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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
06/07/2021 General II (ES/
EMC)
19-40 IEC 60086-4 Edition 5.0 2019-04 Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
12/21/2020 General II (ES/
EMC)
19-39 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
12/21/2020 General II (ES/
EMC)
19-38 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
12/21/2020 General II (ES/
EMC)
19-37 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
12/21/2020 General II (ES/
EMC)
19-36 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
07/15/2019 General II (ES/
EMC)
19-35 UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
01/14/2019 General II (ES/
EMC)
19-34 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)]
12/23/2019 General II (ES/
EMC)
19-33 IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/23/2019 General II (ES/
EMC)
19-32 IEC 62133-1 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
09/17/2018 General II (ES/
EMC)
19-31 ANSI IEEE C63.15-2017 (Revision of ANSI C63.15-2010) American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
09/17/2018 General II (ES/
EMC)
19-30 AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
08/21/2017 General II (ES/
EMC)
19-29 ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
08/21/2017 General II (ES/
EMC)
19-28 IEC 62485-4 Edition 1.0 2015-01 Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
08/21/2017 General II (ES/
EMC)
19-27 IEC 62485-3 Edition 2.0 2014-07 Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
08/21/2017 General II (ES/
EMC)
19-26 IEC 62485-2 Edition 1.0 2010-06 Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
08/21/2017 General II (ES/
EMC)
19-25 IEC 62485-1 Edition 1.0 2015-04 Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
08/21/2017 General II (ES/
EMC)
19-24 IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
08/21/2017 General II (ES/
EMC)
19-23 IEC 60086-4 Edition 4.0 2014-09 Primary batteries - Part 4: Safety of lithium batteries
08/21/2017 General II (ES/
EMC)
19-22 AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
12/23/2016 General II (ES/
EMC)
19-20 ANSI IEEE C63.16-2016 (Revision of ANSI C63.16-1993) American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
09/17/2018 General II (ES/
EMC)
19-19 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
04/04/2016 General II (ES/
EMC)
19-17 ANSI IEEE C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
04/04/2016 General II (ES/
EMC)
19-16 ANSI AAMI HA60601-1-11:2015 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD)
06/27/2016 General II (ES/
EMC)
19-15 IEC 60601-1-12 Edition 1.0 2014-06 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
06/27/2016 General II (ES/
EMC)
19-14 IEC 60601-1-11 Edition 2.0 2015-01 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
12/23/2019 General II (ES/
EMC)
19-13 IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
07/09/2014 General II (ES/
EMC)
19-11 UL 2054 2nd Edition Household and Commercial Batteries
07/09/2014 General II (ES/
EMC)
19-10 UL 1642 5th Edition Lithium Batteries
07/09/2014 General II (ES/
EMC)
19-9 IEC 60601-1-10 Edition 1.1 2013-11 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
09/17/2018 General II (ES/
EMC)
19-8 ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
07/09/2014 General II (ES/
EMC)
19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
12/21/2020 Nanotechnology 18-18 ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
12/21/2020 Nanotechnology 18-17 ISO 21363 First edition 2020-06 Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
07/06/2020 Nanotechnology 18-16 ISO /TS 21362 First edition 2018-06 Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation
07/06/2020 Nanotechnology 18-15 ASTM E3025-16 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
07/15/2019 Nanotechnology 18-14 ISO /TR 11360 First edition 2010-07-15 Nanotechnologies - Methodology for the classification and categorization of nanomaterials
07/15/2019 Nanotechnology 18-13 ISO /TS 18827 First edition 2017-06 Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials
01/14/2019 Nanotechnology 18-12 ISO /TS 17200 First edition 2013-06-01 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
01/14/2019 Nanotechnology 18-11 ISO /TR 13121 First edition 2011-05-15 Nanotechnologies - Nanomaterial risk evaluation
06/07/2018 Nanotechnology 18-10 ISO 29701 First edition 2010-09-15 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test.
06/07/2018 Nanotechnology 18-9 ISO /TR 13014 First edition 2012-05-15 Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
01/14/2019 Nanotechnology 18-8 ASTM E2578-07 (Reapproved 2018) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions
01/14/2019 Nanotechnology 18-7 ASTM E2834-12 (Reapproved 2018) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)
01/14/2019 Nanotechnology 18-6 ASTM E2865-12 (Reapproved 2018) Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
01/14/2019 Nanotechnology 18-5 ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
08/14/2015 Nanotechnology 18-4 ISO TS 80004-6 First edition 2013-11-01 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
01/27/2015 Nanotechnology 18-3 ISO TS 14101 First edition 2012-11-01 Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
01/14/2019 Nanotechnology 18-2 ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
04/04/2016 Nanotechnology 18-1 ASTM E2490-09 (Reapproved 2015) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
12/21/2020 Neurology 17-17 ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
06/07/2018 Neurology 17-16 IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
06/07/2018 Neurology 17-15 ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
01/14/2019 Neurology 17-14 ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators
01/27/2015 Neurology 17-13 IEEE Std 2010-2012 Recommended Practice for Neurofeedback Systems
01/30/2014 Neurology 17-12 ISO 7197 Third edition 2006-06-01 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
08/14/2015 Neurology 17-4 ASTM F647-94 (Reapproved 2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
06/07/2018 Neurology 17-1 AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
06/07/2021 Physical Medicine 16-231 ISO 10328 Second edition 2016-06-01 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
12/21/2020 Physical Medicine 16-230 ANSI RESNA WC-2:2019 Section 25 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs
12/23/2019 Physical Medicine 16-229 ANSI RESNA WC-4:2017 Section 20 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles
12/23/2019 Physical Medicine 16-228 ANSI RESNA WC-4:2017 Section 19 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles.
