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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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
06/15/2016 Cardiovascular 3-132 Complete ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
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
01/14/2019 Cardiovascular 3-52 Partial ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
06/07/2021 Cardiovascular 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
12/18/2023 Cardiovascular 3-105 Partial IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
ANSI AAMI IEC 60601-2-25:2011/(R)2016 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
05/25/2026 Cardiovascular 3-205 Partial ISO 5840-1 Second edition 2021-01 01 [Including AMD1:2025] Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements [Including: AMENDMENT 1 (2025)]
12/18/2023 Cardiovascular 3-126 Partial IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
12/22/2025 Cardiovascular 3-203 Partial IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
01/14/2019 Cardiovascular 3-86 Partial ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
12/23/2024 Cardiovascular 3-195 Partial ISO 5910 Second edition 2024-07 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
12/23/2024 Cardiovascular 3-196 Partial ISO 81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024] Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)]
06/07/2021 Cardiovascular 3-168 Partial IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
06/07/2021 Cardiovascular 3-166 Partial ISO 81060-2 Third edition 2018-11 [Including AMD1:2020] Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
01/14/2019 Cardiovascular 3-159 Partial ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
07/06/2020 Cardiovascular 3-123 Partial IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
ANSI AAMI IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
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)]
12/22/2025 Cardiovascular 3-201 Complete IEC 60601-2-31 Edition 3.0 2020-01 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
08/06/2013 Cardiovascular 3-115 Complete IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
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
12/20/2021 Cardiovascular 3-174 Partial ISO 5840-1 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
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
12/22/2025 Dental/
ENT
4-354 Partial ISO 17730 Third edition 2025-09 Dentistry - Fluoride varnishes
12/18/2023 Dental/
ENT
4-319 Partial ISO 17730 Second edition 2020-09 Dentistry - Fluoride varnishes
ANSI ADA Standard No. 117-2022 Dentistry - Fluoride Varnishes
05/29/2023 Dental/
ENT
4-306 Partial ISO 22052 First edition 2020-06 Dentistry - Compressed air source equipment
ANSI ADA Standard No. 94-2021 Central Compressed Air Source Equipment
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
12/18/2023 Dental/
ENT
4-310 Complete ISO 22112 Second edition 2017-08 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2021 Artificial Teeth for Dental Prostheses
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. 97-2022 Corrosion Test Methods for Metallic Materials
12/23/2024 Dental/
ENT
4-335 Complete ISO 11499 Third edition 2014-06 Dentistry - Single-use cartridges for local anaesthetics
ANSI ADA Standard No. 190-2020 Single-Use Dental Cartridges for Local Anesthetics
12/18/2023 Dental/
ENT
4-311 Complete ISO 9917-2 Third edition 2017-09 Dentistry - Water-based cements - Part 2: Resin-modified cements
07/15/2019 Dental/
ENT
4-259 Partial ISO 14801 Third edition 2016-11-01 Dentistry - Implants - Dynamic loading test for endosseous dental implants
ANSI ADA Standard No. 127-2018 Dynamic Loading Test for Endosseous Dental Implants
06/07/2021 Dental/
ENT
4-276 Partial ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
ANSI ADA Standard No. 35-2019 Dental Handpieces and Motors
05/29/2023 Dental/
ENT
4-305 Partial ISO 10637 Second edition 2018-05 Dentistry - Central suction source equipment
ANSI ADA Standard No. 177-2020 Central Suction Source Equipment
12/18/2023 Dental/
ENT
4-321 Complete ISO 23450 First edition 2021-03 Dentistry - Intraoral camera
ANSI ADA Standard No. 213-2024 Dentistry - Intra Oral Camera
05/25/2026 Dental/
ENT
4-380 Complete ISO 13017 Second edition 2020-07 Dentistry - Magnetic attachments
ANSI ADA Standard No. 201-2022 Dentistry - Magnetic Attachments
05/25/2026 Dental/
ENT
4-381 Complete ISO 13078 First edition 2013-02 Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple
ANSI ADA Standard No.163-2018 Dental Furnance, Part 1: Test Method for Temperature Measurement with Separate Thermocouple
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
05/29/2023 Dental/
ENT
4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
05/25/2026 Dental/
ENT
4-391 Complete ISO 16498 First edition 2013-07 Dentistry - Minimal dental implant data set for clinical use
ANSI ADA Standard No. 172-2019 Minimal Dental Implant Data Set for Clinical Use
08/06/2013 Dental/
ENT
4-204 Complete ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2025) 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 Complete ANSI ASA S3.45-2009 (Reaffirmed 2024) American National Standard Procedures for Testing Basic Vestibular Function
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
05/25/2026 Dental/
ENT
4-374 Complete ANSI ADA Standard No. 195-2021 Dental Tweezers
09/17/2018 Dental/
ENT
4-247 Complete ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
ANSI ADA Standard No. 184-2020 Laser Welding and Filler Materials in Dentistry
05/25/2026 Dental/
ENT
4-386 Complete ISO 13397-3 First edition 1996-09 Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-type
05/25/2026 Dental/
ENT
4-378 Complete ISO 9173-2 First edition 2010-05 Dentistry - Extraction forceps - Part 2: Designation
05/25/2026 Dental/
ENT
4-379 Complete ISO 9173-3 First edition 2014-05 Dentistry - Extraction forceps - Part 3: Design
08/21/2017 Dental/
ENT
4-233 Complete ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
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
