ASTM F543-17
Standard Specification and Test Methods for Metallic Medical Bone Screws

Standard No.

ASTM F543-17

Release Date

2017

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F543-23

Latest

ASTM F543-23

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 SelfTapping 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 and health 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.

ASTM F543-17 Referenced Document

• ASTM E122 Standard Practice for Calculating Sample Size to Estimate, With a Specified Tolerable Error, the Average for Characteristic of a Lot or Process
• ASTM E4 Standard Practices for Force Verification of Testing Machines
• ASTM E6 Standard Terminology Relating to Methods of Mechanical Testing
• ASTM E8 Standard Test Methods for Tension Testing of Metallic Materials
• ASTM F116 Standard Specification for Medical Screwdriver Bits*， 2021-02-01 Update
• ASTM F1295 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
• ASTM F1314 Standard 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)
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
• ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)*， 2020-03-01 Update
• ASTM F1586 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium8212;10 Nickel8212;3 Manganese8212;2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
• ASTM F1713 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications
• ASTM F1813 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
• ASTM F1839 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
• ASTM F2066 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)*， 2023-04-01 Update
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment*， 2023-04-01 Update
• ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments*， 2021-04-01 Update
• ASTM F620 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition*， 2020-02-01 Update
• ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F799 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants*， 2021-06-01 Update
• ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components*， 2018-02-01 Update

ASTM F543-17 history

• 2023 ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2017 ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2013 ASTM F543-13e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2013 ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2007 ASTM F543-07e2 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2007 ASTM F543-07e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2007 ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2002 ASTM F543-02e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2002 ASTM F543-02 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2001 ASTM F543-01e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2001 ASTM F543-01 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 2000 ASTM F543-00 Standard Specification and Test Methods for Metallic Medical Bone Screws
• 1998 ASTM F543-98 Standard Specification and Test Methods for Metallic Medical Bone Screws