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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2019 Physical Medicine 16-213 Complete RESNA ANSI 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 16-214 Complete RESNA ANSI 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
01/30/2014 Physical Medicine 16-27 Complete ISO 7176-15 First edition 1996-11-15 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
01/30/2014 Physical Medicine 16-163 Complete ISO 7176-5 Second edition 2008-06-01 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
12/23/2019 Physical Medicine 16-207 Complete RESNA ANSI 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
12/23/2019 Physical Medicine 16-209 Complete RESNA ANSI 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 16-210 Complete RESNA ANSI 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 16-227 Complete 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 16-229 Complete RESNA ANSI 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 16-222 Complete RESNA ANSI 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 16-218 Complete RESNA ANSI 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
12/21/2020 Physical Medicine 16-230 Complete RESNA ANSI 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
05/30/2022 Physical Medicine 16-166 Partial 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
12/20/2021 Radiology 12-341 Complete IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
03/31/2006 Radiology 12-141 Complete IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
05/30/2022 Radiology 12-345 Complete IEC 61223-3-7 Edition 1.0 2021-12 Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
03/16/2012 Radiology 12-232 Complete NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
03/16/2012 Radiology 12-242 Complete IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
07/09/2014 Radiology 12-282 Complete ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
09/09/2008 Radiology 12-165 Complete NEMA XR 22-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
07/06/2020 Radiology 12-331 Complete NEMA Standards Publication MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
08/14/2015 Radiology 12-292 Complete IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
07/09/2014 Radiology 12-272 Complete IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
01/30/2014 Radiology 12-266 Complete IEC 61689 Edition 3.0 2013-02 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
05/30/2022 Radiology 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
07/15/2019 Radiology 12-326 Complete NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs
03/31/2006 Radiology 12-136 Complete ISO 9236-1 Second edition 2004-02-01 Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
08/14/2015 Radiology 12-291 Complete IEC 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
06/07/2021 Radiology 12-340 Complete IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
08/06/2013 Radiology 12-205 Complete IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
08/06/2013 Radiology 12-211 Complete IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
08/20/2012 Radiology 12-249 Complete IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems
03/14/2011 Radiology 12-217 Complete IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
07/06/2020 Radiology 12-330 Complete NEMA Standards Publication XR 28-2018 Supplemental Requirements for User Information and System Function Related to Dose in CT
10/04/2010 Radiology 12-215 Complete IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
03/16/2012 Radiology 12-106 Complete ISO 17526 First edition 2003-06-15 Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
06/07/2021 Radiology 12-337 Complete NEMA NU 1-2018 Performance Measurements of Gamma Cameras
12/19/2007 Radiology 12-172 Complete ISO 14880-3:2006 Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
12/19/2007 Radiology 12-173 Complete ISO 14880-4:2006 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
12/19/2007 Radiology 12-176 Complete IEC 61223-3-2 Second eidtion 2007-07 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
03/16/2012 Radiology 12-246 Complete ISO 21254-2 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination
03/16/2012 Radiology 12-245 Complete ISO 21254-1 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
03/16/2012 Radiology 12-117 Complete ISO 15367-1 First edition 2003-09-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects
08/21/2017 Radiology 12-306 Complete NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
07/12/1999 Radiology 12-51 Complete IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
01/14/2019 Radiology 12-323 Complete ISO 11990 Third edition 2018-08 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
01/30/2014 Radiology 12-262 Complete ISO 11670 Second edition 2003-04-01 Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)]
06/27/2016 Radiology 12-297 Complete ANSI IES RP-27.1-2015 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
06/27/2016 Radiology 12-298 Complete NEMA MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
03/16/2012 Radiology 12-134 Complete ISO 11146-1 First edition 2005-01-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
07/09/2014 Radiology 12-194 Complete ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
04/04/2016 Radiology 12-196 Complete NEMA MS 2-2008 (R2020) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
04/04/2016 Radiology 12-288 Complete NEMA MS 9-2008 (R2020) Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
03/14/2011 Radiology 12-221 Complete IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
03/16/2012 Radiology 12-142 Complete ISO 11146-2 First edition 2005-02-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
03/16/2012 Radiology 12-143 Complete ISO 15367-2 First edition 2005-03-15 Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
03/16/2012 Radiology 12-248 Complete ISO 21254-3 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
03/16/2012 Radiology 12-174 Complete ISO 13697 First edition 2006-05-15 Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components
08/14/2015 Radiology 12-289 Complete IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
03/31/2006 Radiology 12-137 Complete ISO 4090 Third eidition 2001-08-15 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
03/31/2006 Radiology 12-138 Complete ISO 5799 Second edition 1991-08-01 Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
10/04/2004 Radiology 12-116 Complete ISO 13696:2002 Optics and optical instruments -- Test methods for radiation scattered by optical components
01/30/2014 Radiology 12-259 Complete IEC 61674 Edition 2.0 2012-11 Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
06/07/2018 Radiology 12-314 Complete ISO 11554 Fourth edition 2017-07 Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics
01/14/2014 Radiology 12-268 Complete IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
07/09/2014 Radiology 12-279 Complete IEC 62127-03 Edition 1.1 2013-05 Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
06/27/2016 Radiology 12-301 Complete IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
11/08/2005 Radiology 12-6 Complete IEC 60806 First edition 1984-01 Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
06/27/2016 Radiology 12-294 Complete IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
04/04/2016 Radiology 12-188 Complete NEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
04/04/2016 Radiology 12-187 Complete NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
12/04/2017 Radiology 12-307 Complete AAMI RT2:2017 Radiation therapy readiness check
06/27/2016 Radiology 12-293 Complete IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
05/29/2023 Radiology 12-350 Complete IEC 60806 Edition 2.0 2022-11 Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis
09/17/2018 Radiology 12-318 Complete IEC 60601-2-64 Edition 1.0 2014-09 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
09/17/2018 Radiology 12-320 Complete IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
06/07/2021 Radiology 12-336 Complete IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
12/19/2007 Radiology 12-171 Complete ISO 14880-2:2006 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
03/16/2012 Radiology 12-175 Complete ISO 24013 First edition 2006-11-15 Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
06/07/2018 Radiology 12-312 Complete IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
06/07/2018 Radiology 12-313 Complete IEC TS 62462 Edition 2.0 2017-07 Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
01/30/2014 Radiology 12-59 Complete IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/30/2014 Radiology 12-264 Complete NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
12/18/2023 Radiology 12-352 Complete NEMA PS 3.1 - 3.20 2023e Digital Imaging and Communications in Medicine (DICOM) Set
12/19/2022 Radiology 12-349 Complete NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set
12/23/2019 Radiology 12-329 Complete IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
06/07/2018 Radiology 12-315 Complete NEMA MS 8-2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
05/29/2023 Radiology 12-351 Complete IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
01/27/2015 Radiology 12-230 Complete NEMA XR 24-2008 (R2014) Primary user controls for interventional angiography x-ray equipment
01/27/2015 Radiology 12-286 Complete NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
05/29/2023 Radiology 12-347 Complete IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
05/27/2005 Radiology 12-121 Complete IEC 61847: 1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
01/14/2019 Radiology 12-322 Complete NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
12/19/2022 Radiology 12-346 Complete ISO 12005 Third edition 2022-05 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
01/14/2019 Radiology 12-102 Complete ANSI IES RP-27.2-00/R17 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
01/14/2019 Radiology 12-321 Complete ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
12/23/2019 Radiology 12-309 Complete IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
12/23/2019 Radiology 12-327 Complete ISO 11551 Third eidtion 2019-10 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
12/23/2019 Radiology 12-328 Complete IEC 61223-3-5 Edition 2.0 2019-09 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
01/14/2019 Radiology 12-324 Complete ISO 13694 Third edition 2018-11 Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
 
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