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ASTM F75-07

(Specification)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

ABSTRACT
This specification covers the requirements for unfinished cobalt-28chromium-6molybdenum (UNS R30075) investment product alloy castings for surgical implant applications, and casting alloys of the same in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings. Both product castings and casting alloys shall conform to specified chemical composition and mechanical requirements including ultimate tensile strength, yield strength, elongation, and reduction of area. Product castings shall additional undergo liquid penetrant, radiographic, metallographic, and hardness examination.
SCOPE
1.1 This specification covers the requirements for cobalt-28 chromium-6 molybdenum alloy unfinished investment product castings for surgical implant applications and casting alloy in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings.
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.

General Information

Status
Historical
Publication Date
31-Dec-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 F75-01 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
01-Jan-2007
Replaced By
ASTM F75-12 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
15-May-2012
Referred By
ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
Effective Date
01-Jan-2007
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Jan-2007
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
01-Jan-2007
Referred By
ASTM F647-22 - Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Effective Date
01-Jan-2007
Referred By
ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
Effective Date
01-Jan-2007
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
01-Jan-2007
Referred By
ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
Effective Date
01-Jan-2007
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
01-Jan-2007
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
01-Jan-2007
Referred By
ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
Effective Date
01-Jan-2007
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
01-Jan-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-Jan-2007
Referred By
ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
01-Jan-2007

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ASTM F75-07 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)ASTM F75-07 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
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ASTM F75-07 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
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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: F75 – 07
Standard Specification for
Cobalt-28 Chromium-6 Molybdenum Alloy Castings and
1
Casting Alloy for Surgical Implants (UNS R30075)
This standard is issued under the fixed designation F75; the number immediately following the designation indicates the year of original
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* rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
1.1 This specification covers the requirements for cobalt-28
3
2.2 Aerospace Material Specification:
chromium-6 molybdenum alloy unfinished investment product
AMS2248 ChemicalCheckAnalysisLimits:Corrosionand
castings for surgical implant applications and casting alloy in
Heat Resistant Steels and Alloys, Maraging and Other
the form of shot, bar, or ingots to be used in the manufacture
Highly-Alloyed Steels, and Iron Alloys
of surgical implants. This specification does not apply to
AMS 2269 Chemical Check Analysis Limits: Nickel,
completed surgical implants made from castings.
Nickel Alloys and Cobalt Alloys
1.2 The values stated in inch-pound units are to be regarded
4
2.3 ISO Standards:
as the standard. The SI equivalents in parentheses are for
ISO 5832-4 Implants for Surgery—Metallic Materials—
information only.
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
2. Referenced Documents ISO 6892 Metallic Materials Tensile Testing at Ambient
2
Temperature
2.1 ASTM Standards:
ISO 9001 Quality Management Systems—Requirements
A957 Specification for Investment Castings, Steel and Al-
5
2.4 American Society for Quality Standard:
loy, Common Requirements, for General Industrial Use
ASQ Cl Specification of General Requirements for a Qual-
E3 Guide for Preparation of Metallographic Specimens
ity Program
E8 Test Methods for Tension Testing of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Ma-
3. Terminology
terials
3.1 Definitions of Terms Specific to This Standard:
E29 Practice for Using Significant Digits in Test Data to
3.1.1 investment casting, n—a metal casting that is pro-
Determine Conformance with Specifications
duced in a mold obtained by investing (surrounding) an
E165 PracticeforLiquidPenetrantExaminationforGeneral
expendable pattern with a ceramic slurry that is allowed to
Industry
solidify.The expendable pattern may consist of wax, plastic, or
E354 Test Methods for Chemical Analysis of High-
other material and is removed prior to filling the mold with
Temperature, Electrical, Magnetic, and Other Similar Iron,
liquid metal.
Nickel, and Cobalt Alloys
3.1.2 master heat, n—a quantity of metal processed in a
E407 Practice for Microetching Metals and Alloys
single furnace or refining vessel at one time in such a manner
E601 Test Method for Measuring Electromotive Force
as to produce the desired composition and properties.
(emf) Stability of Base-Metal Thermoelement Materials
3.1.3 sub-heat, n—a portion of a master heat remelted
with Time in Air
without additional processing for pouring into castings. Syn-
F629 Practice for Radiography of Cast Metallic Surgical
onyms: melt, production heat.
Implants
F981 Practice forAssessment of Compatibility of Biomate-
NOTE 1—Terminology section in accordance with Specification A957.
4. Ordering Information
1 4.1 Inquiries and orders for material under this specification
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of shall include the following information:
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Jan. 1, 2007. Published January 2007. Originally
3
approved in 1967. Last previous edition approved in 2001 as F75 – 01. DOI: Available from Society of Automotive Engineers (SAE), 400 Commonwealth
10.1520/F0075-07. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
2 4
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.
5
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 ----------------------
F75–07
4.1.1 Quantity (number of product castings or weight of residual elements.Analysis is not required for
...

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This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
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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.  
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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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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.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off