ASTM F116-12(2021) PDF

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, 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 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 F116-12(2021) 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 5832-5 Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel*， 2022-03-18 Update
ISO 5835 Implants for surgery; metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread; dimensions
ISO 7153-1 Surgical instruments - Materials - Part 1: Metals
ISO 8319-1 Orthopaedic instruments - Drive connections - Part 1: Keys for use with screws with hexagon socket heads
ISO 8319-2 Orthopaedic instruments; Drive connections; Part 2 : Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
ISO 9268 Implants for surgery; metal bone screws with conical under-surface of head; dimensions