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 A1Test Method for Determining the Torsional Properties of Metallic Bone Screws.

1.2.2 Annex A2Test Method for Driving Torque of Medical Bone Screws.

1.2.3 Annex A3Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.

1.2.4 Annex A4Specifications for Type HA and Type HB Metallic Bone Screws.

1.2.5 Annex A5Specifications for Type HC and Type HD Metallic Bone Screws.

1.2.6 Annex A6Specifications 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

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

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 Implants (UNS S31673)

F565 Practice for Care and Handling of Orthopedic Implants and Instruments

F620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

F983 Practice for Permanent Marking of Orthopaedic Implant Components

F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

F1314 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)

F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

F1586 Specification for Wrought Nitrogen Strengthened 21Chromium--10Nickel--3Manganese--2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

F1813 Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)

F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

F2066 Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

Keywords

bone screw; dimensions; insertion; performance requirements; pullout; static; test methods; torsion;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0543-00

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