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ASTM F562-07

(Specification)

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

ABSTRACT
This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work-strengthening, and work-strengthening and aging to attain a variety of combinations of strength and ductility. Materials shall be tested and the individual grades shall conform to chemical requirements such as chemical composition and their tolerances, and mechanical properties such as tensile strength, yield strength, elongation, and area reduction.
SCOPE
1.1 This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work-strengthening, and work-strengthening and aging to attain a variety of combinations of strength and ductility.
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of the inch-pound units may be approximate.

General Information

Status
Historical
Publication Date
31-May-2007
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 F562-02 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
Effective Date
01-Jun-2007
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Jun-2007
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-Jun-2007
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Jun-2007
Referred By
ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
Effective Date
01-Jun-2007
Referred By
ASTM F961-20 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Effective Date
01-Jun-2007
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
01-Jun-2007
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Jun-2007
Referred By
ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
01-Jun-2007
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
01-Jun-2007
Referred By
ASTM E2948-22 - Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire
Effective Date
01-Jun-2007
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
01-Jun-2007
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
01-Jun-2007
Referred By
ASTM F2527-16 - Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
Effective Date
01-Jun-2007
Referred By
ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
Effective Date
01-Jun-2007

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ASTM F562-07 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)ASTM F562-07 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
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ASTM F562-07 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (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:F562 −07
StandardSpecification for
Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum
1
Alloy for Surgical Implant Applications (UNS R30035)
ThisstandardisissuedunderthefixeddesignationF562;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* 2.3 Aerospace Material Specification:
AMS 2269 Chemical Check Analysis Limits—Wrought
1.1 This specification covers requirements of wrought
4
Nickel Alloys and Cobalt Alloys
35cobalt-35nickel-20chromium-10molybdenum alloy (UNS
2.4 American Society for Quality Standard:
R30035) in the form of bar and wire, used for the manufacture
ASQ C1 Specification of General Requirements for a Qual-
of surgical implants. This alloy depends on combinations of
5
ity Program
work-strengthening, and work-strengthening and aging to at-
2.5 Society of Automotive Engineers:
tain a variety of combinations of strength and ductility.
SAE J1086 Practice for Numbering Metals and Alloys
1.2 The values stated in inch-pound units are to be regarded
4
(UNS)
asthestandard.TheSIequivalentsoftheinch-poundunitsmay
be approximate.
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
2. Referenced Documents
3.1.1 lot—the total number of mill products produced from
2
2.1 ASTM Standards:
the same melt heat under the same conditions at essentially the
A751 Test Methods, Practices, and Terminology for Chemi-
same time.
cal Analysis of Steel Products
E8 Test Methods for Tension Testing of Metallic Materials
4. Classification
E29 Practice for Using Significant Digits in Test Data to
4.1 Bar—Round, rectangular, or other complex-shaped
Determine Conformance with Specifications
product delivered straightened and cut to defined lengths, with
E112 Test Methods for Determining Average Grain Size
2 2
a maximum cross-sectional area of 16 in. (103 cm ).
E354 Test Methods for Chemical Analysis of High-
4.2 Wire—Round, rectangular, or other complex-shaped
Temperature,Electrical,Magnetic,andOtherSimilarIron,
product produced and delivered in coils.
Nickel, and Cobalt Alloys
F981 Practice for Assessment of Compatibility of Biomate-
4.3 Fine Wire—Wire with diameter or major dimension less
rials for Surgical Implants with Respect to Effect of
than 0.63 in. (1.6 mm).
Materials on Muscle and Bone
5. Ordering Information
2.2 ISO Standards:
ISO 5832/6 Implants for Surgery—Metallic Materials Part
5.1 Inquiries and orders for material under this specification
3
6: Wrought cobalt-nickel-chromium-molybdenum alloy
shall include the following information:
ISO 6892 Metallic Materials—Tensile Testing at Ambient
5.1.1 Quantity,
3
Temperature
5.1.2 ASTM designation and date of issue,
ISO 9001 Quality Management Systems
5.1.3 Mechanical properties (Section 8),
5.1.4 Form (bar or wire),
1 5.1.5 Applicable dimensions, including size, thickness,
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of width, and length (exact, random, multiples), or drawing
Subcommittee F04.12 on Metallurgical Materials.
number,
CurrenteditionapprovedJune1,2007.PublishedJuly2007.Originallyapproved
5.1.6 Condition (6.1),
in1978.Lastpreviouseditionapprovedin2002asF562 – 02.DOI:10.1520/F0562-
5.1.7 Finish (6.2),
07.
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 from Society of Automotive Engineers, Inc., 400 Commonwealth
the ASTM website. Drive, Warrendale, PA 15096–0001.
3 5
AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700 Available from American Society for Quality, 600 N. Plankinton Ave.,
Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS. Milwaukee, WI 53203.
*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 ----------------------
F562−07
A,B
TABLE 2 Product Analysis Tolerances
5.1.8 Special tests, if applicable, and
Tolerance Under the
5.1.9 Other requirements.
Minimum or
Element
Over the Maximum Limit %
6. Materials and Manufacture
C
(mass/mass)
Carbon 0.01
6.1 Condition—Bar and wire shall be furnished, as
Manganese 0.03
specified, in the solution-annealed, cold-worked, or cold-
Silicon 0.02
worked and aged condition.
Phosphorus 0.005
Sulfur 0.005
6.2 Finish—Bar and wire shall be furnished in the cold
Chromium 0.25
drawn,pickled,ground,orgroundandpolished,asspecifiedby
Nickel 0.3
...

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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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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 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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