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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 036 Date of Entry 07/09/2014 
FR Recognition Number 4-165
Standard
ANSI ASA  S3.13-1987 (Reaffirmed 2020)
American National Standard Mechanical Coupler for Measurement of Bone Vibrators
Scope/Abstract
This standard specifies requirements for mechanical couplers used for calibrating bone-conduction audi-meters and for making measurements on bone vibrators and bone-conduction hearing aids, in the frequency range from 125 to 8000 hertz (Hz) inclusive.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§874.3302 Hearing Aid, Bone Conduction Class 2 LXB
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
 Vasant Dasika
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB
  301-796-5365
  Vasant.Dasika@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ASA Acoustical Society of America http://acousticalsociety.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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