|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 12/20/2021 |
Dental/
ENT |
4-286 |
ANSI ADA |
Standard No. 87-1995 (R2014) |
Dental Impression Trays |
| 08/06/2013 |
Dental/
ENT |
4-167 |
ANSI ASA |
S3.21-2004 (Reaffirmed 2019) |
American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
| 01/14/2019 |
Dental/
ENT |
4-254 |
ANSI ADA |
Standard No. 99-2001 (R2013) |
Athletic Mouth Protectors and Materials |
| 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) |
| 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 |
| 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 |
| 12/20/2021 |
Dental/
ENT |
4-285 |
ANSI ADA |
Standard No. 37-1986 (R2020) |
Dental Abrasive Powders |
| 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 |
| 08/14/2015 |
Dental/
ENT |
4-130 |
ANSI ADA |
Standard No. 17-1983 (R2014) |
Denture Base Temporary Relining Resins |
| 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 |
| 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 |
| 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 |
| 01/27/2015 |
Dental/
ENT |
4-219 |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 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 |
| 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 |
| 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 |
4-137 |
ANSI ADA |
Standard No. 78-2013 |
Dental obturating cones |
| ISO |
6877 Second edition 2006-04-01 |
Dentistry - Root-canal obturating points |
| 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 |
4-177 |
ANSI ASA |
S12.65-2006 (Reaffirmed 2020) |
American National Standard For Rating Noise with Respect to Speech Interference |
| 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) |
| 07/09/2014 |
Dental/
ENT |
4-97 |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
| 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 |
| 12/19/2022 |
Dental/
ENT |
4-297 |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual 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 |
| 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) |
| 01/27/2015 |
Dental/
ENT |
4-185 |
ANSI ASA |
S3.45-2009 (Reaffirmed 2019) |
American National Standard Procedures for Testing Basic Vestibular Function |
| 08/21/2017 |
Dental/
ENT |
4-232 |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-248 |
ISO |
10477 Third edition 2018-06 |
Dentistry - Polymer-based crown and veneering materials |
| 08/21/2017 |
Dental/
ENT |
4-233 |
ISO |
20795-2 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 12/21/2020 |
Dental/
ENT |
4-266 |
ANSI ADA |
Standard No. 178-2019 |
Orthodontic Anchor Screws |
| ISO |
19023 First edition 2018-02 |
Dentistry - Orthodontic anchor screws |
| 08/21/2017 |
Dental/
ENT |
4-239 |
ANSI AAMI |
CI86:2017 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 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 |
| 01/30/2014 |
Dental/
ENT |
4-181 |
ISO |
4049 Fourth edition 2009-10-01 |
Dentistry - Polymer-based restorative materials |
| 04/04/2016 |
Dental/
ENT |
4-224 |
ISO |
24234 Second edition 2015-05-01 |
Dentistry - Dental Amalgam |
| 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 |
| 08/14/2015 |
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 |
4-231 |
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 |
| 12/23/2019 |
Dental/
ENT |
4-260 |
ANSI ASA |
S12.2-2019 |
American National Standard Criteria for Evaluating Room Noise |
| 09/17/2018 |
Dental/
ENT |
4-244 |
ISO |
8325 Second edition 2004-09-15 |
Dentistry - Test methods for rotary instruments |
| 12/21/2020 |
Dental/
ENT |
4-269 |
ISO |
3964 Third edition 11-2016 |
Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| 06/27/2016 |
Dental/
ENT |
4-228 |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
| 06/27/2016 |
Dental/
ENT |
4-202 |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
| 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 |
| 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 |
| 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 |
| 07/09/2014 |
Dental/
ENT |
4-165 |
ANSI ASA |
S3.13-1987 (Reaffirmed 2020) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 01/14/2019 |
Dental/
ENT |
4-163 |
ANSI ASA |
S3.5-1997 (Reaffirmed 2020) |
American National Standard Methods for Calculation of the Speech Intelligibility Index |
| 12/21/2020 |
Dental/
ENT |
4-268 |
ANSI ADA |
Standard No. 32-2017 |
Orthodontic Wires |
| ISO |
15841 Second edition 2014-08 |
Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] |
