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  • ASTM
    F116-12 Standard Specification for Medical Screwdriver Bits
    Edition: 2012
    $91.10
    Unlimited Users per year

Description of ASTM-F116 2012

ASTM F116 - 12

Standard Specification for Medical Screwdriver Bits

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

Book of Standards Volume: 13.01




ASTM F116

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 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.

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 83191 , ISO 83192 , 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

Keywords

bone screw; orthopaedic medical devices; screwdriver; surgical instruments;


ICS Code

ICS Number Code 11.040.30 (Surgical instruments and materials)


DOI: 10.1520/F0116-12

ASTM International is a member of CrossRef.

ASTM F116

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