|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 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 |
| 01/30/2014 |
Dental/
ENT |
4-199 |
ISO |
6876 Third edition 2012-06-01 |
Dentistry -- Root canal sealing materials |
| 06/27/2016 |
Dental/
ENT |
4-202 |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
| 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) |
| 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 |
| 08/21/2017 |
Dental/
ENT |
4-215 |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
| 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 |
4-218 |
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 |
| 01/27/2015 |
Dental/
ENT |
4-219 |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 08/14/2015 |
Dental/
ENT |
4-220 |
ANSI ASA |
S3.22-2014 (Reaffirmed 2020) |
American National Standard Specification of Hearing Aid Characteristics |
| 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 |
| 04/04/2016 |
Dental/
ENT |
4-222 |
ISO |
6874 Third edition 2015-09-01 |
Dentistry - Polymer-based pit and fissure sealants |
| 04/04/2016 |
Dental/
ENT |
4-224 |
ISO |
24234 Second edition 2015-05-01 |
Dentistry - Dental Amalgam |
| 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 |
| 06/27/2016 |
Dental/
ENT |
4-228 |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
| 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 |
| 08/21/2017 |
Dental/
ENT |
4-232 |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
| 08/21/2017 |
Dental/
ENT |
4-233 |
ISO |
20795-2 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 08/21/2017 |
Dental/
ENT |
4-234 |
ANSI ADA |
Standard No. 139-2012 |
Dental Base Polymers |
| 08/21/2017 |
Dental/
ENT |
4-236 |
ANSI ADA |
Standard No. 119-2015 |
Manual Toothbrushes |
| 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 |
| 08/21/2017 |
Dental/
ENT |
4-239 |
ANSI AAMI |
CI86:2017 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 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 |
| 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 |
| 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 |
| 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 |
4-246 |
ANSI ADA |
Standard No. 144-2018 |
Alloy for Dental Amalgam |
| ISO |
20749 First edition 2017-03 |
Dentistry - Pre-capsulated dental amalgam |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-248 |
ISO |
10477 Third edition 2018-06 |
Dentistry - Polymer-based crown and veneering materials |
| 01/14/2019 |
Dental/
ENT |
4-249 |
ANSI ADA |
Standard No. 19-2018 |
Elastometric Impression Materials |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-252 |
ANSI ADA |
Standard No. 48-2020 |
Curing Lights (Powered Polymerization Activators) |
| ISO |
10650 Second edition 2018-08 |
Dentistry - Powered polymerization activators |
| 01/14/2019 |
Dental/
ENT |
4-253 |
ANSI ADA |
Standard No. 27-2016 |
Polymer-based Restorative Materials |
| 01/14/2019 |
Dental/
ENT |
4-254 |
ANSI ADA |
Standard No. 99-2001 (R2013) |
Athletic Mouth Protectors and 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 |
4-256 |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 01/14/2019 |
Dental/
ENT |
4-257 |
ISO |
17730 First edition 2014-11-01 |
Dentistry - Fluoride varnishes |
| 07/15/2019 |
Dental/
ENT |
4-258 |
ANSI ADA |
Standard No. 160-2020 |
Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use |
| ISO |
10139-2 Third edition 2016-06-15 |
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
| 07/15/2019 |
Dental/
ENT |
4-259 |
ANSI ADA |
Standard No. 127-2018 |
Dynamic Loading Test for Endosseous Dental Implants |
| ISO |
14801 Third edition 2016-11-01 |
Dentistry - Implants - Dynamic loading test for endosseous dental implants |
| 12/23/2019 |
Dental/
ENT |
4-260 |
ANSI ASA |
S12.2-2019 |
American National Standard Criteria for Evaluating Room Noise |
| 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 |
| 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 |
| 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 |
| 12/21/2020 |
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 |
| 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 |
| 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 |
| 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)] |
| 12/21/2020 |
Dental/
ENT |
4-269 |
ISO |
3964 Third edition 11-2016 |
Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| 12/21/2020 |
Dental/
ENT |
4-270 |
ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
| 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 |
| 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 |
4-274 |
ANSI ASA |
S3.2-2020 |
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
| 06/07/2021 |
Dental/
ENT |
4-275 |
ANSI ASA |
S3.6-2018 |
American National Standard Specification for Audiometers |
| 06/07/2021 |
Dental/
ENT |
4-276 |
ANSI ADA |
Standard No. 35-2019 |
Dental Handpieces and Motors |
| ISO |
14457 Second edition 2017-10 |
Dentistry - Handpieces and motors |
| 06/07/2021 |
Dental/
ENT |
4-277 |
ANSI IEEE |
C63.19-2019 |
American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids |
| 06/07/2021 |
Dental/
ENT |
4-278 |
ANSI ADA |
Standard No. 19-2022 |
Elastomeric Impression and Bite Registration |
| ISO |
4823 Fifth edition 2021-02 |
Dentistry - Elastomeric impression and bite registration materials |
| 06/07/2021 |
Dental/
ENT |
4-279 |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
| 06/07/2021 |
Dental/
ENT |
4-280 |
ANSI ADA |
Standard No. 117-2018 |
Fluoride varnishes |
| 06/07/2021 |
Dental/
ENT |
4-281 |
ANSI ADA |
Standard No. 179-2020 |
Shanks for Rotary and Oscillating Instruments |
| ISO |
1797 Third Edition 2017-05 |
Dentistry - Shanks for rotary and oscillating instruments |
| 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 |
| 12/20/2021 |
Dental/
ENT |
4-284 |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
| 12/20/2021 |
Dental/
ENT |
4-285 |
ANSI ADA |
Standard No. 37-1986 (R2020) |
Dental Abrasive Powders |
| 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) |
| 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 |
| 12/20/2021 |
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 |
| 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 |
| 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 |
| 05/30/2022 |
Dental/
ENT |
4-293 |
ANSI ADA |
Standard No. 119-2021 |
Manual Toothbrushes |
| 12/19/2022 |
Dental/
ENT |
4-294 |
ANSI ADA |
Standard No. 139-2020 |
Dental Base Polymers |
| 12/19/2022 |
Dental/
ENT |
4-295 |
ANSI ADA |
Standard No. 41-2020 |
Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 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 |
| 12/19/2022 |
Dental/
ENT |
4-297 |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual toothbrushes - General requirements and test methods |
| 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 |
| 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 |
| 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 |
| 06/27/2016 |
General I (QS/
RM) |
5-57 |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
| 01/27/2015 |
General I (QS/
RM) |
5-62 |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
| 08/06/2013 |
General I (QS/
RM) |
5-76 |
ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 |
Medical Electrical Equipment ¿ Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. |
| IEC |
60601-1-8 Edition 2.1 2012-11 |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 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 |
| 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)] |
| 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 |
| 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 |
| 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) |
| 04/04/2016 |
General I (QS/
RM) |
5-99 |
ASTM |
D4332-14 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 06/15/2016 |
General I (QS/
RM) |
5-102 |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
| 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 |
| 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)] |
| 06/27/2016 |
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. |
| 12/23/2016 |
General I (QS/
RM) |
5-113 |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
| 12/23/2016 |
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)] |
| 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) |
| 01/14/2019 |
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 |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 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) |
5-124 |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
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