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ASTM F543-01e1

(Specification)

Standard Specification and Test Methods for Metallic Medical Bone Screws

Standard Specification and Test Methods for Metallic Medical Bone Screws

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—Specifications for Type HA and Type HB Metallic Bone Screws.
1.2.5 Annex A5—Specifications for Type HC and Type HD Metallic Bone Screws.
1.2.6 Annex A6—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.
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
09-Apr-2002
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 F543-01 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
10-Apr-2002
Replaced By
ASTM F543-02 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
10-Apr-2002
Referred By
ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
10-Apr-2002
Referred By
ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Effective Date
10-Apr-2002
Referred By
ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Effective Date
10-Apr-2002
Referred By
ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
Effective Date
10-Apr-2002
Referred By
ASTM F897-19 - Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Effective Date
10-Apr-2002
Referred By
ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Effective Date
10-Apr-2002
Referred By
ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
Effective Date
10-Apr-2002
Referred By
ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
Effective Date
10-Apr-2002
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
10-Apr-2002

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ASTM F543-01e1 - Standard Specification and Test Methods for Metallic Medical Bone ScrewsASTM F543-01e1 - Standard Specification and Test Methods for Metallic Medical Bone Screws
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ASTM F543-01e1 - 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 discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 543 – 01
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 (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
e NOTE—The drive connections pictured in Figs. A6.6 and A6.7 were inadvertently reversed. This was editorially corrected in
July 2001.
1. Scope determine the applicability of regulatory limitations prior to
use.
1.1 This specification provides requirements for materials,
finish and marking, care and handling, and the acceptable
2. Referenced Documents
dimensions and tolerances for metallic bone screws that are
2.1 ASTM Standards:
implanted into bone. The dimensions and tolerances in this
2
E 4 Practices for Force Verification of Testing Machines
specification are applicable only to metallic bone screws
E 6 Terminology Relating to Methods of Mechanical Test-
described in this specification.
2
ing
1.2 This specification provides performance considerations
2
E 8 Test Methods for Tension Testing of Metallic Materials
and standard test methods for measuring mechanical properties
E 122 Practice for Choice of Sample Size to Estimate a
in torsion of metallic bone screws that are implanted into bone.
3
Measure of Quality for a Lot or Process
These test methods may also be applicable to other screws
F 67 Specification for Unalloyed Titanium for Surgical
besides those whose dimensions and tolerances are specified
4
Implant Applications
here. The following annexes are included:
F 86 Practice for Surface Preparation and Marking of Me-
1.2.1 Annex A1—Test Method for Determining the Tor-
4
tallic Surgical Implants
sional Properties of Metallic Bone Screws.
4
F 116 Specification for Medical Screwdriver Bits
1.2.2 Annex A2—Test Method for Driving Torque of Medi-
F 117 Test Method for Driving Torque of Medical Bone
cal Bone Screws.
4
Screws
1.2.3 Annex A3—Test Method for Determining the Axial
F 136 Specification for Wrought Titanium – 6 Aluminum –
Pullout Strength of Medical Bone Screws.
4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS
1.2.4 Annex A4—Specifications for Type HA and Type HB
4
R56401) for Surgical Implant Applications
Metallic Bone Screws.
F 138 Specification for Wrought 18 Chromium-14 Nickel-
1.2.5 Annex A5—Specifications for Type HC and Type HD
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
Metallic Bone Screws.
4
Implants (UNS S31673)
1.2.6 Annex A6—Specifications for Metallic Bone Screw
F 565 Practice for Care and Handling of Orthopedic Im-
Drive Connections.
4
plants and Instruments
1.3 This specification is based, in part, upon ISO 5835, ISO
F 620 Specification for Titanium-6 Aluminum-4 Vanadium
6475 and ISO 9268.
4
ELI Alloy Forgings for Surgical Implants [UNS R56401]
1.4 Unless otherwise indicated, the values stated in SI units
F 799 Specification for Cobalt-28 Chromium-6 Molybde-
are to be regarded as standard. The values in parentheses are
num Alloy Forgings for Surgical Implants (UNS R31537,
given for information only.
4
R31538, R31539)
1.5 This standard may involve the use of hazardous mate-
F 983 Practice for Permanent Marking of Orthopedic Im-
rials, operations, and equipment. This standard does not
4
plant Components
purport to address all of the safety concerns, if any, associated
F 1295 Specification for Wrought Titanium-6 Aluminum-7
with its use. It is the responsibility of the user of this standard
Niobium Alloy for Surgical Implant Applications [UNS
to establish appropriate safety and health practices and
4
R56700]
F 1314 Specification for Wrought Nitrogen
Strengthened-22 Chromium-12.5 Nickel-5 Manganese-2.5
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 F04.21 on Osteosynthesis. Annual Book of ASTM Standards, Vol 03.01.
3
Current edition approved May 10, 2001. Published May 2001. Originally Annual Book of ASTM Standards, Vol 14.02.
4
published as F 543 – 77. Last previous edition F 543 – 00. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 543
Molybdenum Stainless Steel Bar and Wire for Surgical 3.1.3 buttress thread—an asymmetrical thread profile char-
4
Implants acterized by a pressure flank which is nearly perpendicular to
F 1472 Specification for Wrought Titanium-6 Aluminum-4 the screw axis
Vanadium Alloy for Surgical Implant Applications
...

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

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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).  
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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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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.

  • Guide
    8 pages
    English language
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  • Guide
    8 pages
    English language
    sale 15% off