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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2019 Materials 8-523 Complete ASTM F3275-19 Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
12/23/2019 Materials 8-524 Complete ASTM F3276-19 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
12/23/2019 ObGyn/
Gastroenterology/
Urology		 9-123 Partial ISO 8600-3 Second edition 2019-08 Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
12/23/2019 Orthopedic 11-360 Complete ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
12/23/2019 Orthopedic 11-361 Complete ISO 14243-5 First edition 2019-05 Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
12/23/2019 Orthopedic 11-362 Complete ISO 22622 First edition 2019-07 Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
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 16-208 Complete RESNA ANSI 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 16-209 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 16-211 Complete RESNA ANSI 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 16-212 Complete RESNA ANSI 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 16-213 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
12/23/2019 Physical Medicine 16-215 Complete RESNA ANSI 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 16-216 Complete RESNA ANSI 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 16-217 Complete RESNA ANSI 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 16-218 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
12/23/2019 Physical Medicine 16-219 Complete RESNA ANSI 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 16-220 Complete RESNA ANSI 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 16-221 Complete RESNA ANSI 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 16-222 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 16-223 Complete RESNA ANSI 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 16-224 Complete RESNA ANSI 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 16-225 Complete RESNA ANSI 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 16-226 Complete RESNA ANSI 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 16-227 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 16-228 Complete RESNA ANSI 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 16-229 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 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)]
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
12/23/2019 Software/
Informatics		 13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
12/23/2019 Software/
Informatics		 13-112 Complete AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
12/23/2019 Sterility 14-538 Complete ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
07/06/2020 Anesthesiology 1-146 Complete ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
07/06/2020 Biocompatibility 2-273 Complete ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/06/2020 Biocompatibility 2-274 Complete ASTM F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/06/2020 Biocompatibility 2-275 Complete ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
07/06/2020 Biocompatibility 2-276 Partial ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
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
07/06/2020 Cardiovascular 3-155 Complete IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
07/06/2020 Cardiovascular 3-164 Complete ASTM F1830-19 (Reapproved 2024) Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps
07/06/2020 Cardiovascular 3-165 Complete ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
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
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
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
07/06/2020 General I (QS/
RM)		 5-127 Complete ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL) Shipment
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)		 5-129 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
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
07/06/2020 General Plastic Surgery/
General Hospital		 6-178 Partial ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
07/06/2020 General Plastic Surgery/
General Hospital		 6-439 Complete ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
07/06/2020 General Plastic Surgery/
General Hospital		 6-440 Partial ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves
07/06/2020 General Plastic Surgery/
General Hospital		 6-441 Complete ISO 7886-3 Second edition 2020-05 Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
07/06/2020 General Plastic Surgery/
General Hospital		 6-442 Partial ASTM D6977-19(2023) Standard Specification for Polychloroprene Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital		 6-443 Partial ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
07/06/2020 General Plastic Surgery/
General Hospital		 6-444 Complete ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves
07/06/2020 General Plastic Surgery/
General Hospital		 6-445 Partial ASTM D5250-19(2023) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital		 6-446 Partial ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital		 6-447 Complete ISO 8536-4 Sixth edition 2019-09 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
07/06/2020 InVitro Diagnostics 7-297 Complete ISO TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
07/06/2020 InVitro Diagnostics 7-298 Complete CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
07/06/2020 Materials 8-526 Complete ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance
07/06/2020 Materials 8-527 Complete ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments
07/06/2020 Materials 8-528 Complete ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
07/06/2020 Materials 8-529 Complete ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
07/06/2020 Materials 8-531 Complete ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
07/06/2020 Materials 8-532 Complete ASTM F3335-20 Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
07/06/2020 Materials 8-533 Complete ISO ASTM 52907: First Edition 2019-11 Additive Manufacturing - Feedstock materials - Methods to characterize metal powders
07/06/2020 Materials 8-534 Complete ISO ASTM 52911-1: First Edition 2019-07 Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals
07/06/2020 Materials 8-535 Complete ISO ASTM 52911-2: First Edition 2019-09 Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers
07/06/2020 Materials 8-536 Complete ISO ASTM 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
07/06/2020 Nanotechnology 18-15 Complete ASTM E3025-16 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
07/06/2020 Nanotechnology 18-16 Complete ISO TS 21362 First edition 2018-06 Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-124 Complete CIE ISO 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-125 Complete ISO CIE 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 Colorimetry - Part 2: CIE standard illuminants
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-126 Complete ISO CIE 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-127 Complete ISO CIE 11664-4 First edition 2019-06 Colorimetry - Part 4: CIE 1976 L*a*b* colour space
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-128 Complete ISO CIE 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-129 Complete ISO CIE 61966-2-1 First edition 1999-10 Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
07/06/2020 Orthopedic 11-363 Complete ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
07/06/2020 Orthopedic 11-364 Complete ISO 14243-1 Second edition 2009-11-15 Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/06/2020 Orthopedic 11-365 Complete ASTM F1800-19 e1 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
07/06/2020 Orthopedic 11-366 Complete ASTM F2381-19 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
07/06/2020 Orthopedic 11-367 Complete ISO 14243-3 Second edition 2014-11-01 Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/06/2020 Orthopedic 11-368 Complete ASTM F3334-19 Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
07/06/2020 Orthopedic 11-369 Complete ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
07/06/2020 Radiology 12-325 Complete NEMA Standards Publication XR 25 -2019 Computed Tomography Dose Check
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
07/06/2020 Radiology 12-331 Complete NEMA Standards Publication MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
07/06/2020 Radiology 12-332 Complete IEC 62464-1 Edition 2.0 2018-12 Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
07/06/2020 Radiology 12-333 Complete IEC TR 63183 Edition 1.0 2019-12 Guidance on error and warning messages for software used in radiotherapy
07/06/2020 Radiology 12-334 Complete AAMI RT3:2020 Radiation therapy machine characterization
07/06/2020 Software/
Informatics		 13-113 Complete IEEE Std 11073-20601-2019 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
07/06/2020 Software/
Informatics		 13-114 Complete IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
07/06/2020 Software/
Informatics		 13-115 Complete ISO IEC IEEE 29119-1 First edition 2013-09-01 Software and systems engineering - Software testing - Part 1: Concepts and definitions
07/06/2020 Sterility 14-539 Complete ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
 
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