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U.S. Department of Health and Human Services

Recognized Consensus Standards
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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 16-229 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
06/07/2021 Orthopedic 11-383 ASTM F3143-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-124 CIE ISO 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers
12/23/2019 Materials 8-505 ISO 6474-2 Second edition 2019-03 Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
12/23/2019 Materials 8-507 ASTM F688-19 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
08/14/2015 Software/
Informatics		 13-76 ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
03/16/2012 Radiology 12-177 UL 122-2007 (R2011) Standard for Photographic Equipment - Ed. 5.0
03/16/2012 Radiology 12-241 IEC 62274 First Edition 2005-05 Medical electrical equipment - Safety of radiotherapy record and verify systems
08/06/2013 Radiology 12-253 IEC 60976 Edition 2.0 2007-10 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
08/06/2013 Radiology 12-255 IEC 60601-2-11 Edition 3.0 2013-01 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
07/15/2019 Sterility 14-531 ANSI AAMI ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
07/06/2020 Sterility 14-542 ASTM ISO 52628 Second edition 2020-04 Standard practice for dosimetry in radiation processing
09/09/2008 Software/
Informatics		 13-18 CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System
01/14/2019 InVitro Diagnostics 7-139 CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
07/06/2020 Materials 8-532 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 ASTM ISO 52907: First Edition 2019-11 Additive Manufacturing - Feedstock materials - Methods to characterize metal powders
12/21/2020 Biocompatibility 2-282 ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
07/15/2019 Anesthesiology 1-126 ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
07/15/2019 Materials 8-518 ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
08/06/2013 Software/
Informatics		 13-49 IEEE ISO 11073-20101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
01/30/2014 Radiology 12-228 IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
01/30/2014 Radiology 12-261 IEC ISO 10918-1 First edition 1994-02-15 Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
01/30/2014 Radiology 12-267 IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment - Coordinates, movements, and scales
01/14/2019 Anesthesiology 1-138 ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
06/07/2021 Radiology 12-339 IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
01/14/2019 Dental/
ENT		 4-250 ISO 7494-1 Third edition 2018-06 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
01/14/2019 Dental/
ENT		 4-251 ANSI ADA Standard No. 69-2017 Dental Ceramic
ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-125 CIE ISO 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		 9-127 CIE ISO 11664-4 First edition 2019-06 Colorimetry - Part 4: CIE 1976 L*a*b* colour space
08/06/2013 Software/
Informatics		 13-56 IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
08/21/2017 Software/
Informatics		 13-67 IEEE ISO 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
07/15/2019 Materials 8-503 ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
07/15/2019 Materials 8-509 ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
10/04/2010 Radiology 12-213 IEC 62220-1-2 Edition 1.0 2007-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
10/04/2010 Radiology 12-214 IEC 62220-1-3 Edition 1.0 2008-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
07/09/2014 Radiology 12-280 IEC 62555 Edition 1.0 2013-11 Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
08/14/2015 Radiology 12-290 IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
07/15/2019 Materials 8-493 ISO 13779-2 Third edition 2018-12 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
07/15/2019 Materials 8-506 ASTM F2516-18 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-68 ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-111 ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods
01/14/2019 Orthopedic 11-342 ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
07/06/2020 Tissue Engineering 15-59 ASTM F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
12/21/2020 Dental/
ENT		 4-268 ANSI ADA Standard No. 32-2017 Orthodontic Wires
ISO 15841 Second edition 2014-08 Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
07/15/2019 Sterility 14-529 ANSI AAMI ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
12/23/2019 Materials 8-522 ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
07/15/2019 Sterility 14-530 ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
07/06/2020 Materials 8-534 ASTM ISO 52911-1: First Edition 2019-07 Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals
07/15/2019 Orthopedic 11-357 ISO 15142-3 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments
07/06/2020 Sterility 14-545 ASTM ISO 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
07/06/2020 Sterility 14-549 ASTM F3004-13 (Reapproved 2020) Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
08/21/2017 Biocompatibility 2-246 ASTM F1877-16 Standard Practice for Characterization of Particles
08/06/2013 General Plastic Surgery/
General Hospital		 6-296 ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
01/30/2014 General Plastic Surgery/
General Hospital		 6-306 ASTM F1671/F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
07/06/2020 Materials 8-535 ASTM ISO 52911-2: First Edition 2019-09 Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers
07/06/2020 Materials 8-536 ASTM ISO 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
07/06/2020 Tissue Engineering 15-61 ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
12/23/2019 Materials 8-523 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
07/09/2014 Radiology 12-275 IEC 61161 Edition 3.0 2013-01 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
07/09/2014 Radiology 12-281 IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-121 ANSI AAMI IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16 Edition 5.0 2018-4 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
12/23/2019 Radiology 12-328 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 Ophthalmic 10-114 ANSI Z80.28-2017 American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
01/14/2019 Ophthalmic 10-115 ANSI Z80.29-2015 (R2020) American National Standard for Ophthalmics - Accomodative Intraocular Lenses
01/14/2019 Software/
Informatics		 13-106 IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
01/14/2019 Software/
Informatics		 13-107 IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
ISO 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
09/17/2018 Sterility 14-513 ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
01/30/2014 Materials 8-358 ASTM F1855-00 (Reapproved 2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
07/15/2019 Tissue Engineering 15-57 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
12/23/2019 Orthopedic 11-360 ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
12/23/2019 Radiology 12-329 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
07/09/2014 Radiology 12-283 ISO 12609-2 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
03/14/2011 Radiology 12-226 IEC 61223-2-6 Second Edition 2006-11 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
03/16/2012 Radiology 12-105 NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
01/14/2019 Cardiovascular 3-158 ASTM F3320-18 Standard Guide forCoating Characterization of Drug Coated Balloons
01/14/2019 Dental/
ENT		 4-255 ANSI ADA Standard No. 131-2015 Dental CAD/CAM Machinable Zirconia Blanks
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 Orthopedic 11-355 ISO 15142-1 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails
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.
07/15/2019 Materials 8-504 ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
09/17/2018 Orthopedic 11-327 ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
06/07/2018 Biocompatibility 2-249 ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
09/17/2018 Orthopedic 11-340 ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
07/06/2020 ObGyn/
Gastroenterology/
Urology		 9-126 CIE ISO 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
07/06/2020 Cardiovascular 3-167 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 Cardiovascular 3-164 ASTM F1830-19 Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
03/16/2012 Radiology 12-115 ISO 13695:2004 Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
12/23/2016 Radiology 12-303 IEC 61303 Edition 1.0 1994-09 Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
12/23/2016 Radiology 12-304 IEC 60731 Edition 3.1 2016-04 Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
06/27/2016 Materials 8-426 ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
04/04/2016 Orthopedic 11-299 ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
06/07/2021 Radiology 12-337 NEMA NU 1-2018 Performance Measurements of Gamma Cameras
12/23/2019 Cardiovascular 3-162 ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
12/21/2020 Sterility 14-554 ASTM F17-20 Standard Terminology Relating to Flexible Barrier Packaging
12/23/2019 Materials 8-521 ASTM F2313-18 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
07/06/2020 Sterility 14-539 ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
07/06/2020 Materials 8-529 ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
12/23/2019 Materials 8-508 ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
12/23/2019 Sterility 14-538 ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
 
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