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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
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
12/21/2020 InVitro Diagnostics 7-301 CLSI GP42 7th Edition Collection of Capillary Blood Specimens
01/14/2019 Software/
Informatics
13-105 ANSI AAMI SW91:2018 Classification of defects in health software
12/23/2019 Software/
Informatics
13-111 IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
06/07/2021 Orthopedic 11-376 ASTM F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
12/21/2020 InVitro Diagnostics 7-302 CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
12/21/2020 InVitro Diagnostics 7-304 CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
12/21/2020 InVitro Diagnostics 7-305 ISO 17511 Second edition 2020-04 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
12/21/2020 Materials 8-537 ASTM F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
06/27/2016 Materials 8-217 ASTM F620-11 (Reapproved 2015) Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
12/21/2020 Anesthesiology 1-147 ISO 26825 Second edition 2020-10 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
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
07/15/2019 Orthopedic 11-353 ISO 18192-3 First edition 2017-06 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
07/15/2019 Materials 8-514 ISO 5834-2 Fifth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
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
01/14/2019 Dental/
ENT
4-162 ANSI ASA S3.4-2007 (Reaffirmed 2017) American National Standard Procedure for the Computation of Loudness of Steady Sounds
06/07/2021 Orthopedic 11-377 ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis
12/21/2020 Materials 8-538 ASTM F2759-19 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
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
06/07/2021 Orthopedic 11-378 ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
04/04/2016 Sterility 14-409 ANSI AAMI ISO Standard
ISO 11137-2 Third edition 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
06/07/2021 Orthopedic 11-382 ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
12/23/2019 Anesthesiology 1-102 ISO 80601-2-69 First edition 2014-07-15 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
12/21/2020 Anesthesiology 1-149 ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
08/06/2013 Materials 8-339 ASTM F1091-12 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-137 ANSI AAMI ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
ISO 23500-5 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
07/06/2020 General I (QS/
RM)
5-129 ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
12/21/2020 Ophthalmic 10-119 ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
07/15/2019 General I (QS/
RM)
5-115 ANSI AAMI ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-7 First edition 2016-10-15 Corrected version 2016-12-01 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
06/07/2021 Radiology 12-335 IEC 60336 Edition 5.0 2020-12 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
08/06/2013 Materials 8-338 ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
12/21/2020 Materials 8-540 ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
01/30/2014 Radiology 12-270 IEC 61223-3-5 First edition 2004-08 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 12-102 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 ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
12/23/2019 General Plastic Surgery/
General Hospital
6-425 ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
12/23/2019 Orthopedic 11-360 ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
06/07/2021 InVitro Diagnostics 7-307 CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
01/14/2019 Anesthesiology 1-141 ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
06/07/2021 Orthopedic 11-381 ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
12/23/2019 Materials 8-492 ISO 5832-9 Third edition 2019-02 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
12/23/2019 Materials 8-494 ISO 6474-1 Second edition 2019-03 Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
12/23/2019 Materials 8-498 ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
12/23/2019 Materials 8-499 ASTM F1580-18 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
12/23/2019 Materials 8-500 ISO 5832-12 Third edition 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
07/15/2019 Software/
Informatics
13-108 IEEE Std 11073-20701-2018 Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding
12/23/2019 Materials 8-502 ASTM F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
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
08/21/2017 Software/
Informatics
13-91 IEEE ISO 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
01/14/2019 Dental/
ENT
4-249 ANSI ADA Standard No. 19-2018 Elastometric Impression Materials
07/15/2019 Dental/
ENT
4-258 ANSI ADA Standard No. 160-2020 Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
ISO 10139-2 Third edition 2016-06-15 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
07/06/2020 Radiology 12-332 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 12-334 AAMI RT3:2020 Radiation therapy machine characterization
07/06/2020 Radiology 12-325 NEMA Standards Publication XR 25 -2019 Computed Tomography Dose Check
12/23/2019 Dental/
ENT
4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
07/15/2019 Software/
Informatics
13-109 AAMI ANSI UL 2800-1: 2019 Standard for Safety for Medical Device Interoperability
12/23/2019 General Plastic Surgery/
General Hospital
6-426 ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
12/23/2019 General Plastic Surgery/
General Hospital
6-427 ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
07/06/2020 Cardiovascular 3-165 ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
07/06/2020 Cardiovascular 3-155 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
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
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
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
08/21/2017 General Plastic Surgery/
General Hospital
6-385 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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
04/04/2016 Radiology 12-195 NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
07/09/2014 Radiology 12-273 IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
07/09/2014 Radiology 12-275 IEC 61161 Edition 3.0 2013-01 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
06/27/2016 Dental/
ENT
4-139 ANSI ADA Standard No. 48-2004 (R2015) Visible Light Curing Units
01/14/2019 Dental/
ENT
4-253 ANSI ADA Standard No. 27-2016 Polymer-based Restorative Materials
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
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
07/06/2020 ObGyn/
Gastroenterology/
Urology
9-129 CIE ISO 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)]
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 8-506 ASTM F2516-18 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
12/21/2020 Sterility 14-551 ISO 14160 Third edition 2020-09 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
06/07/2018 Radiology 12-310 IEC 60601-2-63 Edition 1.1 2017-07 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
4-252 ANSI ADA Standard No. 48-2-2010 (R2015) LED Curing Lights
ISO 10650 Second edition 2018-08 Dentistry - Powered polymerization activators
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 8-503 ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
04/04/2016 ObGyn/
Gastroenterology/
Urology
9-113 CEN EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
06/07/2021 ObGyn/
Gastroenterology/
Urology
9-134 ANSI AAMI ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
ISO 23500-2 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
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 16-228 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.
01/14/2019 Cardiovascular 3-126 ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
07/06/2020 InVitro Diagnostics 7-298 CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
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 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
01/14/2019 General I (QS/
RM)
5-122 ASME V&V 40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
12/23/2019 Dental/
ENT
4-262 IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
12/21/2020 ObGyn/
Gastroenterology/
Urology
9-130 ISO 8600-6 Second edition 2020-09 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
 
 
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