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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Number and Date
 

Title of Standard
 
 
01/27/2015 Dental/
ENT
4-218 ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
08/21/2017 Dental/
ENT
4-238 ANSI ADA Standard No.120-2009 (R2014) Powered Toothbrushes
ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods
01/30/2014 Dental/
ENT
4-199 ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
04/04/2016 Dental/
ENT
4-221 ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
12/20/2021 Dental/
ENT
4-292 ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
ISO 28888 First edition 2013-10 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
01/14/2019 Dental/
ENT
4-217 ANSI ASA S3.36-2012 (Reaffirmed 2018) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
01/27/2015 Dental/
ENT
4-219 ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
08/06/2013 Dental/
ENT
4-204 ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
01/30/2014 Dental/
ENT
4-151 ANSI ADA Standard No. 15-2008 (R2013) Artificial Teeth for Dental Prostheses
ISO 22112 First edition 2005-11-01 Dentistry - Artificial teeth for dental prostheses
12/21/2020 Dental/
ENT
4-264 ANSI ADA Standard No. 88-2019 Dental Brazing Alloys
ISO 9333 Second edition 2006-07 Dentistry - Brazing materials
04/04/2016 Dental/
ENT
4-222 ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
06/07/2018 Dental/
ENT
4-241 ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
08/06/2013 Dental/
ENT
4-90 ANSI ASA S3.39:1987 (Reaffirmed 2020) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
09/17/2018 Dental/
ENT
4-246 ANSI ADA Standard No. 144-2018 Alloy for Dental Amalgam
ISO 20749 First edition 2017-03 Dentistry - Pre-capsulated dental amalgam
07/09/2014 Dental/
ENT
4-97 ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
04/04/2016 Dental/
ENT
4-224 ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
08/21/2017 Dental/
ENT
4-232 ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
07/09/2014 Dental/
ENT
4-165 ANSI ASA S3.13-1987 (Reaffirmed 2020) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
08/14/2015 Dental/
ENT
4-130 ANSI ADA Standard No. 17-1983 (R2014) Denture Base Temporary Relining Resins
01/27/2015 Dental/
ENT
4-136 ASTM F2504-05 (Reapproved 2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
07/09/2014 Dental/
ENT
4-160 ANSI ASA S3.1-1999 (Reaffirmed 2018) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
01/30/2014 Dental/
ENT
4-153 ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
01/30/2014 Dental/
ENT
4-180 ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
01/30/2014 Dental/
ENT
4-188 ISO 9917-2 Second edition 2010-04-15 Dentistry - Water-based cements - Part 2: Resin-modified cements
08/06/2013 Dental/
ENT
4-167 ANSI ASA S3.21-2004 (Reaffirmed 2019) American National Standard Methods for Manual Pure-Tone Threshold Audiometry
12/20/2021 Dental/
ENT
4-291 ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
01/30/2014 Dental/
ENT
4-198 ANSI ADA Standard No.30-2013 (R2018) Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol Cements
ISO 3107 Fourth edition 2011-03-01 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
12/20/2021 Dental/
ENT
4-285 ANSI ADA Standard No. 37-1986 (R2020) Dental Abrasive Powders
06/27/2016 Dental/
ENT
4-228 ANSI ASA S3.20-2015 (Reaffirmed 2020) American National Standard Bioacoustical Terminology
01/14/2019 Dental/
ENT
4-254 ANSI ADA Standard No. 99-2001 (R2013) Athletic Mouth Protectors and Materials
06/07/2021 Dental/
ENT
4-283 ANSI ADA Standard No. 125-2018 Manual Interdental Brushes
ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
01/30/2014 Dental/
ENT
4-137 ANSI ADA Standard No. 78-2013 Dental obturating cones
ISO 6877 Second edition 2006-04-01 Dentistry - Root-canal obturating points
06/07/2021 Dental/
ENT
4-274 ANSI ASA S3.2-2020 American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
07/09/2014 Dental/
ENT
4-177 ANSI ASA S12.65-2006 (Reaffirmed 2020) American National Standard For Rating Noise with Respect to Speech Interference
03/16/2012 Dental/
ENT
4-173 ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
06/27/2016 Dental/
ENT
4-202 ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
06/07/2021 Dental/
ENT
4-282 ANSI ADA Standard No. 135-2015 Denture Adhesives
ISO 10873 First edition 2010-09 Dentistry - Denture adhesives
12/20/2021 Dental/
ENT
4-286 ANSI ADA Standard No. 87-1995 (R2014) Dental Impression Trays
12/20/2021 Dental/
ENT
4-287 ANSI ADA Standard No. 116-2020 Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
08/21/2017 Dental/
ENT
4-231 ANSI ADA Standard No. 111-2019 Adhesion Test Methods to Tooth Structure
ISO /TS 11405 Third edition 2015-02-01 Dentistry - Testing of adhesion to tooth structure
12/20/2021 Dental/
ENT
4-289 ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
12/20/2021 Dental/
ENT
4-290 ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
01/14/2019 Dental/
ENT
4-248 ISO 10477 Third edition 2018-06 Dentistry - Polymer-based crown and veneering materials
01/14/2019 Dental/
ENT
4-171 ANSI ASA S3.37-1987 (Reaffirmed 2020) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
12/20/2021 Dental/
ENT
4-284 ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
08/21/2017 Dental/
ENT
4-233 ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
12/20/2021 Dental/
ENT
4-288 ANSI ADA Standard No. 43-2020 Electrically Powered Dental Amalgamators
ISO 7488 Second edition 2018-04 Dentistry - Mixing machines for dental amalgam
05/30/2022 Dental/
ENT
4-293 ANSI ADA Standard No. 119-2021 Manual Toothbrushes
08/21/2017 Dental/
ENT
4-236 ANSI ADA Standard No. 119-2015 Manual Toothbrushes
06/07/2018 Dental/
ENT
4-240 ANSI ADA Standard No. 128-2015 Hydrocolloid Impression Materials
