|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
08/21/2017 |
Dental/ ENT |
4-215 |
Complete |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
06/27/2016 |
Dental/ ENT |
4-228 |
Complete |
ANSI ASA |
S3.20-2015 (Reaffirmed 2020) |
American National Standard Bioacoustical Terminology |
06/27/2016 |
Dental/ ENT |
4-202 |
Complete |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
12/18/2023 |
Dental/ ENT |
4-320 |
Complete |
ISO |
13402 First edition 1995-08-01 |
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
01/27/2015 |
Dental/ ENT |
4-218 |
Complete |
ISO |
27020 First edition 2010-12-15 |
Dentistry - Brackets and tubes for use in orthodontics |
ANSI ADA |
Standard No.100-2012 |
Orthodontic Brackets and Tubes |
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 |
01/27/2015 |
Dental/ ENT |
4-136 |
Complete |
ASTM |
F2504-05 (Reapproved 2022) |
Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices |
07/09/2014 |
Dental/ ENT |
4-149 |
Complete |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
12/18/2023 |
Dental/ ENT |
4-313 |
Complete |
ISO |
27020 Second edition 2019-06 |
Dentistry - Brackets and tubes for use in orthodontics |
ANSI ADA |
Standard No.100-2020 |
Orthodontic Brackets and Tubes |
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 |
08/14/2015 |
Dental/ ENT |
4-220 |
Complete |
ANSI ASA |
S3.22-2014 (Reaffirmed 2020) |
American National Standard Specification of Hearing Aid Characteristics |
08/14/2015 |
Dental/ ENT |
4-184 |
Complete |
ANSI ASA |
S3.25-2009 (Reaffirmed 2024) |
American National Standard For an Occluded Ear Simulator |
08/06/2013 |
Dental/ ENT |
4-90 |
Complete |
ANSI ASA |
S3.39:1987 (Reaffirmed 2020) |
American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) |
08/06/2013 |
Dental/ ENT |
4-204 |
Complete |
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) |
08/21/2017 |
Dental/ ENT |
4-232 |
Complete |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
01/27/2015 |
Dental/ ENT |
4-185 |
Complete |
ANSI ASA |
S3.45-2009 (Reaffirmed 2024) |
American National Standard Procedures for Testing Basic Vestibular Function |
06/07/2018 |
Dental/ ENT |
4-241 |
Complete |
ISO |
7491 Second edition 2000-09-01 |
Dental materials - Determination of colour stability |
ANSI ADA |
Standard No. 80-2001 (R2020) |
Dental Materials-Determination of Color Stability |
08/06/2013 |
Dental/ ENT |
4-167 |
Complete |
ANSI ASA |
S3.21-2004 (Reaffirmed 2023) |
American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
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 |
09/17/2018 |
Dental/ ENT |
4-247 |
Complete |
ISO |
28319 Second edition 2018-04 |
Dentistry - Laser welding and filler materials |
ANSI ADA |
Standard No. 84-2020 |
Laser Welding and Filler Materials in Dentistry |
12/19/2022 |
Dental/ ENT |
4-295 |
Complete |
ANSI ADA |
Standard No. 41-2020 |
Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
12/23/2024 |
Dental/ ENT |
4-334 |
Complete |
ISO |
11143 Second edition 2008-07 |
Dentistry - Amalgam separators |
ANSI ADA |
Standard No. 108-2009, Addendum (R2022) |
Amalgam Separators |
09/17/2018 |
Dental/ ENT |
4-242 |
Complete |
ISO |
10139-1 Third edition 2018-03 |
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use |
ANSI ADA |
Standard No. 75-2020 |
Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials |
05/29/2023 |
Dental/ ENT |
4-303 |
Complete |
ISO |
9333 Third edition 2022-08 |
Dentistry - Brazing materials |
12/21/2020 |
Dental/ ENT |
4-264 |
Complete |
ISO |
9333 Second edition 2006-07 |
Dentistry - Brazing materials |
ANSI ADA |
Standard No. 88-2019 |
Dental Brazing Alloys |
05/29/2023 |
Dental/ ENT |
4-304 |
Complete |
ISO |
21606 Second edition 2022-08 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
12/21/2020 |
Dental/ ENT |
4-267 |
Complete |
ISO |
21606 First edition 2007-06 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
ANSI ADA |
Standard No. 105-2010 (R2015) |
Orthodontic Elastomeric Materials |
12/23/2024 |
Dental/ ENT |
4-328 |
Complete |
ANSI ADA |
Standard No. 57-2021 |
Endodontic Sealing Materials |
07/06/2020 |
Dental/ ENT |
4-263 |
Complete |
ISO |
9693 Third edition 2019-10 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
ANSI ADA |
Standard No. 38-2020 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
08/21/2017 |
Dental/ ENT |
4-239 |
Complete |
ANSI AAMI |
CI86:2017 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
12/23/2024 |
Dental/ ENT |
4-331 |
Complete |
ISO |
28399 Third edition 2021-03 |
Dentistry - External tooth bleaching products |
ANSI ADA |
Standard No. 136-2022 |
Dentistry - External Tooth Bleaching Products |
