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U.S. Department of Health and Human Services

Recognized Consensus Standards
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12/21/2020 Materials 8-554 ASTM ISO TR 52912 First edition 2020-09 Additive manufacturing - Design - Functionally graded additive manufacturing
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
12/21/2020 ObGyn/
Gastroenterology/
Urology		 9-130 ISO 8600-6 Second edition 2020-09 Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
07/15/2019 Materials 8-496 ISO 5834-4 Second edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
07/06/2020 General Plastic Surgery/
General Hospital		 6-444 ASTM D7103-19 Standard Guide for Assessment of Medical Gloves
12/21/2020 Orthopedic 11-373 ASTM F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint
12/21/2020 Orthopedic 11-370 ISO 14879-1 Second edition 2020-07 Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
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 General I (QS/
RM)		 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
08/06/2013 General I (QS/
RM)		 5-76 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 Medical Electrical Equipment ¿ Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
12/21/2020 General I (QS/
RM)		 5-132 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020 Tissue Engineering 15-65 ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
06/07/2021 Tissue Engineering 15-66 ASTM F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy
07/15/2019 Biocompatibility 2-268 ISO /TS 21726 First edition 2019-02 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
06/27/2016 General Plastic Surgery/
General Hospital		 6-377 ISO 11608-5 First edition 2012-10-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function.
07/06/2020 Anesthesiology 1-146 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
06/07/2021 InVitro Diagnostics 7-307 CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
06/27/2016 General I (QS/
RM)		 5-89 IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020 General II (ES/
EMC)		 19-37 IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
12/21/2020 Materials 8-547 ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
06/27/2016 Materials 8-421 ASTM F629-15 Standard Practice for Radiography of Cast Metallic Surgical Implants
07/15/2019 Radiology 12-326 NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs
07/06/2020 General I (QS/
RM)		 5-126 ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-135 ANSI AAMI ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
ISO 23500-3 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-136 ANSI AAMI ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
ISO 23500-4 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
01/14/2019 Radiology 12-323 ISO 11990 Third edition 2018-08 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
01/14/2019 Radiology 12-324 ISO 13694 Third edition 2018-11 Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
12/23/2019 Materials 8-480 ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
12/23/2019 Materials 8-481 ASTM F1314-18 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
12/23/2019 Materials 8-484 ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
08/21/2017 General Plastic Surgery/
General Hospital		 6-388 ANSI AAMI IEC 60601-2-21:2009/A1:2016 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
IEC 60601-2-21 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
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
06/07/2021 Orthopedic 11-379 ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
06/07/2021 General Plastic Surgery/
General Hospital		 6-463 IEC 60601-2-21 Edition 3.0 2020-09 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
07/06/2020 General I (QS/
RM)		 5-127 ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL) Shipment
07/06/2020 General I (QS/
RM)		 5-128 ISTA 3E 2017 Similar Packaged-Products in Unitized Loads of Truckload Shipment
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
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-138 ISO 20695 First edition 2020-03 Enteral feeding systems - Design and testing
12/21/2020 Dental/
ENT		 4-267 ANSI ADA Standard No. 105-2010 (R2015) Orthodontic Elastomeric Materials
ISO 21606 First edition 2007-06 Dentistry - Elastomeric auxiliaries for use in orthodontics
12/21/2020 Ophthalmic 10-121 ISO 16672 Third edition 2020-06 Ophthalmic implants - Ocular endotamponades
08/21/2017 Cardiovascular 3-149 ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
07/15/2019 Materials 8-513 ISO 20160 First edition 2006-05-01 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
07/15/2019 General II (ES/
EMC)		 19-35 UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
01/14/2019 Software/
Informatics		 13-105 ANSI AAMI SW91:2018 Classification of defects in health software
07/15/2019 Materials 8-497 ISO 5834-5 Second edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
07/15/2019 Orthopedic 11-351 ISO 18192-1 Second edition 2011-03-01 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
12/23/2019 Software/
Informatics		 13-112 AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
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
12/21/2020 Materials 8-539 ASTM F139-19 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
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
01/30/2014 Anesthesiology 1-98 ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)]
06/07/2021 Orthopedic 11-384 ASTM F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
06/07/2021 Radiology 12-336 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
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 Anesthesiology 1-148 ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
01/14/2014 Radiology 12-269 IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
12/21/2020 Ophthalmic 10-119 ISO 11979-5 Third edition 2020-09 Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
07/06/2020 Orthopedic 11-364 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)]
01/14/2019 Nanotechnology 18-8 ASTM E2578-07 (Reapproved 2022) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions
01/14/2019 Nanotechnology 18-11 ISO /TR 13121 First edition 2011-05-15 Nanotechnologies - Nanomaterial risk evaluation
01/14/2019 Radiology 12-322 NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
07/15/2019 Tissue Engineering 15-58 ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
07/06/2020 Software/
Informatics		 13-114 IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
07/06/2020 Software/
Informatics		 13-115 IEC IEEE ISO 29119-1 First edition 2013-09-01 Software and systems engineering - Software testing - Part 1: Concepts and definitions
07/06/2020 Materials 8-531 ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
07/15/2019 General I (QS/
RM)		 5-123 ISO 80369-3 First Edition 2016-07-01 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
07/15/2019 Ophthalmic 10-118 ANSI Z80.38-2017 (R2021) American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery
07/09/2014 General II (ES/
EMC)		 19-9 IEC 60601-1-10 Edition 1.1 2013-11 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
01/30/2014 General Plastic Surgery/
General Hospital		 6-321 IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
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
12/23/2016 General I (QS/
RM)		 5-114 ANSI AAMI IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
12/23/2019 General I (QS/
RM)		 5-125 ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
07/06/2020 Radiology 12-325 NEMA Standards Publication XR 25 -2019 Computed Tomography Dose Check
12/21/2020 Materials 8-541 ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
12/23/2019 Orthopedic 11-362 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 General Plastic Surgery/
General Hospital		 6-424 ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
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
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
12/23/2019 Orthopedic 11-361 ISO 14243-5 First edition 2019-05 Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
06/07/2021 Tissue Engineering 15-67 ASTM F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
01/30/2014 Cardiovascular 3-118 ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
06/07/2018 ObGyn/
Gastroenterology/
Urology		 9-114 IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
12/21/2020 Sterility 14-550 ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
06/07/2021 Orthopedic 11-382 ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
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)
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)
01/14/2019 Dental/
ENT		 4-249 ANSI ADA Standard No. 19-2018 Elastometric Impression Materials
 
 
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