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ASTM F961-08

(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 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

General Information

Status
Historical
Publication Date
31-Jul-2008
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 F961-03 - Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
Effective Date
01-Aug-2008
Replaced By
ASTM F961-14 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Effective Date
01-Oct-2014

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REDLINE ASTM F961-08 - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 −08
StandardSpecification 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* Nickel, and Cobalt Alloys
F562 Specification for Wrought 35Cobalt-35Nickel-
1.1 This specification covers the requirements for 35cobalt-
20Chromium-10Molybdenum Alloy for Surgical Implant
35nickel-20chromium-10molybdenum alloy (UNS R30035) in
Applications (UNS R30035)
the form of forgings, used for the manufacture of surgical
F601 Practice for Fluorescent Penetrant Inspection of Me-
implants.
tallic Surgical Implants
1.2 The values stated in inch-pound units are to be regarded
F688 Specification for Wrought Cobalt-35Nickel-
as standard. The values given in parentheses are mathematical
20Chromium-10MolybdenumAlloy Plate, Sheet, and Foil
conversions to SI units that are provided for information only
for Surgical Implants (UNS R30035)
and are not considered 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 Bone
2
4
2.1 ASTM Standards:
2.2 ISO Standards:
A751 Test Methods, Practices, and Terminology for Chemi-
ISO 5832-6 Implants for Surgery–Metallic Materials–Part 6:
cal Analysis of Steel Products
Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy
E8 Test Methods for Tension Testing of Metallic Materials
ISO 9001 Quality Management Systems—Requirements
5
E10 Test Method for Brinell Hardness of Metallic Materials
2.3 American Society for Quality Control Standard:
E18 Test Methods for Rockwell Hardness of Metallic Ma-
ASQ C1 Specification of General Requirements for a Qual-
terials
ity Program
E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications 3. Terminology
E92 Test Method forVickers Hardness of Metallic Materials
3.1 Definitions of Terms Specific to This Standard:
3
(Withdrawn 2010)
3.1.1 lot, n—the total number of forgings produced from the
E112 Test Methods for Determining Average Grain Size
same heat under the same conditions at essentially the same
E140 Hardness Conversion Tables for Metals Relationship
time.
Among Brinell Hardness, Vickers Hardness, Rockwell
Hardness, Superficial Hardness, Knoop Hardness, and 4. Ordering Information
Scleroscope Hardness
4.1 Inquiries and orders for forgings under this specification
E165 Practice for Liquid Penetrant Examination for General
shall include the following information:
Industry
4.1.1 Quantity,
E354 Test Methods for Chemical Analysis of High-
4.1.2 ASTM designation and date of issue,
Temperature,Electrical,Magnetic,andOtherSimilarIron,
4.1.3 Mechanical properties (if applicable, for special
conditions),
1 4.1.4 Form,
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.5 Applicable dimensions, including size, thickness,
Subcommittee F04.12 on Metallurgical Materials
width, and length (exact, random, or multiples), or drawing
Current edition approved Aug. 1, 2008. Published September 2008. Originally
number,
approved in 1985. Last previous edition approved in 2003 as F961 – 03. DOI:
4.1.6 Condition,
10.1520/F0961-08.
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
4
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.
3 5
The last approved version of this historical standard is referenced on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
www.astm.org. 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 ----------------------
F961−08
4.1.7 Finish, 7.2.1 Perform at least one tension test from each lot in the
4.1.8 Special tests (if any), and longitudinal direction. Should this test result not meet the
4.1.9 Other requirements. specifiedrequirements,testtwoadditionaltestpiecesrepresen-
tative of the same lot, in the same manner, for each failed test
5. Materials and Manufacture
piece. The lot shall be considered in compliance only if both
additional test pieces meet the specified r
...

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:F961–03 Designation: F 961 – 08
Standard Specification for
35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Forgings for Surgical Implants (UNS R30035)
This standard is issued under the fixed designation F 961; 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*
1.1This specification covers the requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) forgings
for surgical implants.
1.2Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.TheSIequivalentsinparenthesesareforinformation
only.
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 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents
2
2.1 ASTM Standards:
A 751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
E 8 Test Methods for Tension Testing of Metallic Materials
E 10 Test Method for Brinell Hardness of Metallic Materials
3
E 18Test Methods for Rockwell Hardness and Rockwell Superficial Hardness of Metallic Materials Test Methods for
Rockwell Hardness of Metallic Materials
E 29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E 92 Test Method for Vickers Hardness of Metallic Materials
E 112 Test Methods for Determining Average Grain Size
E 140Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness,
3
Superficial Hardness, Knoop Hardness, and Scleroscope Hardness Hardness Conversion Tables for Metals Relationship
Among Brinell Hardness, Vickers Hardness, Rockwell Hardness, Superficial Hardness, Knoop Hardness, and Scleroscope
Hardness
E 165 Test Method for Liquid Penetrant Examination
E 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
F 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F 601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F 688 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical
Implants (UNS R30035)
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
2.2 ISO Standard: ISO Standards:
ISO 5832-6 Implants for Surgery–Metallic Materials–Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy
ISO 9001 Quality Management Systems—Requirements
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 Feb. 10, 2003. Published March 2003. Originally approved in 1985. Last previous edition approved in 1996 as F961–96.
Current edition approved Aug. 1, 2008. Published September 2008. Originally approved in 1985. Last previous edition approved in 2003 as F 961 – 03.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 01.03.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 03.01.
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 ----------------------
F961–08
4
2.3 American Society for Quality Control Standard:
ASQ C1 Specification of General Requirements for a Quality Program
3. Ordering Information
3.1Inquiries and orders for material under this specification shall include the following information:
3.1.1Quantity (weight or number of pieces),
3.1.2ASTM designation and date of issue,
3.1.3Mechanical properties (if
...

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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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ASTM
ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
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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