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ASTM F799-06

(Specification)

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

Standard Specification for Cobalt-28Chromium-6Molybdenum 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-28chromium-6molybdenum 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 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.
1.3 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 F 1537.

General Information

Status
Historical
Publication Date
30-Sep-2006
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 F799-02 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
01-Oct-2006
Replaced By
ASTM F799-11 - Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
01-Jun-2011
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Oct-2006
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
01-Oct-2006
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
01-Oct-2006
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-Oct-2006
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-Oct-2006
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
01-Oct-2006
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
01-Oct-2006
Referred By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
01-Oct-2006
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Oct-2006
Referred By
ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Effective Date
01-Oct-2006
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
01-Oct-2006
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
01-Oct-2006
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
01-Oct-2006

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ASTM F799-06 - Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)ASTM F799-06 - Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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ASTM F799-06 - Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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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: F799 – 06
Standard Specification for
Cobalt-28Chromium-6Molybdenum 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* tallic Surgical Implants
F981 Practice forAssessment of Compatibility of Biomate-
1.1 This specification covers requirements of cobalt-
rials for Surgical Implants with Respect to Effect of
28chromium-6molybdenum alloy (UNS R31537, R31538,
Materials on Muscle and Bone
R31539)high-strengthforgingsforthemanufactureofsurgical
F1537 Specification for Wrought Cobalt-28Chromium-
implants.The properties specified in this document specifically
6MolybdenumAlloysforSurgicalImplants(UNSR31537,
apply to finished or semifinished parts that receive no subse-
UNS R31538, and UNS R31539)
quent thermomechanical processing.
3
2.2 ISO Standards:
1.2 The values stated in inch-pound units are to be regarded
ISO 6892 Metallic Materials—Tensile Testing at Ambient
as standard. The values given in parentheses are mathematical
Temperature
conversions to SI units that are provided for information only
ISO 9001 Quality Management Systems—Requirements
and are not considered standard.
4
2.3 American Society for Quality Standard:
1.3 Wrought material to be used as forging stock in the
ASQ C1 Specification of General Requirements for a Qual-
manufacture of forgings conforming to this specification,
ity Program
typically hot worked and unannealed with a surface finish
suitable for forging, shall be fabricated and supplied in
3. Terminology
accordance with F1537.
3.1 Definitions of Terms Specific to This Standard:
2. Referenced Documents 3.1.1 lot, n—thetotalnumberofforgingsproducedfromthe
2
same heat of starting material under the same conditions at
2.1 ASTM Standards:
essentially the same time.
E8 Test Methods for Tension Testing of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Ma-
4. Ordering Information
terials
4.1 Inquiries and orders for material under this specification
E29 Practice for Using Significant Digits in Test Data to
shall include the following information:
Determine Conformance with Specifications
4.1.1 Quantity, number of pieces
E112 Test Methods for Determining Average Grain Size
4.1.2 ASTM designation, date of issue, and alloy number,
E165 PracticeforLiquidPenetrantExaminationforGeneral
4.1.3 Condition,
Industry
4.1.4 Mechanical properties,
E930 Test Methods for Estimating the Largest Grain Ob-
4.1.5 Finish,
served in a Metallographic Section (ALA Grain Size)
4.1.6 Applicable dimensions or drawing number,
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
4.1.7 Special tests, if any, and
Alloy Castings and Casting Alloy for Surgical Implants
4.1.8 Other requirements.
(UNS R30075)
F601 Practice for Fluorescent Penetrant Inspection of Me-
5. Materials and Manufacture
5.1 Materials for forgings shall be bar, rod, or wire fabri-
cated in accordance with Specification F1537.
1
This specification is under the jurisdiction of ASTM Committee F04 on
5.2 The material shall be forged by hammering, pressing,
Medical and Surgical Materials and Devices and is the direct responsibility of
rolling, extruding, or upsetting, and shall be processed, if
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2006. Published October 2006. Originally
approved in 1982. Last previous edition approved in 2002 as F799 – 02. DOI:
10.1520/F0799-06.
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 ----------------------
F799 – 06
practical, so as to cause metal flow during the hot-working 7.1.6 In some instances, mechanical test pieces may not be
operation to be in the most favorable direction for resisting obtainable directly from forged parts due to their configuration
stresses encountered in service, as may be indicated to the or small size. Instead of mechanical testing, these parts shall
supplier by the purchaser.
...

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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.
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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.  
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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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