|
|
|
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)
|
| 01/14/2019 |
Dental/
ENT |
4-257 |
Partial |
ISO |
17730 First edition 2014-11-01 |
Dentistry - Fluoride varnishes |
| 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 |
4-255 |
Complete |
ANSI ADA |
Standard No. 131-2015 (R2020) |
Dental CAD/CAM Machinable Zirconia Blanks |
| 01/14/2019 |
Dental/
ENT |
4-254 |
Complete |
ANSI ADA |
Standard No. 99-2001 (R2013) |
Athletic Mouth Protectors and Materials |
| 01/14/2019 |
Dental/
ENT |
4-252 |
Complete |
ISO |
10650 Second edition 2018-08 |
Dentistry - Powered polymerization activators |
| ANSI ADA |
Standard No. 48-2020 |
Curing Lights (Powered Polymerization Activators) |
| 01/14/2019 |
Dental/
ENT |
4-251 |
Complete |
ISO |
6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] |
Dentistry - Ceramic materials |
| ANSI ADA |
Standard No. 69-2020 |
Dental Ceramic |
| 01/14/2019 |
Dental/
ENT |
4-250 |
Complete |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 01/14/2019 |
Dental/
ENT |
4-248 |
Complete |
ISO |
10477 Third edition 2018-06 |
Dentistry - Polymer-based crown and veneering materials |
| 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 |
| 09/17/2018 |
Dental/
ENT |
4-246 |
Complete |
ISO |
20749 First edition 2017-03 |
Dentistry - Pre-capsulated dental amalgam |
| ANSI ADA |
Standard No. 144-2018 |
Alloy for Dental Amalgam |
| 09/17/2018 |
Dental/
ENT |
4-244 |
Complete |
ISO |
8325 Second edition 2004-09-15 |
Dentistry - Test methods for rotary instruments |
| 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 |
| 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 |
| 06/07/2018 |
Dental/
ENT |
4-240 |
Complete |
ISO |
21563 First edition 2013-08-15 |
Dentistry - Hydrocolloid impression materials |
| ANSI ADA |
Standard No. 128-2015 |
Hydrocolloid Impression Materials |
| 08/21/2017 |
Dental/
ENT |
4-239 |
Complete |
ANSI AAMI |
CI86:2017 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 08/21/2017 |
Dental/
ENT |
4-238 |
Complete |
ISO |
20127 First edition 2005-03-15 |
Dentistry - Powered toothbrushes - General requirements and test methods |
| ANSI ADA |
Standard No.120-2009 (R2014) |
Powered Toothbrushes |
| 08/21/2017 |
Dental/
ENT |
4-233 |
Complete |
ISO |
20795-2 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 08/21/2017 |
Dental/
ENT |
4-232 |
Complete |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
| 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 |
4-227 |
Complete |
ISO |
22674 Second edition 2016-01-15 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
| ANSI ADA |
Standard No. 134-2018 |
Metallic Materials for Fixed and Removable Restorations and Appliances |
| 04/04/2016 |
Dental/
ENT |
4-224 |
Complete |
ISO |
24234 Second edition 2015-05-01 |
Dentistry - Dental Amalgam |
| 04/04/2016 |
Dental/
ENT |
4-222 |
Complete |
ISO |
6874 Third edition 2015-09-01 |
Dentistry - Polymer-based pit and fissure sealants |
| 04/04/2016 |
Dental/
ENT |
4-221 |
Complete |
ISO |
7494-2 Second edition 2015-04-01 |
Dentistry - Dental units - Part 2: Air, water, suction and waste water systems |
| 08/14/2015 |
Dental/
ENT |
4-220 |
Complete |
ANSI ASA |
S3.22-2014 (Reaffirmed 2020) |
American National Standard Specification of Hearing Aid Characteristics |
| 01/27/2015 |
Dental/
ENT |
4-219 |
Complete |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-217 |
Complete |
ANSI ASA |
S3.36-2012 (Reaffirmed 2022) |
American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements |
| 08/21/2017 |
Dental/
ENT |
4-215 |
Complete |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
| 07/09/2014 |
Dental/
ENT |
4-211 |
Complete |
ANSI ASA |
S3.46-2013 (Reaffirmed 2023) |
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
| 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) |
| 06/27/2016 |
Dental/
ENT |
4-202 |
Complete |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
| 01/30/2014 |
Dental/
ENT |
4-199 |
Complete |
ISO |
6876 Third edition 2012-06-01 |
Dentistry -- Root canal sealing materials |
| 01/30/2014 |
Dental/
ENT |
4-198 |
Complete |
ISO |
3107 Fourth edition 2011-03-01 |
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements |
| ANSI ADA |
Standard No. 30-2013 (R2018) |
Dental Zinc Oxide-Eugenol and Zinc Oxide |
