Designation:F688 −10
StandardSpecification 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* Applications (UNS R30035)
F981 Practice for Assessment of Compatibility of Biomate-
1.1 This specification covers the chemical, mechanical, and
rials for Surgical Implants with Respect to Effect of
metallurgical requirements for wrought cobalt-35nickel-
Materials on Muscle and Bone
20chromium-10molybdenum alloy (UNS R30035) in the form
SI 10 American National Standard for Use of the Interna-
of plate, sheet, and foil to be used in the manufacture of
tional System of Units (SI): The Modern Metric System
surgical implants.
2.2 ISO Standards:
1.2 The values stated in either SI units or inch-pound units 3
ISO 9001 Quality Management Systems—Requirements
are to be regarded separately as standard. The values stated in
each system may not be exact equivalents; therefore, each
3. Terminology
system shall be used independently of the other. Combining
3.1 Definitions of Terms Specific to This Standard:
values from the two systems may result in non-conformance
3.1.1 capability—used to indicate the ability of cold worked
with the standard.
material to attain specific mechanical properties after thermal
aging treatment.
2. Referenced Documents
2 3.1.2 foil—material under 0.13 mm [0.005 in.] in thickness.
2.1 ASTM Standards:
3.1.3 lot—the total number of mill products produced from
E8/E8M Test Methods for Tension Testing of Metallic Ma-
the same melt heat under the same conditions at essentially the
terials
same time.
E10 Test Method for Brinell Hardness of Metallic Materials
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
3.1.5 sheet—as used in this specification, material 0.13 mm
Determine Conformance with Specifications
[0.005 in.] to under 4.75 mm [0.1875 in.] in thickness.
E112 Test Methods for Determining Average Grain Size
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
Hardness, Superficial Hardness, Knoop Hardness, and
shall include the following information:
Scleroscope Hardness
4.1.1 Quantity (weight or number of pieces),
E345 Test Methods of Tension Testing of Metallic Foil
4.1.2 ASTM Designation, alloy number, and date of issue,
E384 Test Method for Knoop and Vickers Hardness of
4.1.3 Units to be used for certification—SI or inch-pound,
Materials
4.1.4 Form (plate, sheet, foil),
F562 Specification for Wrought 35Cobalt-35Nickel-
4.1.5 Condition (see 5.1),
20Chromium-10Molybdenum Alloy for Surgical Implant
4.1.6 Mechanical properties (if applicable for special
conditions),
4.1.7 Finish (see 5.2 and 5.3),
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.8 Edge (see 5.4 and 5.5),
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. 4.1.9 Applicable dimensions, including size, thickness,
Current edition approved Dec. 1, 2010. Published December 2010. Originally
width, and length (exact, random, or multiples) or print
approved in 1980. Last previous edition approved in 2005 as F688 – 05. DOI:
number,
10.1520/F0688-10.
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 ----------------------
F688−10
TABLE 1 Sheet Mechanical Properties
4.1.10 Special tests (if any), and
4.1.11 Other requirements. 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
5. Manufacture
2in.
B
Annealed 792 [115 000] 310 [45 000] 45 87 HRB
5.1 Condition—Plate, sheet, and foil shall be furnished as
48 % cold worked
1357 [197 000] 1343 [195 000] 3 43 HRC
sp
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F688–05 Designation: F688 – 10
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*
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.
1.2Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.TheSIequivalentsinparenthesesareforinformation
only.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
E88/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 E92Test Method for
Vickers 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, and Scleroscope Hardness
E345 Test Methods of Tension Testing of Metallic Foil
E384 Test Method for Knoop and Vickers 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 Bone Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
2.2 American Society for Quality Standard: ISO Standards:
3
ASQ C1Specification of General Requirements for a Quality ProgramISO 9001 Quality Management Systems—Requirements
3. Terminology
3.1 Descriptions of Terms Specific to This Standard:
3.1.1 capability—usedtoindicatetheabilityofcoldworkedmaterialtoattainspecificmechanicalpropertiesafterthermalaging
treatment.
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.
CurrenteditionapprovedAug.1,2005.PublishedAugust2005.Originallyapprovedin1980.Lastpreviouseditioinapprovedin2000asF688–00.DOI:10.1520/F0688-05.
Current edition approved Dec. 1, 2010. Published December 2010. Originally approved in 1980. Last previous edition approved in 2005 as F688 – 05. DOI:
10.1520/F0688-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.
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 – 10
3.1.2 foil—material under 0.005 in. (0.127 mm) in thickness. —material under 0.13 mm [0.005 in.] in thickness.
3.1.3 lot—thetotalnumberofmillproductsproducedfromthesamemeltheatunderthesameconditionsatessentiallythesame
time.
3.1.4 plate—as used in this specification, material 0.1875 in. (4.76 mm)4.75 mm [0.1875 in.] and over in thickness.
3.1.5 sheet—as used in this specification, material 0.005 in. (0.127 mm) to under 0.1875 in. (4.76 mm) in thickness. —as used
in this specification, material 0.13 mm [
...
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