ASTM F543-07e1

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
A1.1.1 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 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 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.

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

Relations

• Replaces: ASTM F543-07 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Jun-2007
• Replaced By: ASTM F543-07e2 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Jun-2007
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• 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

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
´1
Designation:F543 −07
StandardSpecification and Test Methods for
1
Metallic Medical Bone Screws
ThisstandardisissuedunderthefixeddesignationF543;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) 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
ε NOTE—Units information was editorially corrected in August 2009.
1. Scope 1.5 This standard may involve the use of hazardous
materials, operations, and equipment. This standard does not
1.1 This specification provides requirements for materials,
purport to address all of the safety concerns, if any, associated
finish and marking, care and handling, and the acceptable
with its use. It is the responsibility of the user of this standard
dimensions and tolerances for metallic bone screws that are
to establish appropriate safety and health practices and
implanted into bone. The dimensions and tolerances in this
determine the applicability of regulatory limitations prior to
specification are applicable only to metallic bone screws
use.
described in this specification.
2. Referenced Documents
1.2 This specification provides performance considerations
2
andstandardtestmethodsformeasuringmechanicalproperties
2.1 ASTM Standards:
intorsionofmetallicbonescrewsthatareimplantedintobone.
E4Practices for Force Verification of Testing Machines
These test methods may also be applicable to other screws
E6Terminology Relating to Methods of MechanicalTesting
besides those whose dimensions and tolerances are specified
E8Test Methods for Tension Testing of Metallic Materials
here. The following annexes are included:
E122PracticeforCalculatingSampleSizetoEstimate,With
1.2.1 Annex A1—Test Method for Determining the Tor- Specified Precision, the Average for a Characteristic of a
sional Properties of Metallic Bone Screws.
Lot or Process
F67Specification for Unalloyed Titanium, for Surgical Im-
1.2.2 AnnexA2—TestMethodforDrivingTorqueofMedi-
cal Bone Screws. plant Applications (UNS R50250, UNS R50400, UNS
R50550, UNS R50700)
1.2.3 Annex A3—Test Method for Determining the Axial
F86Practice for Surface Preparation and Marking of Metal-
Pullout Strength of Medical Bone Screws.
lic Surgical Implants
1.2.4 Annex A4—Test Method for Determining the Self-
F116Specification for Medical Screwdriver Bits
Tapping Performance of Self-Tapping Medical Bone Screws.
F136 Specification for Wrought Titanium-6Aluminum-
1.2.5 AnnexA5—Specifications for Type HAand Type HB
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
Metallic Bone Screws.
Implant Applications (UNS R56401)
1.2.6 AnnexA6—Specifications forType HC andType HD
F138 Specification for Wrought 18Chromium-14Nickel-
Metallic Bone Screws.
2.5MolybdenumStainlessSteelBarandWireforSurgical
1.2.7 Annex A7—Specifications for Metallic Bone Screw
Implants (UNS S31673)
Drive Connections.
F565PracticeforCareandHandlingofOrthopedicImplants
1.3 This specification is based, in part, upon ISO 5835, ISO
and Instruments
6475, and ISO 9268.
F620Specification for TitaniumAlloy Forgings for Surgical
1.4 The values stated in SI units are to be regarded as Implants in the Alpha Plus Beta Condition
F799Specification for Cobalt-28Chromium-6Molybdenum
standard. No other units of measurement are included in this
Alloy Forgings for Surgical Implants (UNS R31537,
standard.
R31538, R31539)
F983Practice for Permanent Marking of Orthopaedic Im-
plant Components
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved June 1, 2007. Published June 2007. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
ε1
approved in 1977. Last previous edition approved in 2002 as F543–02 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0543-07E01. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
F543−07
F1295 Specification for Wrought Titanium-6Aluminum- 3.1.1 axial pullout strength—the tensile force required to
7Niobium Alloy for Surgical Implant Applications (UNS fail or remove a bone screw from a material into which the
R56700) screw has been inserted.
F1314Specification for Wrought Nitrogen Strengthened 22
3.1.2 breakingangle—angleofrotationwhenthescrewfails
Chromium–13Nickel–5Manganese–2.5Molybdenum
in torsion as demonstrated by a rapid decrease in the indicated
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:F543–07 Designation: F 543 – 07
Standard Specification and Test Methods for
1
Metallic Medical Bone Screws
This standard is issued under the fixed designation F 543; 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 (´) 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
´ NOTE—Units information was editorially corrected in August 2009.
1. Scope
1.1 Thisspecificationprovidesrequirementsformaterials,finishandmarking,careandhandling,andtheacceptabledimensions
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.
1.4Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given
for information only.
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 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
2
2.1 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
E 122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
F67 SpecificationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,UNS
R50700)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F116 Specification for Medical Screwdriver Bits
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
Osteosynthesis.
´1
Current edition approved June 1, 2007. Published June 2007. Originally approved in 1977. Last previous edition approved in 2002 as F 543 – 02 .
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
´1
F543–07
F 565 Practice for Care and Handling of Orthopedic Implants and Instruments
F 620 Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
F 799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F 983 Practice for Permanent Marking of Orthopaedic Im
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F 543–98
ϵ1
Standard Specification for Designation: F543 – 07
Standard Specification and Test Methods for
1
Metallic Medical Bone Screws
ThisstandardisissuedunderthefixeddesignationF543;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (ϵ) 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
ϵ NOTE—Units information was editorially corrected in August 2009.
1. Scope
1.1This specification provides requirements for materials, finish and marking, care and handling, and some dimensions and
tolerances for metallic bone screws which are implanted into bone. The dimensions and tolerances in this specification are
applicable only to metallic bone screws with a spherical head, hexagonal driving slot, and a solid core.
1.2This specification is based, in part, upon ISO 5835.
1.3Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given
for information only.
1.4This 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.
1.1 Thisspecificationprovidesrequirementsformaterials,finishandmarking,careandhandling,andtheacceptabledimensions
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 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
2
2.1 ASTM Standards:
1
This specification is under the jurisdiction of ASTM Committee F-4 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.21 on Osteosynthesis.
Current edition approved Oct. 10, 1998. Published March 1999. Originally published as F 543–77. Last previous edition F 543–92.F04 on Medical and Surgical Materials
and Devices and is the direct responsibility of Subcommittee Osteosynthesis.
ϵ1
Current edition approved June 1, 2007. Published June 2007. Originally approved in 1977. Last previous edition approved in 2002 as F543 – 02 . DOI:
10.1520/F0543-07E01.
2
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
ϵ1
F543 – 07
F67Specification for Unalloyed Titanium for Surgical Implant Applications E4 Practices for Force Verification of Testing
Machines
2
F116Specification for Medical Screwdriver Bits E6 Terminology Relating to Methods of Mechanical Testing
2
F117Test Method for Driving Torque of Medical Bone Screw
...