ASTM F116 - 12

    Standard Specification for Medical Screwdriver Bits

    Active Standard ASTM F116 | Developed by Subcommittee: F04.21

    Book of Standards Volume: 13.01


      Format Pages Price  
    PDF 4 $38.00   ADD TO CART
    Hardcopy (shipping and handling) 4 $38.00   ADD TO CART
    Standard + Redline PDF Bundle 8 $45.60   ADD TO CART


    Abstract

    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 Isingle-slot bit; Type IIcruciate-slot bit; Type IIIcross-slot (modified Phillips) bit; Type IVhexagonal bit; Type Vsquare bit; Type VIhexalobe 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.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    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 and health practices and determine the applicability of regulatory limitations prior to use.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    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 Standards

    ISO10664 Hexalobular Internal Driving Feature for Bolts and Screws


    ICS Code

    ICS Number Code 11.040.30 (Surgical instruments and materials)

    UNSPSC Code

    UNSPSC Code 42295139(Instrument rolls for surgical instruments or accessories)


    Referencing This Standard

    DOI: 10.1520/F0116-12

    ASTM International is a member of CrossRef.

    Citation Format

    ASTM F116-12, Standard Specification for Medical Screwdriver Bits, ASTM International, West Conshohocken, PA, 2012, www.astm.org

    Back to Top