12/23/2019 Physical Medicine 16-227 RESNA WC-4:2017 Section 18 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles.
12/23/2019 Physical Medicine 16-226 ANSI RESNA WC-4:2017 Section 10 American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers.
12/23/2019 Physical Medicine 16-225 ANSI RESNA WC-1:2019 Section 26 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
12/23/2019 Physical Medicine 16-224 ANSI RESNA WC-2:2019 Section 21 American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
12/23/2019 Physical Medicine 16-223 ANSI RESNA WC-1:2019 Section 22 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures
12/23/2019 Physical Medicine 16-222 ANSI RESNA WC-1:2019 Section 20 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs
12/23/2019 Physical Medicine 16-221 ANSI RESNA WC-1:2019 Section 16 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods
12/23/2019 Physical Medicine 16-220 ANSI RESNA WC-1:2019 Section 15 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling
12/23/2019 Physical Medicine 16-219 ANSI RESNA WC-2:2019 Section 14 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods
12/23/2019 Physical Medicine 16-218 ANSI RESNA WC-1:2019 Section 13 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces
12/23/2019 Physical Medicine 16-217 ANSI RESNA WC-1:2019 Section 11 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins
12/23/2019 Physical Medicine 16-216 ANSI RESNA WC-2:2019 Section 10 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
12/23/2019 Physical Medicine 16-215 ANSI RESNA WC-2:2019 Section 9 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs
12/23/2019 Physical Medicine 16-214 ANSI RESNA WC-1:2019 Section 8 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths
12/23/2019 Physical Medicine 16-213 ANSI RESNA WC-1:2019 Section 7 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions
12/23/2019 Physical Medicine 16-212 ANSI RESNA WC-2:2019 Section 6 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs.
12/23/2019 Physical Medicine 16-211 ANSI RESNA WC-1:2019 Section 5 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space
12/23/2019 Physical Medicine 16-210 ANSI RESNA WC-2:2019 Section 4 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range
12/23/2019 Physical Medicine 16-209 ANSI RESNA WC-1:2019 Section 3 American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes
12/23/2019 Physical Medicine 16-208 ANSI RESNA WC-2:2019 Section 2 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs
12/23/2019 Physical Medicine 16-207 ANSI RESNA WC-1:2019 Section 1 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability
07/15/2019 Physical Medicine 16-206 ISO 7176 - 30 First edition 2018-12 Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
01/14/2019 Physical Medicine 16-204 ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
09/17/2018 Physical Medicine 16-203 ASME A18.1-2017 Safety Standard for Platform Lifts and Stairway Chairlifts
09/17/2018 Physical Medicine 16-202 ISO 7176-2 Third edition 2017-10 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
06/07/2018 Physical Medicine 16-201 ISO 7176-19 Second Edition 2008-07-15 Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]
12/23/2016 Physical Medicine 16-199 ISO 7176-28 First edition 2012-10-1 Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
04/04/2016 Physical Medicine 16-198 ISO 7176-22 Second edition 2014-09-01 Wheelchairs - Part 22: Set-up procedures
04/04/2016 Physical Medicine 16-197 ISO 7176-8 Second editon 2014-12-15 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
04/04/2016 Physical Medicine 16-196 ISO 7176-7 First Edition 1998-05-15 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
04/04/2016 Physical Medicine 16-195 ISO 7176-1 Third edition 2014-10-01 Wheelchairs - Part 1: Determination of static stability
08/14/2015 Physical Medicine 16-194 ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
08/06/2013 Physical Medicine 16-192 ISO 7176-3 Third edition 2012-12-15 Wheelchairs - Part 3: Determination of effectiveness of brakes
08/06/2013 Physical Medicine 16-191 ISO 7176-16 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices
08/06/2013 Physical Medicine 16-190 ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies
01/30/2014 Physical Medicine 16-167 ISO 7176-9 Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
01/30/2014 Physical Medicine 16-166 ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
01/30/2014 Physical Medicine 16-165 ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
01/30/2014 Physical Medicine 16-164 ISO 7176-10 Second edition 2008-11-01 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
 
 
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