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ASTM F116-12(2016)

ASTM F116-12(2016)

Standard Specification for Medical Screwdriver Bits

Fecha:
2021-02-10 /Historical
Superseeded by:
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.

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.

Keywords:
bone screw; orthopaedic medical devices; screwdriver; surgical instruments;
48,12
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