Active Standard ASTM F116 | Developed by Subcommittee: F04.21
Book of Standards Volume: 13.01
Historical (view previous versions of standard)
This specification covers the acceptable material and dimensional requirements, and tolerances for bits of screwdrivers used for inserting and removing metal screws applied in surgical implants. The medical screwdrivers are available in the following types: Type I—single-slot bit; Type II—cruciate-slot bit; Type III—cross-slot (modified Phillips) bit; Type IV—hexagonal bit; Type V—square bit; Type VI—hexalobe bit. The bit and shaft portion should be fabricated from either martensitic stainless steel or cold worked cobalt-chromium-tungsten-nickel alloy, as specified. The portions should also meet specified values of Rockwell hardness.
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1.3 The screwdrivers with the bits described in this specification are suitable for use with screws described in Specification F543, ISO 5835, and ISO 9268.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E18 Test Methods for Rockwell Hardness of Metallic Materials
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
F543 Specification and Test Methods for Metallic Medical Bone Screws
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F899 Specification for Wrought Stainless Steels for Surgical Instruments
F1744 Guide for Care and Handling of Stainless Steel Surgical Instruments
ISO StandardsISO10664 Hexalobular Internal Driving Feature for Bolts and Screws
ICS Number Code 11.040.30 (Surgical instruments and materials)