ISO 21563 First edition 2013-08-15 Dentistry - Hydrocolloid impression materials
08/21/2017 Dental/
ENT
4-215 ANSI ADA Standard No. 96-2012 Dental Water-based Cements
12/21/2020 Dental/
ENT
4-269 ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
06/07/2021 Dental/
ENT
4-279 ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT
4-281 ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
06/07/2021 Dental/
ENT
4-278 ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
08/21/2017 Dental/
ENT
4-234 ANSI ADA Standard No. 139-2012 Dental Base Polymers
12/21/2020 Dental/
ENT
4-271 ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
12/21/2020 Dental/
ENT
4-272 ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
12/21/2020 Dental/
ENT
4-265 ANSI ADA Standard No. 97-2020 Corrosion Test Methods for Metallic Materials
ISO 10271 Third edition 2020-08 Dentistry - Corrosion test methods for metallic materials
09/17/2018 Dental/
ENT
4-244 ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments
09/17/2018 Dental/
ENT
4-242 ANSI ADA Standard No. 75-2020 Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
ISO 10139-1 Third edition 2018-03 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
12/21/2020 Dental/
ENT
4-270 ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
07/06/2020 Dental/
ENT
4-263 ISO 9693 Third edition 2019-10 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
08/14/2015 Dental/
ENT
4-220 ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/14/2015 Dental/
ENT
4-184 ANSI ASA S3.25-2009 (Reaffirmed 2019) American National Standard For an Occluded Ear Simulator
09/09/2008 Dental/
ENT
4-145 ISO 22803 First edition 2004-09-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
08/21/2017 Dental/
ENT
4-239 ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01/30/2014 Dental/
ENT
4-181 ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
07/09/2014 Dental/
ENT
4-149 ANSI ADA Standard No. 39-2006 (R2011) Pit and Fissure Sealants
06/27/2016 Dental/
ENT
4-86 ANSI ADA Standard No. 38-2000 (R2015) Metal-Ceramic Dental Restorative Systems
06/27/2016 Dental/
ENT
4-227 ANSI ADA Standard No. 134-2018 Metallic Materials for Fixed and Removable Restorations and Appliances
ISO 22674 Second edition 2016-01-15 Dentistry - Metallic materials for fixed and removable restorations and appliances
04/04/2016 Dental/
ENT
4-190 ANSI ASA S3.35-2010 (Reaffirmed 2020) American National Standard Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
09/17/2018 Dental/
ENT
4-247 ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
01/27/2015 Dental/
ENT
4-185 ANSI ASA S3.45-2009 (Reaffirmed 2019) American National Standard Procedures for Testing Basic Vestibular Function
07/09/2014 Dental/
ENT
4-211 ANSI ASA S3.46-2013 (Reaffirmed 2018) American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
12/23/2016 General I (QS/
RM)
5-113 ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
12/23/2019 General I (QS/
RM)
5-124 ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols
07/09/2014 General I (QS/
RM)
5-88 ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
01/30/2014 General I (QS/
RM)
5-84 AAMI TIR 49:2013/(R)2020 Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
09/17/2018 General I (QS/
RM)
5-118 AAMI TIR66: 2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
06/15/2016 General I (QS/
RM)
5-104 IEC /TR 60878 Ed. 3.0 b:2015 Graphical symbols for electrical equipment in medical practice
09/17/2018 General I (QS/
RM)
5-119 ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
09/17/2018 General I (QS/
RM)
5-42 ASTM D903-98 (Reapproved 2017) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
12/21/2020 General I (QS/
RM)
5-133 ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
07/06/2020 General I (QS/
RM)
5-130 ISO 7010 Third edition 2019-07 Graphical symbols - Safety colours and safety signs - Registered safety signs
04/04/2016 General I (QS/
RM)
5-99 ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
01/27/2015 General I (QS/
RM)
5-62 ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
04/04/2016 General I (QS/
RM)
5-98 ANSI ESD S20.20-2014 Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
08/21/2017 General I (QS/
RM)
5-117 ANSI AAMI ISO 15223-1:2016 Medical devices - Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements
ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
08/14/2015 General I (QS/
RM)
5-97 ANSI AAMI ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
12/20/2021 General I (QS/
RM)
5-134 ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
01/27/2015 General I (QS/
RM)
5-48 ANSI Z1.9-2003 (R2018) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
08/21/2017 General I (QS/
RM)
5-107 ANSI AAMI ISO 80369-5 : 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.
IEC 80369-5: Edition 1.0 2016-03 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)]
06/15/2016 General I (QS/
RM)
5-102 IEC 60417:2002 DB Graphical symbols for use on equipment
06/27/2016 General I (QS/
RM)
5-108 ISO 80369-6 First Edition 2016-03-15 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
02/07/2022 General I (QS/
RM)
15-135 ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
01/30/2014 General I (QS/
RM)
5-47 ISO 10012 First edition 2003-01-15 Measurement management systems - Requirements for measurement processes and measuring equipment
07/15/2019 General I (QS/
RM)
5-123 ISO 80369-3 First Edition 2016-07-01 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
01/14/2019 General I (QS/
RM)
5-120 IEC 60812 Edition 3.0 2018-08 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
12/23/2016 General I (QS/
RM)
5-114 ANSI AAMI IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
 
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