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ASTM F961-14

(Specification)

Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

ABSTRACT
This specification covers the chemical composition and mechanical requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) forgings for use in surgical implants. The material covered here shall be in the form of bars, plates, sheets, or wires manufactured in the solution-annealed condition with a finish suitable for forging by hammering, pressing, rolling, extruding, or upsetting.
SCOPE
1.1 This specification covers the requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of forgings, used for the manufacture of surgical implants.  
1.2 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 nonconformance with the standard.

General Information

Status
Historical
Publication Date
30-Sep-2014
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
Current Stage
Ref Project

Relations

Replaces
ASTM F961-08 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Effective Date
01-Oct-2014
Replaced By
ASTM F961-20 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Effective Date
01-Feb-2020

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REDLINE ASTM F961-14 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F961 −14
Standard Specification for
35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Forgings for Surgical Implants (UNS R30035)
ThisstandardisissuedunderthefixeddesignationF961;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* E354 Test Methods for Chemical Analysis of High-
Temperature,Electrical,Magnetic,andOtherSimilarIron,
1.1 This specification covers the requirements for 35cobalt-
Nickel, and Cobalt Alloys
35nickel-20chromium-10molybdenum alloy (UNS R30035) in
F562 Specification for Wrought 35Cobalt-35Nickel-
the form of forgings, used for the manufacture of surgical
20Chromium-10Molybdenum Alloy for Surgical Implant
implants.
Applications (UNS R30035)
1.2 Units—The values stated in either SI units or inch-
F601 Practice for Fluorescent Penetrant Inspection of Me-
pound units are to be regarded separately as standard. The
tallic Surgical Implants
values stated in each system may not be exact equivalents;
F688 Specification for Wrought Cobalt-35Nickel-
therefore,eachsystemshallbeusedindependentlyoftheother.
20Chromium-10MolybdenumAlloy Plate, Sheet, and Foil
Combining values from the two systems may result in noncon-
for Surgical Implants (UNS R30035)
formance with the standard.
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
2. Referenced Documents
Materials on Muscle and Insertion into Bone
2
2.1 ASTM Standards:
IEEE/ASTM SI 10 American National Standard for Use of
A751 Test Methods, Practices, and Terminology for Chemi-
theInternationalSystemofUnits(SI):TheModernMetric
cal Analysis of Steel Products
System
3
E8/E8M Test Methods for Tension Testing of Metallic Ma-
2.2 ISO Standards:
terials
ISO 5832-6 Implants for Surgery–Metallic Materials–Part 6:
E10 Test Method for Brinell Hardness of Metallic Materials
Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy
E18 Test Methods for Rockwell Hardness of Metallic Ma-
ISO 9001 Quality Management Systems—Requirements
4
terials
2.3 American Society for Quality Control Standard:
E29 Practice for Using Significant Digits in Test Data to
ASQ C1 Specification of General Requirements for a Qual-
Determine Conformance with Specifications
ity Program
E92 Test Methods for Vickers Hardness and Knoop Hard-
3. Terminology
ness of Metallic Materials
E112 Test Methods for Determining Average Grain Size
3.1 Definitions of Terms Specific to This Standard:
E140 Hardness Conversion Tables for Metals Relationship
3.1.1 lot, n—the total number of forgings produced from the
Among Brinell Hardness, Vickers Hardness, Rockwell
same heat under the same conditions at essentially the same
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
time.
scope Hardness, and Leeb Hardness
4. Ordering Information
E165 Practice for Liquid Penetrant Examination for General
Industry
4.1 Inquiries and orders for forgings under this specification
shall include the following information:
4.1.1 Quantity,
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.2 ASTM designation and date of issue,
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.3 Mechanical properties (if applicable, for special
Subcommittee F04.12 on Metallurgical Materials
conditions),
Current edition approved Oct. 1, 2014. Published November 2014. Originally
approved in 1985. Last previous edition approved in 2008 as F961 – 08. DOI:
10.1520/F0961-14.
2 3
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.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203, http://www.asq.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 ----------------------
F961−14
4.1.4 Form, 7.2 Number of Tests:
4.1.5 Applicable dimensions, including size, thickness, 7.2.1 Perform at least one tension test from each lot in the
width, and length (exact, random, or multiples), or drawing longitudinal direction. Should this test result not meet the
number, specifiedrequirements,testtwoadditionaltestpiecesrepresen-
4.1.6 Condition, tative of the same lot, in the same manner, for each failed test
4.1.7 Finish, piece.
...

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: F961 − 08 F961 − 14
Standard Specification for
35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Forgings for Surgical Implants (UNS R30035)
This standard is issued under the fixed designation F961; 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 requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the
form of forgings, used for the manufacture of surgical implants.
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given
in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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 nonconformance 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
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
3
E92 Test Method for Vickers Hardness of Metallic Materials (Withdrawn 2010)
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
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
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F688 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical
Implants (UNS R30035)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
4
2.2 ISO Standards:
ISO 5832-6 Implants for Surgery–Metallic Materials–Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy
ISO 9001 Quality Management Systems—Requirements
5
2.3 American Society for Quality Control Standard:
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 Aug. 1, 2008Oct. 1, 2014. Published September 2008November 2014. Originally approved in 1985. Last previous edition approved in 20032008
as F961 – 03.F961 – 08. DOI: 10.1520/F0961-08.10.1520/F0961-14.
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
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.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 ----------------------
F961 − 14
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot, n—the total number of forgings produced from the same heat under the same conditions at essentially the same time.
4. Ordering Information
4.1 Inquiries and orders for forgings under this specification shall include the following informat
...

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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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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