• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
-
301 to 400 of 1619 Results
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
Results per Page
New Search export reports to excelExport to Excel HelpStandards Search Assistance
Date of
Entry
Sort by Date [Old to new]
Sort by Date [New to old]
Specialty Task
Group Area
Sort by Specialty Task Group Area [A-Z]
Sort by Specialty Task Group Area [Z-A]
Recognition
Number
Sort by Recognition Number [0-9]
Sort by Recognition Number [9-0]
Extent of
Recognition
Sort by Extent of Recognition [A-Z]
Sort by Extent of Recognition [Z-A]
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
 
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
 
-
-