Recognized Consensus Standards: Medical Devices
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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) |
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 |
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 | ||||
01/30/2014 | 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 |
4-160 | Complete | ANSI ASA | S3.1-1999 (Reaffirmed 2023) | American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
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 |
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 |
4-188 | Complete | ISO | 9917-2 Second edition 2010-04-15 | Dentistry - Water-based cements - Part 2: Resin-modified cements |
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 |
4-198 | 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 | ||||
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) |