ASTM F116-12(2021) - 1.2.2021
 
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, 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.

 
2. Referenced Documents

E18-25

Standard Test Methods for Rockwell Hardness of Metallic Materials

F543-23

Standard Specification and Test Methods for Metallic Medical Bone Screws

F90-24

Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F565-26

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

F899-23

Standard Specification for Wrought Stainless Steels for Surgical Instruments

F1744-96(2024)

Standard Guide for Care and Handling of Stainless Steel Surgical Instruments