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ASTM F799-19

(Specification)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

ABSTRACT
This specification covers the material requirements for low-carbon (UNS R31537), high-carbon (UNS R31538), and dispersion-strengthened (UNS R31539) cobalt-28chromium-6molybdenum alloy high-strength forgings used for the manufacture of surgical implants. The properties specified here specifically apply to finished or semifinished parts that receive no subsequent thermomechanical processing. The materials shall be in the form of bars, rods, or wires suitable for forging by hammering, pressing, rolling, extruding, or upsetting. The forgings shall adhere to chemical composition, ultimate tensile strength, yield strength, elongation, reduction of area, and hardness requirements.
SCOPE
1.1 This specification covers requirements of cobalt-28 chromium-6 molybdenum alloy (UNS R31537, R31538, R31539) high-strength forgings for the manufacture of surgical implants. The properties specified in this document specifically apply to finished or semifinished parts that receive no subsequent thermomechanical processing.  
1.2 Wrought material to be used as forging stock in the manufacture of forgings conforming to this specification, typically hot worked and unannealed with a surface finish suitable for forging, shall be fabricated and supplied in accordance with Specification F1537.  
1.3 Units—The SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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.  
1.4 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.

General Information

Status
Published
Publication Date
14-May-2019
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

Refers
ASTM E8/E8M-15 - Standard Test Methods for Tension Testing of Metallic Materials
Effective Date
01-Feb-2015
Refers
ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
Effective Date
15-Jul-2016
Refers
ASTM E18-17 - Standard Test Methods for Rockwell Hardness of Metallic Materials
Effective Date
01-Jul-2017
Refers
ASTM E18-18 - Standard Test Methods for Rockwell Hardness of Metallic Materials
Effective Date
01-Jul-2018
Refers
ASTM E930-99(2015) - Standard Test Methods for Estimating the Largest Grain Observed in a Metallographic Section (ALA Grain Size)
Effective Date
01-Oct-2015
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
15-May-2019
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses
Effective Date
15-May-2019
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
15-May-2019
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis
Effective Date
15-May-2019
Referred By
ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Effective Date
15-May-2019
Referred By
ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
Effective Date
15-May-2019
Referred By
ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Effective Date
15-May-2019
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
15-May-2019
Referred By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
15-May-2019
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
15-May-2019
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
15-May-2019
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
15-May-2019
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
15-May-2019
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis
Effective Date
15-May-2019

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ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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REDLINE ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)REDLINE ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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Technical specification
REDLINE ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
English language
4 pages
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Standards Content (Sample)

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.
Designation: F799 −19
Standard Specification for
Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for
1
Surgical Implants (UNS R31537, R31538, R31539)
ThisstandardisissuedunderthefixeddesignationF799;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* E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 This specification covers requirements of cobalt-28
E112 Test Methods for Determining Average Grain Size
chromium-6 molybdenum alloy (UNS R31537, R31538,
E165/E165M Practice for Liquid Penetrant Testing for Gen-
R31539)high-strengthforgingsforthemanufactureofsurgical
eral Industry
implants.The properties specified in this document specifically
E930 Test Methods for Estimating the Largest Grain Ob-
apply to finished or semifinished parts that receive no subse-
served in a Metallographic Section (ALA Grain Size)
quent thermomechanical processing.
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
1.2 Wrought material to be used as forging stock in the
Alloy Castings and Casting Alloy for Surgical Implants
manufacture of forgings conforming to this specification,
(UNS R30075)
typically hot worked and unannealed with a surface finish
F601 Practice for Fluorescent Penetrant Inspection of Me-
suitable for forging, shall be fabricated and supplied in
tallic Surgical Implants
accordance with Specification F1537.
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
1.3 Units—The SI units in this standard are the primary
units. The values stated in either primary SI units or secondary Materials on Muscle and Insertion into Bone
F1537 Specification for Wrought Cobalt-28Chromium-
inch-pound units are to be regarded separately as standard.The
values stated in each system may not be exact equivalents; 6Molybdenum Alloys for Surgical Implants (UNS
R31537, UNS R31538, and UNS R31539)
therefore,eachsystemshallbeusedindependentlyoftheother.
Combining values from the two systems may result in non- IEEE/ASTM SI 10 American National Standard for Use of
theInternationalSystemofUnits(SI):TheModernMetric
conformance with the standard.
System
1.4 This international standard was developed in accor-
3
2.2 ISO Standards:
dance with internationally recognized principles on standard-
ISO 6892-1 Metallic materials – Tensile testing – Part 1:
ization established in the Decision on Principles for the
Method of test at room temperature
Development of International Standards, Guides and Recom-
ISO 9001 Quality management systems – Requirements
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
3. Terminology
2. Referenced Documents
3.1 Definitions of Terms Specific to This Standard:
2
3.1.1 lot, n—the total number of forgings produced from the
2.1 ASTM Standards:
same heat of starting material under the same conditions at
E8/E8M Test Methods for Tension Testing of Metallic Ma-
essentially the same time.
terials
E18 Test Methods for Rockwell Hardness of Metallic Ma-
4. Ordering Information
terials
4.1 Inquiries and orders for material under this specification
shall include the following information:
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.1 Quantity, number of pieces
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. 4.1.2 ASTM designation, date of issue, and alloy number,
Current edition approved May 15, 2019. Published June 2019. Originally
4.1.3 Units to be certified (SI or inch-pound),
approved in 1982. Last previous edition approved in 2011 as F799 – 11. DOI:
4.1.4 Condition,
10.1520/F0799-19.
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 ----------------------
F799 − 19
4.1.5 Mechanical properties, specimensmayhaveagroundfinishonthereducedsectionand
4.1.6 Finish, may be taken in a direction parallel t
...

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: F799 − 11 F799 − 19
Standard Specification for
Cobalt-28Chromium-6Molybdenum Cobalt-28 Chromium-6
Molybdenum Alloy Forgings for Surgical Implants (UNS
1
R31537, R31538, R31539)
This standard is issued under the fixed designation F799; 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 requirements of cobalt-28chromium-6molybdenum cobalt-28 chromium-6 molybdenum alloy
(UNS R31537, R31538, R31539) high-strength forgings for the manufacture of surgical implants. The properties specified in this
document specifically apply to finished or semifinished parts that receive no subsequent thermomechanical processing.
1.2 Wrought material to be used as forging stock in the manufacture of forgings conforming to this specification, typically hot
worked and unannealed with a surface finish suitable for forging, shall be fabricated and supplied in accordance with Specification
F1537.
1.3 Units—The SI units in this standard are the primary units. The values stated in either primary SI units or secondary
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.
1.4 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E8E8/E8M Test Methods for Tension Testing of Metallic Materials [Metric] E0008_E0008M
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
E165E165/E165M Practice for Liquid Penetrant Testing for General Industry
E930 Test Methods for Estimating the Largest Grain Observed in a Metallographic Section (ALA Grain Size)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
ASTMIEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric
System
3
2.2 ISO Standards:
ISO 68926892-1 Metallic Materials—Tensile Testing at Ambient Temperaturematerials – Tensile testing – Part 1: Method of test
at room temperature
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 June 1, 2011May 15, 2019. Published June 2011 June 2019. Originally approved in 1982. Last previous edition approved in 20062011 as F799
– 06.11. DOI: 10.1520/F0799-11.10.1520/F0799-19.
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
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 ----------------------
F799 − 19
ISO 9001 Quality Management Systems—Requirements management systems – Requirements
4
2.3 American Society for Quality Standard:
ASQ C1 Specification of General Requirements for a Quality Program
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 h
...

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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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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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