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ASTM F543-07

(Specification)

Standard Specification and Test Methods for Metallic Medical Bone Screws

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.
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 A 2 - 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 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.
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.
1.5 This annex specifies the requirements for a variety of drive connections that can be implemented in metallic medical bone screws. The screw's drive connection supplies the interconnection that is typically used in orthopedic surgery for inserting and removing bone screws.

General Information

Status
Historical
Publication Date
31-May-2007
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaces
ASTM F543-02e1 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-Jun-2007
Replaced By
ASTM F543-07e1 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-Jun-2007
Referred By
ASTM F1839-08(2021) - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
Effective Date
01-Jun-2007
Referred By
ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
Effective Date
01-Jun-2007
Referred By
ASTM F897-19 - Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Effective Date
01-Jun-2007
Referred By
ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Effective Date
01-Jun-2007
Referred By
ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Effective Date
01-Jun-2007
Referred By
ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Effective Date
01-Jun-2007
Referred By
ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
Effective Date
01-Jun-2007
Referred By
ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
01-Jun-2007
Referred By
ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
Effective Date
01-Jun-2007

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ASTM F543-07 - Standard Specification and Test Methods for Metallic Medical Bone ScrewsASTM F543-07 - Standard Specification and Test Methods for Metallic Medical Bone Screws
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ASTM F543-07 - Standard Specification and Test Methods for Metallic Medical Bone Screws
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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 543 – 07
Standard Specification and Test Methods for
1
Metallic Medical Bone Screws
This standard is issued under the fixed designation F543; 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.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope to establish appropriate safety and health practices and
determine the applicability of regulatory limitations prior to
1.1 This specification provides requirements for materials,
use.
finish and marking, care and handling, and the acceptable
dimensions and tolerances for metallic bone screws that are
2. Referenced Documents
implanted into bone. The dimensions and tolerances in this
2
2.1 ASTM Standards:
specification are applicable only to metallic bone screws
E4 Practices for Force Verification of Testing Machines
described in this specification.
E6 Terminology Relating to Methods of Mechanical Test-
1.2 This specification provides performance considerations
ing
andstandardtestmethodsformeasuringmechanicalproperties
E8 Test Methods for Tension Testing of Metallic Materials
intorsionofmetallicbonescrewsthatareimplantedintobone.
E122 Practice for Calculating Sample Size to Estimate,
These test methods may also be applicable to other screws
With a Specified Tolerable Error, the Average for a
besides those whose dimensions and tolerances are specified
Characteristic of a Lot or Process
here. The following annexes are included:
F67 Specification for Unalloyed Titanium, for Surgical
1.2.1 Annex A1—Test Method for Determining the Tor-
Implant Applications (UNS R50250, UNS R50400, UNS
sional Properties of Metallic Bone Screws.
R50550, UNS R50700)
1.2.2 AnnexA2—TestMethodforDrivingTorqueofMedi-
F86 Practice for Surface Preparation and Marking of Me-
cal Bone Screws.
tallic Surgical Implants
1.2.3 Annex A3—Test Method for Determining the Axial
F116 Specification for Medical Screwdriver Bits
Pullout Strength of Medical Bone Screws.
F 136 Specification for Wrought Titanium-6Aluminum-
1.2.4 Annex A4—Test Method for Determining the Self-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
Tapping Performance of Self-Tapping Medical Bone Screws.
Implant Applications (UNS R56401)
1.2.5 AnnexA5—Specifications for Type HAand Type HB
F138 Specification for Wrought 18Chromium-14Nickel-
Metallic Bone Screws.
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
1.2.6 AnnexA6—Specifications forType HC andType HD
Implants (UNS S31673)
Metallic Bone Screws.
F565 Practice for Care and Handling of Orthopedic Im-
1.2.7 Annex A7—Specifications for Metallic Bone Screw
plants and Instruments
Drive Connections.
F620 Specification for Alpha Plus Beta Titanium Alloy
1.3 This specification is based, in part, upon ISO 5835, ISO
Forgings for Surgical Implants
6475, and ISO 9268.
F799 SpecificationforCobalt-28Chromium-6Molybdenum
1.4 Unless otherwise indicated, the values stated in SI units
Alloy Forgings for Surgical Implants (UNS R31537,
are to be regarded as standard. The values in parentheses are
R31538, R31539)
given for information only.
F983 Practice for Permanent Marking of Orthopaedic Im-
1.5 This standard may involve the use of hazardous mate-
plant Components
rials, operations, and equipment. This standard does not
F1295 Specification for Wrought Titanium-6Aluminum-
purport to address all of the safety concerns, if any, associated
7Niobium Alloy for Surgical Implant Applications (UNS
with its use. It is the responsibility of the user of this standard
R56700)
1
This specification is under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee Osteosynthesis. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved June 1, 2007. Published June 2007. Originally Standards volume information, refer to the standard’s Document Summary page on
e1
approved in 1977. Last previous edition approved in 2002 as F543–02 . the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F543–07
F1314 SpecificationforWroughtNitrogenStrengthened22 3.1.2 breaking angle—angle of rotation when the screw
Chromium−13Nickel−5Manganese−2.5Molybdenum fails in torsion as demonstrated by a rapid decrease in the
Stainless Steel Alloy Bar and Wire for Surgical Implants indicated torque.
(UNS S20910)
3.1.3 buttress thread—an asymmetrical thread profile char-
F1
...

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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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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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