12/20/2021 |
Dental/ ENT |
4-291 |
Complete |
ISO |
28399 First edition 2011-01 |
Dentistry - Products for external tooth bleaching |
ANSI ADA |
Standard No. 136-2015 (R2020) |
Products for External Tooth Bleaching |
12/23/2024 |
Dental/ ENT |
4-332 |
Complete |
ADA ANSI |
Standard No. 206-2024 |
Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File |
12/23/2024 |
Dental/ ENT |
4-333 |
Complete |
ISO |
3630-4 Second edition 2023-08 |
Dentistry - Endodontic instruments - Part 4: Auxiliary instruments |
05/30/2022 |
Dental/ ENT |
4-293 |
Complete |
ANSI ADA |
Standard No. 119-2021 |
Manual Toothbrushes |
01/14/2019 |
Dental/ ENT |
4-248 |
Complete |
ISO |
10477 Third edition 2018-06 |
Dentistry - Polymer-based crown and veneering materials |
12/21/2020 |
Dental/ ENT |
4-271 |
Complete |
ANSI ADA |
Standard No. 34-2013 |
Dental Cartridge Syringes |
12/23/2024 |
Dental/ ENT |
4-329 |
Complete |
ISO |
6872 Fifth edition 2024-08 |
Dentistry - Ceramic materials |
05/29/2024 |
Dental/ ENT |
4-326 |
Complete |
ISO |
9687 Second edition 2015-02 |
Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] |
05/29/2024 |
Dental/ ENT |
4-327 |
Complete |
ISO |
21531 First edition 2009-02 |
Dentistry - Graphical symbols for dental instruments |
09/09/2008 |
Dental/ ENT |
4-145 |
Complete |
ISO |
22803 First edition 2004-09-01 |
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
05/29/2023 |
Dental/ ENT |
4-307 |
Complete |
ISO |
13504 First edition 2012-07 |
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment |
05/29/2023 |
Dental/ ENT |
4-308 |
Complete |
ISO |
14708-7 Second edition 2019-12 |
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems |
12/21/2020 |
Dental/ ENT |
4-272 |
Complete |
ANSI ADA |
Standard No. 63-2013 |
Root Canal Barbed Broaches and Rasps |
01/14/2019 |
Dental/ ENT |
4-256 |
Complete |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
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 |
12/21/2020 |
Dental/ ENT |
4-265 |
Complete |
ISO |
10271 Third edition 2020-08 |
Dentistry - Corrosion test methods for metallic materials |
ANSI ADA |
Standard No. 97-2020 |
Corrosion Test Methods for Metallic Materials |
12/21/2020 |
Dental/ ENT |
4-270 |
Complete |
ANSI ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
06/07/2021 |
Dental/ ENT |
4-274 |
Complete |
ANSI ASA |
S3.2-2020 |
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
07/09/2014 |
Dental/ ENT |
4-97 |
Complete |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
07/06/2020 |
General I (QS/ RM) |
5-129 |
Complete |
IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
04/04/2016 |
General I (QS/ RM) |
5-98 |
Complete |
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) |
07/06/2020 |
General I (QS/ RM) |
5-128 |
Complete |
ISTA |
3E 2017 |
Similar Packaged-Products in Unitized Loads of Truckload Shipment |
07/06/2020 |
General I (QS/ RM) |
5-127 |
Complete |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
06/15/2016 |
General I (QS/ RM) |
5-102 |
Complete |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
01/14/2019 |
General I (QS/ RM) |
5-122 |
Complete |
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) |
5-57 |
Partial |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
12/23/2016 |
General I (QS/ RM) |
5-113 |
Complete |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
12/23/2019 |
General I (QS/ RM) |
5-125 |
Complete |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
12/21/2020 |
General I (QS/ RM) |
5-133 |
Complete |
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 |
12/23/2024 |
General I (QS/ RM) |
5-143 |
Complete |
ISO |
14630 Fffth edition 2024-09 |
Non-active surgical implants -- General requirements |
01/14/2019 |
General I (QS/ RM) |
5-120 |
Complete |
IEC |
60812 Edition 3.0 2018-08 |
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
09/17/2018 |
General I (QS/ RM) |
5-42 |
Complete |
ASTM |
D903-98 (Reapproved 2017) |
Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds |
01/30/2014 |
General I (QS/ RM) |
5-84 |
Complete |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
12/21/2020 |
General I (QS/ RM) |
5-131 |
Complete |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
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 |
ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
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 [Including Amendment 2 (2021)] |
08/21/2017 |
General I (QS/ RM) |
5-107 |
Complete |
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)] |
ANSI AAMI ISO |
80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
01/30/2014 |
