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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
01/30/2014 Dental/
ENT		 4-151 Complete ISO 22112 First edition 2005-11-01 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2008 (R2013) Artificial Teeth for Dental Prostheses
01/30/2014 Dental/
ENT		 4-153 Complete ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
07/09/2014 Dental/
ENT		 4-160 Complete ANSI ASA S3.1-1999 (Reaffirmed 2023) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
01/14/2019 Dental/
ENT		 4-162 Complete ANSI ASA S3.4-2007 (Reaffirmed 2020) American National Standard Procedure for the Computation of Loudness of Steady Sounds
01/14/2019 Dental/
ENT		 4-163 Complete ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
07/09/2014 Dental/
ENT		 4-165 Complete ANSI ASA S3.13-1987 (Reaffirmed 2020) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
08/06/2013 Dental/
ENT		 4-167 Complete ANSI ASA S3.21-2004 (Reaffirmed 2019) American National Standard Methods for Manual Pure-Tone Threshold Audiometry
01/14/2019 Dental/
ENT		 4-171 Complete ANSI ASA S3.37-1987 (Reaffirmed 2020) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
03/16/2012 Dental/
ENT		 4-173 Complete ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
07/09/2014 Dental/
ENT		 4-177 Complete ANSI ASA S12.65-2006 (Reaffirmed 2020) American National Standard For Rating Noise with Respect to Speech Interference
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