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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 051 Date of Entry 01/14/2019 
FR Recognition Number 4-217
ANSI ASA  S3.36-2012 (Reaffirmed 2022)
American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
This standard describes a manikin which is intended to simulate the acoustical effects of a median human adult, including diffractions affecting the in-situ performance of electroacoustic devices used on or near a person. The manikin consists of a head mounted on a torso that extends to the waist. The head is equipped with pinnae and ear simulators with acoustic impedance terminations and microphones located at positions corresponding to those of eardrums on a median human adult. Measurement results obtained with the manikin may differ substantially from similar results obtained on an individual person due to anatomical variations. Median dimensions provided in the annexes were drawn from the population samples described in the Bibliography.

The manikin is described by the acoustical performance requirements of this standard. Physical dimensions of manikins that meet these requirements are provided for information but are not part of the standard. Dimensional information can be found in Annexes B, C and D.

For test application specific requirements, the user is referred to clause 8 for additional information, pertinent test standards, and/or any modifications to the basic specifications required for that particular application.

Manikins for binaural recording are outside the scope of this standard.
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
§874.3300 Hearing Aid, Air-Conduction, Prescription Class 1 ESD
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 Contacts
 Julie Cohen
 Vasant Dasika
 Lindsay DeVries
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)
*These are provided as examples and others may be applicable.