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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 11-309
Standard
ASTM  F116-12 (Reapproved 2016)
Standard Specification for Medical Screwdriver Bits
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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