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ASTM F75-01

(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)

SCOPE
1.1 This specification provides 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 of inch-pound units may be approximate.

General Information

Status
Historical
Publication Date
09-Dec-2001
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 F75-98 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
10-Dec-2001
Replaced By
ASTM F75-07 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Effective Date
01-Jan-2007
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
10-Dec-2001
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
10-Dec-2001
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
10-Dec-2001
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
10-Dec-2001
Referred By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
10-Dec-2001
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-Dec-2001
Referred By
ASTM F1377-21 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
Effective Date
10-Dec-2001
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
10-Dec-2001
Referred By
ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
Effective Date
10-Dec-2001
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
10-Dec-2001
Referred By
ASTM F763-22 - Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
Effective Date
10-Dec-2001
Referred By
ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
Effective Date
10-Dec-2001
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
10-Dec-2001

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ASTM F75-01 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)ASTM F75-01 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
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ASTM F75-01 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
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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 75 – 01
Standard Specification for
Cobalt-28 Chromium-6 Molybdenum Alloy Castings and
1
Casting Alloy for Surgical Implants (UNS R30075)
ThisstandardisissuedunderthefixeddesignationF 75;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (e) indicates an editorial change since the last revision or reapproval.
8
1. Scope* 2.3 ISO Standards:
ISO 5832-4 Implants for Surgery—Metallic Materials—
1.1 This specification provides the requirements for
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
cobalt-28 chromium-6 molybdenum alloy unfinished invest-
ISO 6892 Metallic Materials Tensile Testing at Ambient
ment product castings for surgical implant applications and
Temperature
casting alloy in the form of shot, bar, or ingots to be used in the
9
2.4 American Society for Quality Standard:
manufacture of surgical implants. This specification does not
ASQ Cl Specification of General Requirements for a Qual-
apply to completed surgical implants made from castings.
ity Program
1.2 The values stated in inch-pound units are to be regarded
as the standard.The SI equivalents of inch-pound units may be
3. Ordering Information
approximate.
3.1 Inquiries and orders for material under this specification
2. Referenced Documents shall include the following information:
3.1.1 Quantity (number of product castings or weight of
2.1 ASTM Standards:
2
casting alloy),
E 3 Practice for Preparation of Metallographic Specimens
2
3.1.2 ASTM designation and date of issue,
E 8 TestMethodsforTensionTestingofMetallicMaterials
3.1.3 Form (product casting, shot, bar, ingot),
E 18 Test Methods for Rockwell Hardness and Rockwell
2
3.1.4 Applicable dimensions or drawing number,
Superficial Hardness of Metallic Materials
3
3.1.5 Condition (as-cast, hot isostatically pressed (HIP),
E 165 Test Method for Liquid Penetrant Examination
2
solution annealed, and so forth),
E 407 Practice for Microetching Metals and Alloys
3.1.6 Special tests, if any, and
E 601 Practice for Fluorescent Penetrant Inspection of Me-
4
3.1.7 Other requirements.
tallic Surgical Implants
E 629 Practice for Radiography of Cast Metallic Surgical
4. Materials and Manufacturing Requirements for
5
Implants
Product Castings
F 981 Practice for Assessment of Compatibility of Bioma-
4.1 Final thermal processing for castings, if any, shall be
terials for Surgical Implants with Respect to Effect of
6 specified by mutual agreement between the supplier and
Materials on Muscle and Bone
7 purchaser.
2.2 Aerospace Material Specification:
4.2 Castings shall be free of visible investment shell mate-
AMS2248 ChemicalCheckAnalysisLimits:Corrosionand
rial and scale when examined without magnification.
Heat Resistant Steels and Alloys, Maraging and Other
4.3 Welding may be used to repair castings as agreed upon
Highly-Alloyed Steels, and Iron Alloys
between supplier and purchaser.
AMS 2269 Chemical Check Analysis Limits: Nickel,
4.3.1 Weld repair shall be performed in accordance with
Nickel Alloys and Cobalt Alloys
written procedures by individuals certified to perform those
procedures.
1
4.3.2 Weld filler metal conforming to the chemistry ofTable
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
1 shall be used when it is needed.
Subcommittee F04.12 on Metallurgical Materials.
4.3.3 Weld repair, if any, shall be performed before final
Current edition approved Dec. 10, 2001. Published February 2002. Originally
thermal processing.
published as F 75 – 67. Last previous edition F 75 – 98.
2
Annual Book of ASTM Standards, Vol 03.01.
3
Annual Book of ASTM Standards, Vol 03.03.
4
Annual Book of ASTM Standards, Vol 14.03.
5 8
Discontinued; See 1996 Annual Book of ASTM Standards, Vol 11.05. Available from American National Standards Institute, 25 W. 43rd St., 4th
6
Annual Book of ASTM Standards, Vol 13.01. Floor, New York, NY 10036.
7 9
Available from Society of Automotive Engineers, 400 Commonwealth Dr., Available from American Society for Quality, 600 N. Plankinton Ave.,
Warrendale, PA 15096-0001. 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 ----------------------
F75–01
A
TABLE 1 Chemical Composition TABLE 2 Product Analysis Tolerances
B,C
Composition, % (Mass/Mass) Tolerance,
Element
Element
% (Mass/Mass)
min max
Chromium 0.30
Chromium 27.00 30.00
Molybdenum 0.15
Molybdenum 5.00 7.00
Nickel 0.05
Nickel . 0.50
Iron 0.03
Iron . 0.75
Carbon 0.02
Carbon . 0.35
Silicon 0.05
Silicon . 1.00
M
...

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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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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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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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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.

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