| 06/27/2016 |
Dental/
ENT |
4-139 |
ANSI ADA |
Standard No. 48-2004 (R2015) |
Visible Light Curing Units |
| 12/19/2022 |
Dental/
ENT |
4-296 |
ANSI ADA |
Standard No. 191-2020 |
Intra-Oral Mirrors |
| ISO |
9873 Fourth edition 2019-03 |
Dentistry - Intra-oral mirrors |
| 12/20/2021 |
Dental/
ENT |
4-284 |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
| 07/06/2020 |
Dental/
ENT |
4-263 |
ANSI ADA |
Standard No. 38-2020 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| ISO |
9693 Third edition 2019-10 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| 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 |
| 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 |
| 08/21/2017 |
Dental/
ENT |
4-215 |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
| 06/07/2021 |
Dental/
ENT |
4-273 |
ANSI ASA |
S3.7-2016 (Reaffirmed 2020) |
American National Standard Method for Coupler Calibration of Earphones |
| 06/07/2021 |
Dental/
ENT |
4-275 |
ANSI ASA |
S3.6-2018 |
American National Standard Specification for Audiometers |
| 12/21/2020 |
Dental/
ENT |
4-270 |
ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
| 01/14/2019 |
Dental/
ENT |
4-249 |
ANSI ADA |
Standard No. 19-2018 |
Elastometric Impression Materials |
| 01/14/2019 |
Dental/
ENT |
4-255 |
ANSI ADA |
Standard No. 131-2015 |
Dental CAD/CAM Machinable Zirconia Blanks |
| 01/14/2019 |
Dental/
ENT |
4-162 |
ANSI ASA |
S3.4-2007 (Reaffirmed 2017) |
American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| 12/23/2019 |
Dental/
ENT |
4-261 |
ISO |
7405 Third edition 2018-10 Corrected version 2018-12 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| 12/23/2019 |
Dental/
ENT |
4-262 |
IEC |
80601-2-60 Edition 2.0 2019-06 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| 01/14/2019 |
Dental/
ENT |
4-250 |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 01/14/2019 |
Dental/
ENT |
4-251 |
ANSI ADA |
Standard No. 69-2020 |
Dental Ceramic |
| ISO |
6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] |
Dentistry - Ceramic materials |
| 12/21/2020 |
Dental/
ENT |
4-267 |
ANSI ADA |
Standard No. 105-2010 (R2015) |
Orthodontic Elastomeric Materials |
| ISO |
21606 First edition 2007-06 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
| 01/14/2019 |
Dental/
ENT |
4-256 |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 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 |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 06/27/2016 |
General I (QS/
RM) |
5-89 |
IEC |
60601-1-6 Edition 3.1 2013-10 |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 07/06/2020 |
General I (QS/
RM) |
5-127 |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
| 07/06/2020 |
General I (QS/
RM) |
5-128 |
ISTA |
3E 2017 |
Similar Packaged-Products in Unitized Loads of Truckload Shipment |
| 07/06/2020 |
General I (QS/
RM) |
5-126 |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
| 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)]. |
| 12/23/2019 |
General I (QS/
RM) |
5-125 |
ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
| ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
| 07/06/2020 |
General I (QS/
RM) |
5-129 |
ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
| 12/23/2016 |
General I (QS/
RM) |
5-114 |
ANSI AAMI IEC |
|
Standard |
| IEC |
62366-1 Edition 1.0 2015-02 |
Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] |
| 12/23/2019 |
General I (QS/
RM) |
5-124 |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
| 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 |
| 01/14/2019 |
General I (QS/
RM) |
5-121 |
ISO |
80369-1 Second edition 2018-11 |
Small-bore connectors for liquids and gases in healthcare applications - 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 |
| 08/14/2015 |
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 |
| 01/27/2015 |
General I (QS/
RM) |
5-62 |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
| 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 |
| 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)] |
| 12/23/2016 |
General I (QS/
RM) |
5-113 |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 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) |
| 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) |
| 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 |
| 06/15/2016 |
General I (QS/
RM) |
5-102 |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
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