ANSI S3.13-1987 (Reaffirmed 2012)

Standard Organization:

ANSI S3.13-1987 (Reaffirmed 2012)
American National Standard Mechanical Coupler for Measurement of Bone Vibrators

• Recognition Date: 2014-07-09
• Recognition List: 036
• Recognition Number: 4-165
• Extent: Complete standard
• Standards Orgs: ANSI American National Standards Institute https://www.ansi.org/
• STG: Dental/ENT
• FDA Tech: Vasant Dasika FDA/OMPT/CDRH/ODE/DOED/ENTB/ 301-796-5365 vasant.dasika@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§874.3300	Hearing Aid, Bone Conduction	Class 2	LXB

FDA Guidance:

There is no relevant guidance developed at this time.