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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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05/29/2024 Cardiovascular 3-192 Complete ISO 22679 First edition 2021-11 Cardiovascular implants - Transcatheter cardiac occluders
01/14/2019 Cardiovascular 3-66 Complete ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
12/20/2021 Cardiovascular 3-172 Complete AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
09/17/2018 Cardiovascular 3-154 Complete ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
12/23/2019 Cardiovascular 3-162 Complete ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
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 3-176 Complete ISO 18193 First edition 2021-08 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
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
09/17/2018 Cardiovascular 3-110 Complete AAMI TIR41:2011/(R)2025 Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
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
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
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
ANSI AAMI ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
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
12/22/2025 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
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)]
12/23/2024 Cardiovascular 3-195 Partial ISO 5910 Second edition 2024-07 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
01/14/2019 Cardiovascular 3-159 Partial ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
06/07/2021 Cardiovascular 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
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
12/23/2024 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)]
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
01/14/2019 Cardiovascular 3-52 Partial ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
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
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
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
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
06/07/2021 Cardiovascular 3-168 Partial IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
12/23/2019 Cardiovascular 3-163 Partial ISO 18242 First edition 2016-09-01 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
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
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
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
4-305 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
4-319 Partial ISO 17730 Second edition 2020-09 Dentistry - Fluoride varnishes
ANSI ADA Standard No. 117-2022 Dentistry - Fluoride Varnishes
12/22/2025 Dental/
ENT
4-354 Partial ISO 17730 Third edition 2025-09 Dentistry - Fluoride varnishes
ANSI ADA Standard No. 117-2022 Dentistry - Fluoride Varnishes
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
4-308 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
12/23/2024 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
12/23/2024 Dental/
ENT
4-337 Complete ISO 20608 First edition 2018-04 Dentistry - Powder jet handpieces and powders
06/27/2016 Dental/
ENT
4-202 Complete ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
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
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)
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
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
12/23/2024 Dental/
ENT
4-338 Complete ISO 22683 First edition 2022-05 Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems
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
4-217 Complete ANSI ASA S3.36-2012 (Reaffirmed 2022) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
12/18/2023 Dental/
ENT
4-311 Complete ISO 9917-2 Third edition 2017-09 Dentistry - Water-based cements - Part 2: Resin-modified cements
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
08/21/2017 Dental/
ENT
4-215 Complete ANSI ADA Standard No. 96-2012 Dental Water-based Cements
12/18/2023 Dental/
ENT
4-318 Complete ISO 20749 Second edition 2023-06 Dentistry - Pre-capsulated dental amalgam
04/04/2016 Dental/
ENT
4-222 Complete ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
ANSI ADA Standard No. 39-2020 Pit and Fissure Sealants
12/23/2024 Dental/
ENT
4-328 Complete ANSI ADA Standard No. 57-2021 Endodontic Sealing Materials
05/26/2025 Dental/
ENT
4-344 Complete ANSI ADA Standard No. 186-2024 Dentistry - Polymer-based Machinable Blanks
05/26/2025 Dental/
ENT
4-345 Complete ANSI ADA Standard No. 187-2024 Dentistry - Dental CAD/CAM Machinable Ceramic Blanks
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
06/27/2016 Dental/
ENT
4-228 Complete ANSI ASA S3.20-2015 (Reaffirmed 2025) American National Standard Bioacoustical Terminology
08/21/2017 Dental/
ENT
4-232 Complete ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
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)
12/18/2023 Dental/
ENT
4-315 Complete ISO 24234 Third edition 2021-08 Dentistry - Dental Amalgam
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
4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
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
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
4-272 Complete ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
05/26/2025 Dental/
ENT
4-346 Complete ISO 9680 Fourth edition 2021-11 Dentistry - Operating lights
ANSI ADA Standard No. 89-2023 Dentistry - Dental Operating Lights
05/26/2025 Dental/
ENT
4-347 Complete ISO 22254 First edition 2005-08 Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection
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
4-331 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
4-334 Complete ISO 11143 Second edition 2008-07 Dentistry - Amalgam separators
ANSI ADA Standard No. 108-2009, Addendum (R2022) Amalgam Separators
07/09/2014 Dental/
ENT
4-97 Complete ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
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)]
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 Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
08/21/2017 Dental/
ENT
4-233 Complete ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
08/06/2013 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
05/29/2024 Dental/
ENT
4-327 Complete ISO 21531 First edition 2009-02 Dentistry - Graphical symbols for dental instruments
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
12/23/2019 Dental/
ENT
4-260 Complete ANSI ASA S12.2-2019 (Reaffirmed 2023) American National Standard for Criteria for Evaluating Room Noise
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
05/29/2023 Dental/
ENT
4-303 Complete ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
05/29/2023 Dental/
ENT
4-304 Complete ISO 21606 Second edition 2022-08 Dentistry - Elastomeric auxiliaries for use in orthodontics
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
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
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
12/23/2024 Dental/
ENT
4-330 Complete ANSI ADA Standard No. 63-2020 Endodontic Instruments - Auxillary
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
12/21/2020 Dental/
ENT
4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
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
4-256 Complete ANSI ADA Standard No. 132-2015 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
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
06/07/2021 Dental/
ENT
4-273 Complete ANSI ASA S3.7-2016 (Reaffirmed 2025) American National Standard Method for Coupler Calibration of Earphones
06/07/2021 Dental/
ENT
4-278 Complete ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
ANSI ADA Standard No. 19-2022 Elastomeric Impression and Bite Registration
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 Manual Interdental Brushes
12/20/2021 Dental/
ENT
4-284 Complete ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
 
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