ASTM F543 - 13e1

    Standard Specification and Test Methods for Metallic Medical Bone Screws

    Active Standard ASTM F543 | Developed by Subcommittee: F04.21

    Book of Standards Volume: 13.01


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    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.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    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.

    1. 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 Strength 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, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required.

    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 and health practices and determine the applicability of regulatory limitations prior to use.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E4 Practices for Force Verification of Testing Machines

    E6 Terminology Relating to Methods of Mechanical Testing

    E8 Test Methods for Tension Testing of Metallic Materials

    E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process

    F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

    F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants

    F116 Specification for Medical Screwdriver Bits

    F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

    F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

    F565 Practice for Care and Handling of Orthopedic Implants and Instruments

    F620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

    F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

    F983 Practice for Permanent Marking of Orthopaedic Implant Components

    F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

    F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

    F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

    F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

    F1586 Specification for Wrought Nitrogen Strengthened 21Chromium--10Nickel--3Manganese--2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

    F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

    F1813 Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)

    F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

    F2066 Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

    ISO Standards

    10664 Hexalobular Internal Driving Feature for Bolts and Screws

    5835 Implants for Surgery--Metal Bone Screws with Hexagonal Driver Connection, Spherical Under Surface of Head, Asymmetrical Thread--Dimensions

    6475 Implants for Surgery--Metal Bone Screws with Asymmetrical Thread and Spherical Under-Surface--Mechanical Requirements and Test Methods

    8319-1 Orthopaedic Instruments--Drive connections--Part 1: Keys for use with hexagon socket heads

    8319-2 Orthopaedic Instruments--Drive connections--Part 2: Screwdrivers for single slot head screws, screws with cruciate and cross-ecessed head screws

    9268 Implants for Surgery--Metal Bone Screws with Conical Under-Surface of Head--Dimensions


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42321506(Bone screw)


    DOI: 10.1520/F0543

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