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, ISO 8319–2, and ISO 10664.
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.
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 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.
ASTM F116-12(2016) Referenced Document
ASTM E18 Standard Test Methods for Rockwell Hardness of Metallic Materials*, 2022-05-01 Update
ASTM F1744 Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments*, 2021-04-01 Update
ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments
ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
ISO 10664 Hexalobular internal driving feature for bolts and screws
ISO 5835 Implants for surgery; metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread; dimensions
ISO 9268 Implants for surgery; metal bone screws with conical under-surface of head; dimensions
ASTM F116-12(2016) history
2021ASTM F116-12(2021) Standard Specification for Medical Screwdriver Bits
2016ASTM F116-12(2016) Standard Specification for Medical Screwdriver Bits
2012ASTM F116-12 Standard Specification for Medical Screwdriver Bits
2000ASTM F116-00(2009) Standard Specification for Medical Screwdriver Bits
2000ASTM F116-00(2004) Standard Specification for Medical Screwdriver Bits
2000ASTM F116-00 Standard Specification for Medical Screwdriver Bits