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ASTM F543-13

(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.
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 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.

General Information

Status
Historical
Publication Date
30-Apr-2013
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 F543-07e2 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-May-2013
Replaced By
ASTM F543-13e1 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-May-2013
Referred By
ASTM F897-19 - Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Effective Date
01-May-2013
Referred By
ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Effective Date
01-May-2013
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-May-2013
Referred By
ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
Effective Date
01-May-2013
Referred By
ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
Effective Date
01-May-2013
Referred By
ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
01-May-2013
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ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
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ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
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ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Effective Date
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ASTM F543-13 - Standard Specification and Test Methods for Metallic Medical Bone ScrewsASTM F543-13 - 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:F543 −13
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. Scope only select test methods that are appropriate for a particular
device design. In most instances, only a subset of the herein
1.1 This specification provides requirements for materials,
described test methods will be required.
finish and marking, care and handling, and the acceptable
1.6 This standard may involve the use of hazardous
dimensions and tolerances for metallic bone screws that are
materials, operations, and equipment. This standard does not
implanted into bone. The dimensions and tolerances in this
purport to address all of the safety concerns, if any, associated
specification are applicable only to metallic bone screws
with its use. It is the responsibility of the user of this standard
described in this specification.
to establish appropriate safety and health practices and
1.2 This specification provides performance considerations
determine the applicability of regulatory limitations prior to
andstandardtestmethodsformeasuringmechanicalproperties
use.
intorsionofmetallicbonescrewsthatareimplantedintobone.
These test methods may also be applicable to other screws
2. Referenced Documents
besides those whose dimensions and tolerances are specified
2
2.1 ASTM Standards:
here. The following annexes are included:
E4Practices for Force Verification of Testing Machines
1.2.1 Annex A1—Test Method for Determining the Tor-
E6Terminology Relating to Methods of MechanicalTesting
sional Properties of Metallic Bone Screws.
E8Test Methods for Tension Testing of Metallic Materials
1.2.2 AnnexA2—TestMethodforDrivingTorqueofMedi-
E122PracticeforCalculatingSampleSizetoEstimate,With
cal Bone Screws.
Specified Precision, the Average for a Characteristic of a
1.2.3 Annex A3—Test Method for Determining the Axial
Lot or Process
Pullout Strength of Medical Bone Screws.
F67Specification for Unalloyed Titanium, for Surgical Im-
1.2.4 Annex A4—Test Method for Determining the Self-
plant Applications (UNS R50250, UNS R50400, UNS
Tapping Performance of Self-Tapping Medical Bone Screws.
R50550, UNS R50700)
1.2.5 AnnexA5—Specifications for Type HAand Type HB
F86Practice for Surface Preparation and Marking of Metal-
Metallic Bone Screws.
lic Surgical Implants
1.2.6 AnnexA6—Specifications forType HC andType HD
F116Specification for Medical Screwdriver Bits
Metallic Bone Screws.
F136 Specification for Wrought Titanium-6Aluminum-
1.2.7 Annex A7—Specifications for Metallic Bone Screw
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
Drive Connections.
Implant Applications (UNS R56401)
1.3 This specification is based, in part, upon ISO 5835, ISO
F138 Specification for Wrought 18Chromium-14Nickel-
6475, and ISO 9268.
2.5MolybdenumStainlessSteelBarandWireforSurgical
Implants (UNS S31673)
1.4 The values stated in SI units are to be regarded as
F565PracticeforCareandHandlingofOrthopedicImplants
standard. No other units of measurement are included in this
and Instruments
standard.
F620Specification for TitaniumAlloy Forgings for Surgical
1.5 Multiple test methods are included in this standard.
Implants in the Alpha Plus Beta Condition
However, it must be noted that the user is not obligated to test
F799Specification for Cobalt-28Chromium-6Molybdenum
using all of the described methods. Instead, the user should
Alloy Forgings for Surgical Implants (UNS R31537,
R31538, R31539)
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 May 1, 2013. Published June 2013. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ε1
approved in 1977. Last previous edition approved in 2009 as F543–07 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0543-13. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F543−13
F983Practice for Permanent Marking of Orthopaedic Im-
plant Components
F1295 Specification for Wrought Titanium-6Aluminum-
7Niobium Alloy for Surgical Implant Applications (UNS
R56700)
F1314Specification for Wrought Nitrogen Strengthened 22
Chromium–13 Nickel–5 Manganese–2.
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
´2
Designation: F543 − 07 F543 − 13
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. 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
ε NOTE—Units information was editorially corrected in August 2009.
2
ε NOTE—Editorial changes were made throughout in March 2013.
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
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
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
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.
Current edition approved June 1, 2007May 1, 2013. Published June 2007June 2013. Originally approved in 1977. Last previous edition approved in 20022009 as
ε1
F543 – 02F543 – 07 . DOI: 10.1520/F0543-07E02.10.1520/F0543-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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 ----------------------
F543 − 13
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 Imp
...

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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.

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ASTM
ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
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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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
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.
SCOPE
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.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
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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