| ANSI ASA S3.36-2012 (Reaffirmed 2018) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements |
| Recognition Number | Dental/ENT |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 4-217 |
| Extent | Complete standard |
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| STG | Dental/ENT |
| FDA Tech | Shu-Chen Peng FDA/OMPT/CDRH/ODE/DOED/ENTB/ 301-796-6481 shu-chen.peng@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §874.3300 | Hearing Aid, Air Conduction | Class 1 | ESD |
| There is no relevant guidance developed at this time. |