| 04/04/2016 |
Dental/
ENT |
4-190 |
Complete |
ANSI ASA |
S3.35-2010 (Reaffirmed 2020) |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions |
| 01/30/2014 |
Dental/
ENT |
4-188 |
Complete |
ISO |
9917-2 Second edition 2010-04-15 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 01/27/2015 |
Dental/
ENT |
4-185 |
Complete |
ANSI ASA |
S3.45-2009 (Reaffirmed 2019) |
American National Standard Procedures for Testing Basic Vestibular Function |
| 08/14/2015 |
Dental/
ENT |
4-184 |
Complete |
ANSI ASA |
S3.25-2009 (Reaffirmed 2019) |
American National Standard For an Occluded Ear Simulator |
| 01/30/2014 |
Dental/
ENT |
4-181 |
Complete |
ISO |
4049 Fourth edition 2009-10-01 |
Dentistry - Polymer-based restorative materials |
| 01/30/2014 |
Dental/
ENT |
4-180 |
Complete |
ISO |
9168 Third edition 2009-07-15 |
Dentistry - Hose connectors for air driven dental handpieces |
| 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 |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-171 |
Complete |
ANSI ASA |
S3.37-1987 (Reaffirmed 2020) |
American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 01/30/2014 |
Dental/
ENT |
4-153 |
Complete |
ISO |
9917-1 Second edition 2007-10-01 |
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| 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 |
| 07/09/2014 |
Dental/
ENT |
4-149 |
Complete |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
| 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 |
| 01/30/2014 |
Dental/
ENT |
4-137 |
Complete |
ISO |
6877 Second edition 2006-04-01 |
Dentistry - Root-canal obturating points |
| ANSI ADA |
Standard No. 78-2013 |
Dental obturating cones |
| 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 |
| 08/14/2015 |
Dental/
ENT |
4-130 |
Complete |
ANSI ADA |
Standard No. 17-1983 (R2014) |
Denture Base Temporary Relining Resins |
| 07/09/2014 |
Dental/
ENT |
4-97 |
Complete |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
| 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) |
| 05/29/2024 |
Cardiovascular |
3-192 |
Complete |
ISO |
22679 First edition 2021-11 |
Cardiovascular implants - Transcatheter cardiac occluders
|
| 05/29/2024 |
Cardiovascular |
3-191 |
Complete |
ISO |
18242 First edition 2016-09-01 [Including AMD1:2023] |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)] |
| 12/18/2023 |
Cardiovascular |
3-190 |
Complete |
ISO |
PAS 7020 First edition 2023-05 |
Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 |
| 12/18/2023 |
Cardiovascular |
3-189 |
Complete |
ASTM |
F2942-19 |
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents |
| 05/29/2023 |
Cardiovascular |
3-188 |
Partial |
ISO |
81060-3 First edition 2022-12 |
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
| 05/29/2023 |
Cardiovascular |
3-187 |
Complete |
ISO |
14708-6 Second edition 2019-09 |
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
| 05/29/2023 |
Cardiovascular |
3-186 |
Complete |
ISO |
14708-2 Third edition 2019-09 |
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers |
| 05/29/2023 |
Cardiovascular |
3-185 |
Partial |
ANSI AAMI |
PC76:2021 |
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |
| 05/29/2023 |
Cardiovascular |
3-184 |
Complete |
ASTM |
F2477-23 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 12/19/2022 |
Cardiovascular |
3-183 |
Complete |
ISO |
11658 First edition 2012-05-15 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| ANSI AAMI ISO |
11658: 2012 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| 05/30/2022 |
Cardiovascular |
3-182 |
Complete |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
| 05/30/2022 |
Cardiovascular |
3-181 |
Complete |
ISO |
25539-2 Third edition 2020-09 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
| 12/20/2021 |
Cardiovascular |
3-180 |
Complete |
ASTM |
F3505-21 |
Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
| 12/20/2021 |
Cardiovascular |
3-179 |
Complete |
ASTM |
F3172-15 (Reapproved 2021) |
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
| 12/20/2021 |
Cardiovascular |
3-178 |
Complete |
ASTM |
F3067-14 (Reapproved 2021) |
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
| 12/20/2021 |
Cardiovascular |
3-177 |
Complete |
ASTM |
F2606-08 (Reapproved 2021) |
Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems |
| 12/20/2021 |
Cardiovascular |
3-176 |
Complete |
ISO |
18193 First edition 2021-08 |
Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation |
| 12/20/2021 |
Cardiovascular |
3-175 |
Complete |
ISO |
5840-2 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes |
| 12/20/2021 |
Cardiovascular |
3-174 |
Partial |
ISO |
5840-1 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements |
| 12/20/2021 |
Cardiovascular |
3-173 |
Complete |
ISO |
5840-3 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques |
| 12/20/2021 |
Cardiovascular |
3-172 |
Complete |
AAMI |
TIR42:2021 |
Evaluation of Particulates Associated with Vascular Medical Devices |
| 12/20/2021 |
Cardiovascular |
3-171 |
Complete |
ASTM |
F2514-21 |
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading |
| 06/07/2021 |
Cardiovascular |
3-170 |
Complete |
ISO |
14708-5 Second edition 2020-05 |
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| 12/21/2020 |
Cardiovascular |
3-169 |
Partial |
IEC |
60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ANSI AAMI IEC |
60601-2-4:2010/A1:2018 (Consolidated Text) |
Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 |
| 06/07/2021 |
Cardiovascular |
3-168 |
Partial |
IEEE |
Std 1708-2014 |
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
| 07/06/2020 |
Cardiovascular |
3-167 |
Complete |
ISO |
TS 81060-5 First edition 2020-02 |
Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers |
| 06/07/2021 |
Cardiovascular |
3-166 |
Partial |
ISO |
81060-2 Third edition 2018-11 |
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)] |
| 07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
| 07/06/2020 |
Cardiovascular |
3-164 |
Complete |
ASTM |
F1830-19 |
Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps |
| 12/23/2019 |
Cardiovascular |
3-163 |
Partial |
ISO |
18242 First edition 2016-09-01 |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps |
| 12/23/2019 |
Cardiovascular |
3-162 |
Complete |
ASTM |
F3374-19 |
Standard Guide for Active Fixation Durability of Endovascular Prostheses |
| 12/23/2019 |
Cardiovascular |
3-161 |
Complete |
ISO |
14117 Second edition 2019-09 |
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. |
| 01/14/2019 |
Cardiovascular |
3-159 |
Partial |
ISO |
5910 First edition 2018-06 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 01/14/2019 |
Cardiovascular |
3-158 |
Complete |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 01/14/2019 |
Cardiovascular |
3-157 |
Complete |
ANSI AAMI ISO |
25539-1: 2017 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 09/17/2018 |
Cardiovascular |
3-156 |
Complete |
ISO |
14708-1 Second edition 2014-08-15 |
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| ANSI AAMI ISO |
14708-1:2014 |
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| 07/06/2020 |
Cardiovascular |
3-155 |
Complete |
IEC |
60601-2-47 Edition 2.0 2012-02 |
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems |
| ANSI AAMI IEC |
60601-2-47:2012/(R)2016 |
Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| 09/17/2018 |
Cardiovascular |
3-154 |
Complete |
ASTM |
F3211-17 |
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
| 09/17/2018 |
Cardiovascular |
3-153 |
Complete |
ASTM |
F2743-11 |
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems |
| 06/07/2018 |
Cardiovascular |
3-150 |
Complete |
ISO |
7199 Third edition 2016-11-15 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| ANSI AAMI ISO |
7199:2016 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| 08/21/2017 |
Cardiovascular |
3-149 |
Complete |
ISO |
25539-1 Second edition 2017-02 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 12/23/2016 |
Cardiovascular |
3-144 |
Complete |
ISO |
7198 Second edition 2016-08-01 |
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
| 06/27/2016 |
Cardiovascular |
3-143 |
Partial |
ISO |
12417 First edition 2015-10-01 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products |
| 01/14/2019 |
Cardiovascular |
3-138 |
Complete |
ASTM |
F2942-13 |
Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents |
![Sort by Date [Old to new]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon}
![Sort by Date [New to old]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