08/06/2013 Dental/
ENT
4-90 Complete ANSI ASA S3.39:1987 (Reaffirmed 2025) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
01/14/2019 Dental/
ENT
4-171 Complete ANSI ASA S3.37-1987 (Reaffirmed 2025) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
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
05/25/2026 Dental/
ENT
4-393 Complete ISO 21533 Second edition 2018-01 Dentistry - Reprocessable cartridge syringes for intraligamentary injections
ANSI ADA Standard No. 183-2020 Reprocessable Cartridge Syringes for Intraligamentary Injections
12/23/2024 Dental/
ENT
4-336 Complete ISO 18397 First edition 2016-01 Dentistry - Powered scaler
ANSI ADA Standard No. 157-2020 Powered Dental Scaler Handpieces and Tips
05/29/2023 Dental/
ENT
4-303 Complete ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
ANSI ADA Standard No. 88-2024 Dentistry - Dental Brazing Materials
05/29/2023 Dental/
ENT
4-304 Complete ISO 21606 Second edition 2022-08 Dentistry - Elastomeric auxiliaries for use in orthodontics
06/07/2021 Dental/
ENT
4-279 Complete ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT
4-283 Complete ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
ANSI ADA Standard No. 125-2018 (R2022) Manual Interdental Brushes
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
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
12/23/2024 Dental/
ENT
4-332 Complete ANSI ADA 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
ANSI ADA Standard No. 101-4-2025 Dentistry - Endodontic Instruments - Part 4: Auxiliary Instruments
12/18/2023 Dental/
ENT
4-315 Complete ISO 24234 Third edition 2021-08 Dentistry - Dental Amalgam
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
4-163 Complete ANSI ASA S3.5-1997 (Reaffirmed 2024) American National Standard Methods for Calculation of the Speech Intelligibility Index
12/20/2021 Dental/
ENT
4-288 Complete ISO 7488 Second edition 2018-04 Dentistry - Mixing machines for dental amalgam
ANSI ADA Standard No. 43-2020 (R2025) Electrically Powered Dental Amalgamators
05/29/2023 Dental/
ENT
4-299 Complete ISO 3107 Fifth edition 2022-09 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
ANSI ADA Standard No. 30-2023 Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements
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
4-180 Complete ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
12/23/2019 Dental/
ENT
4-260 Complete ANSI ASA S12.2-2019 (Reaffirmed 2023) American National Standard for Criteria for Evaluating Room Noise
12/23/2024 Dental/
ENT
4-330 Complete ANSI ADA Standard No. 63-2020 Endodontic Instruments - Auxillary
12/21/2020 Dental/
ENT
4-266 Complete ISO 19023 First edition 2018-02 Dentistry - Orthodontic anchor screws
ANSI ADA Standard No. 178-2019 Orthodontic Anchor Screws
12/21/2020 Dental/
ENT
4-268 Complete ISO 15841 Second edition 2014-08 Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
ANSI ADA Standard No. 32-2017 Orthodontic Wires
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
12/21/2020 Dental/
ENT
4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
12/20/2021 Dental/
ENT
4-285 Complete ANSI ADA Standard No. 37-1986 (R2025) Dental Abrasive Powders
05/25/2026 Dental/
ENT
4-387 Complete ISO 13397-5 First edition 2015-09 Dentistry - Periodontal curettes, dental scalers and excavators - Part 5: Jacquette scalers
05/25/2026 Dental/
ENT
4-388 Complete ISO 14356 Second edition 2024-10 Dentistry - Duplicating material
05/25/2026 Dental/
ENT
4-389 Complete ISO 15098 Second edition 2024-07 Dentistry - Dental tweezers
12/21/2020 Dental/
ENT
4-271 Complete ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
12/22/2025 Dental/
ENT
4-350 Complete ANSI ASA S3.6-2025 American National Standard Specification for Audiometers
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
12/21/2020 Dental/
ENT
4-272 Complete ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
12/23/2019 Dental/
ENT
4-261 Complete 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 Complete 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
05/25/2026 Dental/
ENT
4-397 Complete ISO 23298 First edition 2023-05 Dentistry - Test methods for machining accuracy of computer-aided milling machines
05/25/2026 Dental/
ENT
4-398 Complete ISO 23940 First edition 2021-04 Dentistry - Excavators
05/25/2026 Dental/
ENT
4-399 Complete ANSI ADA Standard No. 182-2021 Test Method for the Bonding Test Between Polymer Teeth and Denture Base Polymer
ISO TS 19736 First edition 2017-09 Dentistry - Bonding test between polymer teeth and denture base materials
12/22/2025 Dental/
ENT
4-364 Complete ISO 3990 First edition 2023-07 Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials
01/14/2019 Dental/
ENT
4-162 Complete ANSI ASA S3.4-2007 (Reaffirmed 2025) American National Standard Procedure for the Computation of Loudness of Steady Sounds
05/25/2026 Dental/
ENT
4-375 Complete ANSI ADA Standard No. 197-2021 Spoons and Bone Curettes in Dentistry
05/25/2026 Dental/
ENT
4-376 Complete ISO 7492 Fourth edition 2019-03 Dentistry - Dental explorer
05/25/2026 Dental/
ENT
4-377 Complete ISO 9173-1 Third edition 2016-10 Dentistry - Extraction forceps - Part 1: General requirements
05/25/2026 Dental/
ENT
4-373 Complete ANSI ADA Standard No. 170-2019 Periodontal Probes - Dental Excavators - Discoid Type: General Requirements
07/15/2019 Dental/
ENT
4-258 Complete ISO 10139-2 Third edition 2016-06-15 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
ANSI ADA Standard No. 160-2020 (R2025) Dentistry - Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
06/07/2021 Dental/
ENT
4-277 Complete ANSI IEEE C63.19-2019 American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
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
4-165 Complete ANSI ASA S3.13-1987 (Reaffirmed 2024) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
01/30/2014 Dental/
ENT
4-199 Complete ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
12/19/2022 Dental/
ENT
4-294 Complete ANSI ADA Standard No. 139-2020 (R2025) Dental Base Polymers
 
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