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ASTM F799-02

(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)

SCOPE
1.1 This specification covers the material requirements of cobalt-28chromium-6molybdenum alloy high-strength forgings for the manufacture of surgical implants. Material conforming to this specification has been evaluated for biocompatibility and corrosion resistance and has been found to be comparable to material conforming to Specification F 75. The properties specified in this document specifically apply to finished or semifinished parts that receive no subsequent metallurgical processing.  
1.2 The values stated in inch-pound units are to be regarded as the standard. The metric equivalents of the inch-pound units may be approximate.  
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
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 F799-99 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
10-Apr-2002
Replaced By
ASTM F799-06 - Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
01-Oct-2006
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
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ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)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 F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
10-Apr-2002
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
10-Apr-2002
Referred By
ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Effective Date
10-Apr-2002
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
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 F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
10-Apr-2002
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
10-Apr-2002
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
10-Apr-2002
Referred By
ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
Effective Date
10-Apr-2002
Referred By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
10-Apr-2002
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
10-Apr-2002

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ASTM F799-02 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)ASTM F799-02 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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ASTM F799-02 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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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 799 – 02
Standard Specification for
Cobalt-28Chromium-6Molybdenum Alloy Forgings for
1
Surgical Implants (UNS R31537, R31538, R31539)
This standard is issued under the fixed designation F 799; 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.
4
1. Scope* 6Molybdenum Alloys for Surgical Implants
5
2.2 ISO Standards:
1.1 This specification covers requirements of cobalt-
ISO 6892 Metallic Materials—Tensile Testing at Ambient
28chromium-6molybdenum alloy (UNS R31537, R31538,
Temperature
R31539) high-strength forgings for the manufacture of surgical
6
2.3 American Society for Quality Standard:
implants.The properties specified in this document specifically
ASQ C1 Specification of General Requirements for a Qual-
apply to finished or semifinished parts that receive no subse-
ity Program
quent thermomechanical processing.
1.2 The values stated in inch-pound units are to be regarded
3. Ordering Information
asthestandard.TheSIequivalentsoftheinch-poundunitsmay
3.1 Inquiries and orders for material under this specification
be approximate.
shall include the following information:
1.3 Wrought material to be used as forging stock in the
3.1.1 Quantity,
manufacture of forgings conforming to this specification,
3.1.2 ASTM designation, date of issue, and alloy number,
typically hot worked and unannealed with a surface finish
3.1.3 Mechanical properties,
suitable for forging, shall be fabricated and supplied in
3.1.4 Form,
accordance with F 1537.
3.1.5 Applicable dimensions or drawing number,
2. Referenced Documents 3.1.6 Condition,
3.1.7 Special tests, if any, and
2.1 ASTM Standards:
2
3.1.8 Other requirements.
E8 TestMethodsforTensionTestingofMetallicMaterials
E18 Test Methods for Rockwell Hardness and Rockwell
4. Materials and Manufacture
2
Superficial Hardness of Metallic Materials
2 4.1 Materials for forgings shall be bar, rod, or wire fabri-
E112 Test Methods for Determining Average Grain Size
3 cated in accordance with Specification F 1537.
E 165 Test Method for Liquid Penetrant Examination
4.2 The material shall be forged by hammering, pressing,
E 930 Test Methods for Estimating the Largest Grain Ob-
2 rolling, extruding, or upsetting, and shall be processed, if
served in a Metallographic Section (ALA Grain Size)
practicable, so as to cause metal flow during the hot-working
F75 SpecificationforCastCobalt-Chromium-Molybdenum
4 operation to be in the most favorable direction for resisting
Alloy for Surgical Implant Applications
stresses encountered in service, as may be indicated to the
F 601 Practice for Fluorescent Penetrant Inspection of Me-
4 supplier by the purchaser.
tallic Surgical Implants
4.3 Forgings shall be free of splits, scale, cracks, flaws, and
F 981 Practice for Assessment of Compatibility of Bioma-
other imperfections not consistent with good commercial
terials for Surgical Implants with Respect to Effect of
4
practice.
Materials on Muscle and Bone
4.4 Optional indentification marks, including the purchas-
F 1537 Specification for Wrought Cobalt-28Chromium-
er’s logo, material designation, heat code number, and impres-
sionnumber,maybeplaceduponeachforging,themethodand
1
location of which shall be as specified by the purchaser.
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 Apr. 10, 2002. Published June 2002. Originally
5
published as F 799 – 82. Last previous edition F 799 – 99. Available from American National Standards Institute, 25 W. 43rd St., 4th
2
Annual Book of ASTM Standards, Vol 03.01. Floor, New York, NY 10036.
3 6
Annual Book of ASTM Standards, Vol 03.03. Available from American Society for Quality, 600 N. Plankinton Ave.,
4
Annual Book of ASTM Standards, Vol 13.01. 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 ----------------------
F799–02
TABLE 1 Mechanical Requirements
Ultimate Tensile Yield Strength
A
Elongation, in 2 in. or Reduction in Hardness,
Strength, min, (0.2 % offset),
4D or 4W, min % Area, min, % HRC, min
psi, (MPa) min, psi (MPa)
170 000 (1172) 120 000 (827) 12 12 35
A
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gage length of 2 in. or 4D or 4W. The gage length must
be reported with the test results. The method for determining elongation of ma
...

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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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1.5 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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