General I (QS/ RM) |
5-47 |
Complete |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
01/14/2019 |
General I (QS/ RM) |
5-121 |
Complete |
ISO |
80369-1 Second edition 2018-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
06/27/2016 |
General I (QS/ RM) |
5-108 |
Complete |
ISO |
80369-6 First Edition 2016-03-15 |
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. |
12/23/2019 |
General I (QS/ RM) |
5-124 |
Complete |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
01/27/2015 |
General I (QS/ RM) |
5-48 |
Complete |
ANSI |
Z1.9-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming |
07/09/2014 |
General I (QS/ RM) |
5-88 |
Complete |
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)] |
05/29/2024 |
General I (QS/ RM) |
5-142 |
Complete |
ISO |
780 Fifth edition 2015-12-01 |
Packaging - Distribution packaging - Graphical symbols for handling and storage of packages |
12/19/2022 |
General I (QS/ RM) |
5-137 |
Complete |
IEC |
TR 60878 Ed. 4.0 2022-11 |
Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)] |
12/19/2022 |
General I (QS/ RM) |
5-136 |
Complete |
ASTM |
D4332-22 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
12/19/2022 |
General I (QS/ RM) |
5-141 |
Complete |
ASME |
V&V 20-2009 (R2021) |
Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer |
12/20/2021 |
General I (QS/ RM) |
5-134 |
Complete |
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 |
08/14/2015 |
General I (QS/ RM) |
5-97 |
Complete |
ISO |
80369-20 First edition 2015-05-15 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
ANSI AAMI ISO |
80369-20:2015 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
01/27/2015 |
General I (QS/ RM) |
5-62 |
Complete |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
12/19/2022 |
General I (QS/ RM) |
5-135 |
Complete |
ISO |
20417 First edition 2021-04 Corrected version 2021-12 |
Medical devices - Information to be supplied by the manufacturer |
12/19/2022 |
General I (QS/ RM) |
5-138 |
Complete |
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 |
12/19/2022 |
General I (QS/ RM) |
5-140 |
Complete |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
07/15/2019 |
General I (QS/ RM) |
5-123 |
Complete |
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)]. |
07/06/2020 |
General I (QS/ RM) |
5-130 |
Complete |
ISO |
7010 Third edition 2019-07 |
Graphical symbols - Safety colours and safety signs - Registered safety signs |
12/19/2022 |
General I (QS/ RM) |
5-139 |
Complete |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
12/21/2020 |
General I (QS/ RM) |
5-132 |
Complete |
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 |
07/06/2020 |
General I (QS/ RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
12/21/2020 |
General II (ES/ EMC) |
19-38 |
Partial |
IEC |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
12/20/2021 |
General II (ES/ EMC) |
19-42 |
Partial |
IEC |
61326-1 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
12/20/2021 |
General II (ES/ EMC) |
19-43 |
Partial |
IEC |
61326-2-6 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
05/29/2024 |
General II (ES/ EMC) |
19-50 |
Partial |
IEC |
TS 60601-4-2 Edition 1.0 2024-03 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
09/17/2018 |
General II (ES/ EMC) |
19-19 |
Partial |
IEC |
TR 60601-4-2 Edition 1.0 2016-05 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
07/15/2019 |
General II (ES/ EMC) |
19-35 |
Complete |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
12/23/2024 |
General II (ES/ EMC) |
19-51 |
Complete |
UL |
1642 Sixth Edition September 29, 2020 |
Standard For Safety Lithium Batteries |
12/21/2020 |
General II (ES/ EMC) |
19-36 |
Partial |
IEC |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
ANSI AAMI IEC |
60601-1-2:2014 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] |
04/03/2023 |
General II (ES/ EMC) |
19-34 |
Complete |
IEC |
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
- Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section |
12/21/2020 |
General II (ES/ EMC) |
19-39 |
Complete |
IEC |
60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
ANSI AAMI IEC |
60601-1-12:2016 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)] |
12/20/2021 |
General II (ES/ EMC) |
19-44 |
Complete |
IEEE ANSI |
C63.24-2021 |
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems |
08/21/2017 |
General II (ES/ EMC) |
19-27 |
Complete |
IEC |
62485-3 Edition 2.0 2014-07 |
Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries |
12/21/2020 |
General II (ES/ EMC) |
19-37 |
Complete |
IEC |
60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers |