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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/15/2019 InVitro Diagnostics 7-287 Complete CLSI M44-S3 (2018) Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
01/27/2015 Radiology 12-286 Complete NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
12/23/2016 Physical Medicine 16-199 Complete ISO 7176-28 First edition 2012-10-1 Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
06/07/2018 Physical Medicine 16-201 Complete 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)]
07/15/2019 Physical Medicine 16-206 Complete ISO 7176 - 30 First edition 2018-12 Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
01/30/2014 Physical Medicine 16-167 Complete ISO 7176-9 Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
04/04/2016 Physical Medicine 16-197 Complete 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 Complete ISO 7176-7 First Edition 1998-05-15 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
01/14/2019 Physical Medicine 16-204 Complete ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs
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
01/30/2014 Physical Medicine 16-162 Complete ISO 7176-4 Third edition 2008-10-01 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
08/06/2013 Physical Medicine 16-192 Complete ISO 7176-3 Third edition 2012-12-15 Wheelchairs - Part 3: Determination of effectiveness of brakes
05/29/2023 Physical Medicine 16-235 Complete ISO 7176-25 Second Edition 2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
08/14/2015 Physical Medicine 16-194 Complete ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
04/04/2016 Physical Medicine 16-198 Complete ISO 7176-22 Second edition 2014-09-01 Wheelchairs - Part 22: Set-up procedures
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
09/17/2018 Physical Medicine 16-202 Complete ISO 7176-2 Third edition 2017-10 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
05/29/2023 Physical Medicine 16-236 Complete ISO 7176-19 Third Edition 2022 Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles
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 16-165 Complete 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
05/29/2023 Physical Medicine 16-234 Complete ISO 7176-14 Third Edition 2022 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
01/30/2014 Physical Medicine 16-25 Complete ISO 7176-13 First edition 1989-08-01 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
08/06/2013 Physical Medicine 16-190 Complete ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies
01/30/2014 Physical Medicine 16-164 Complete ISO 7176-10 Second edition 2008-11-01 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
04/04/2016 Physical Medicine 16-195 Complete ISO 7176-1 Third edition 2014-10-01 Wheelchairs - Part 1: Determination of static stability
12/19/2022 Physical Medicine 16-233 Complete ISO 16840-10 Second edition 2021-06 Corrected version 2022-01 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
03/18/2009 InVitro Diagnostics 7-180 Complete CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
09/17/2018 Orthopedic 11-336 Complete ISO 17853 Third edition 2011-03-01 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
12/18/2023 Sterility 14-597 Complete AAMI ANSI ST108:2023 Water for the processing of medical devices
03/18/2009 InVitro Diagnostics 7-185 Complete CLSI M41-A Viral Culture; Approved Guideline.
12/23/2019 InVitro Diagnostics 7-295 Complete CLSI M52, 1st ed. August 2015 (Reaffirmed: January 2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
07/15/2019 InVitro Diagnostics 7-289 Partial CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
01/30/2014 InVitro Diagnostics 7-210 Partial CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
01/15/2013 Software/
Informatics		 13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
03/16/2012 InVitro Diagnostics 7-225 Complete CLSI GP34-A (Replaces GP34-P) Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
01/14/2019 InVitro Diagnostics 7-139 Complete CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
08/14/2015 InVitro Diagnostics 7-253 Complete CLSI EP15-A3 (Reaffirmed: September 2019) User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
01/30/2014 InVitro Diagnostics 7-152 Complete CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
05/05/2010 InVitro Diagnostics 7-207 Complete CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
07/09/2014 Radiology 12-275 Complete IEC 61161 Edition 3.0 2013-01 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
07/09/2014 Radiology 12-280 Complete IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
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
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
05/27/2005 Radiology 12-121 Complete IEC 61847: 1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
01/30/2014 Radiology 12-228 Complete IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
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
09/09/2008 ObGyn/
Gastroenterology/
Urology		 9-7 Complete IEC 61846 First edition 1998-04 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
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
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
 
 
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