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ASTM F562-02

(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)

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
09-Apr-2002
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 F562-00 - Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
Effective Date
10-Apr-2002
Replaced By
ASTM F562-07 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
Effective Date
01-Jun-2007
Referred By
ASTM F688-19 - Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
Effective Date
10-Apr-2002
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
10-Apr-2002
Referred By
ASTM E2948-22 - Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire
Effective Date
10-Apr-2002
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
10-Apr-2002
Referred By
ASTM F961-20 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Effective Date
10-Apr-2002
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
10-Apr-2002
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
10-Apr-2002
Referred By
ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
Effective Date
10-Apr-2002
Referred By
ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
10-Apr-2002
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
10-Apr-2002
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
10-Apr-2002
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
10-Apr-2002
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
10-Apr-2002

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ASTM F562-02 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)ASTM F562-02 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
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ASTM F562-02 - 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: F 562 – 02
Standard Specification for
Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum
1
Alloy for Surgical Implant Applications (UNS R30035)
This standard is issued under the fixed designation F 562; 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 (e) indicates an editorial change since the last revision or reapproval.
7
1. Scope* Nickel Alloys and Cobalt Alloys
2.4 American Society for Quality Standard:
1.1 This specification covers requirements of wrought
ASQ C1 Specification of General Requirements for a Qual-
35cobalt-35nickel-20chromium-10molybdenum alloy (UNS
8
ity Program
R30035) in the form of bar and wire, used for the manufacture
2.5 Society of Automotive Engineers:
of surgical implants. This alloy depends on combinations of
SAE J1086 Practice for Numbering Metals and Alloys
work-strengthening, and work-strengthening and aging to at-
7
(UNS)
tain a variety of combinations of strength and ductility.
1.2 The values stated in inch-pound units are to be regarded
3. Classification
asthestandard.TheSIequivalentsoftheinch-poundunitsmay
3.1 Bar—Round Bars and Flats from 0.1875 in. (4.75 mm)
be approximate.
to 4.00 in. (101.60 mm) in diameter or thickness (other shapes
2. Referenced Documents by special order).
3.2 Wire—Rounds less than 0.1875 in. (4.75 mm) in diam-
2.1 ASTM Standards:
eter.
A 751 Test Methods, Practices, and Terminology for
2
Chemical Analysis of Steel Products
4. Ordering Information
3
E8 TestMethodsforTensionTestingofMetallicMaterials
4.1 Inquiries and orders for material under this specification
E112 Test Methods for Determining the Average Grain
3 shall include the following information:
Size
4.1.1 Quantity,
E 354 Test Methods for Chemical Analysis of High-
4.1.2 ASTM designation and date of issue,
Temperature, Electrical, Magnetic, and Other Similar Iron,
4 4.1.3 Mechanical properties (Section 7),
Nickel, and Cobalt Alloys
4.1.4 Form (bar or wire),
F 981 Practice for Assessment of Compatibility of Bioma-
4.1.5 Applicable dimensions, including size, thickness,
terials for Surgical Implants with Respect to Effect of
5 width, and length (exact, random, multiples), or drawing
Materials on Muscle and Bone
number,
2.2 ISO Standards:
4.1.6 Condition (5.1),
ISO 5832/6 Implants for Surgery—Metallic Materials Part
6 4.1.7 Finish (5.2),
6: Wrought cobalt-nickel-chromium-molybdenum alloy
4.1.8 Special tests, if applicable, and
ISO 6892 Metallic Materials—Tensile Testing at Ambient
6 4.1.9 Other requirements.
Temperature
2.3 Aerospace Material Specification:
5. Materials and Manufacture
AMS 2269 Chemical Check Analysis Limits—Wrought
5.1 Condition—Bar and wire shall be furnished, as speci-
fied, in the solution-annealed, cold-worked, or cold-worked
1
and aged condition.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
5.2 Finish—Types of finish available in bar and wire
Subcommittee F04.12 on Metallurgical Materials.
productsarecolddrawn,pickled,ground,groundandpolished,
Current edition approved April 10, 2002. Published June 2002. Originally
or as specified by the purchaser.
published as F 562 – 78. Last previous edition F 562 – 00.
2
Annual Book of ASTM Standards, Vol 01.03.
3
Annual Book of ASTM Standards, Vol 03.01.
4 7
Annual Book of ASTM Standards, Vol 03.05. Available from Society of Automotive Engineers, Inc., 400 Commonwealth
5
Annual Book of ASTM Standards, Vol 13.01. Drive, Warrendale, PA 15096–0001.
6 8
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 ----------------------
F562–02
A,B
TABLE 2 Product Analysis Tolerances
6. Chemical Requirements
Tolerance Under the Minimum or
6.1 Chemical analysis shall be in accordance with Test
Element
C
Over the Maximum Limit % (mass/mass)
Methods E 354 and A 751.
Carbon 0.01
6.2 The cobalt-35nickel-20chromium-10molybdenum alloy
Manganese 0.03
shall conform to the chemical requirements prescribed inTable
Silicon 0.02
Phosphorus 0.005
1. The supplier shall not ship material that is outside the limits
Sulfur 0.005
specified in Table 1.
Chromium 0.25
6.2.1 Requirements for the major and minor elemental
Nickel 0.30
Molybdenum 0.15
constituents are listed in Table 1. Also listed are important
Iron 0.05
residual elements.Analysis for elem
...

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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.  
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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).  
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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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