Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
056
|
Date of Entry 06/07/2021
|
FR Recognition Number
|
4-273
|
Standard | |
ANSI ASA S3.7-2016 (Reaffirmed 2023) American National Standard Method for Coupler Calibration of Earphones |
|
Scope/AbstractThis standard describes measurement methods for earphones and earphone transducers using couplers or ear simulators. Guidance is provided for the selection of the appropriate coupler or ear simulator for a given earphone and application. Methods for measurement of calibrated frequency response, input-output linearity, electrical impedance, and non-linear distortion, are described. |
|
Extent of Recognition
|
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 |
§874.1050 |
Audiometer
|
Class 2
|
EWO
|
§874.1080 |
Set, Audiometer Calibration
|
Class 1
|
EWA
|
|
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
|
Standards Development Organizations
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |