1. Scope
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants.
1.2 This specification is based, in part, upon ISO 8319-1 and ISO 8319-2.
1.3 The screwdrivers with the bits described in this standard are suitable for use with screws described in F 543, ISO 5835, and ISO 9268.
1.4 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
E18 Test Methods for Rockwell Hardness and Rockwell Superficial Hardness of Metallic Materials
F1744 Practice for Care and Handling of Stainless Steel Surgical Instruments
F543 Specification and Test Methods for Metallic Medical Bone Screws
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F899 Specification for Stainless Steel for Surgical Instruments
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
5832-5Implants for Surgery-Metallic Materials-Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy
5835 Implants for Surgery-Metal Bone Screws with Hexagonal Driver Connection, Spherical Under Surface of Head, Asymmetrical Thread-Dimensions
7153-1 Surgical Instruments-Metallic Materials-Part 1: Stainless Steel
8319-1 Orthopaedic Instruments-Drive Connections-Part 1: Keys for Use with Screws with Hexagon Socket Heads
8319-2 Orthopaedic Instruments-Drive Connections -Part 2: Screwdrivers for Single Slot Head Screws, screws with Cruciate Slot, and Cross-Recessed Head Screws
9268 Implants for Surgery-Metal Bone Screws with Conical Under-Surface of Head-Dimensions
Index Terms
bone screw; orthopaedic medical devices; screwdriver; surgical instruments; ICS Number Code 11.040.30
Citing ASTM Standards
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