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U.S. Department of Health and Human Services

Recognized Consensus Standards

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FR List Publication Date from: 07/16/2019 FR List Publication Date to: 12/24/2019
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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
12/23/2019 Anesthesiology 1-145 ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
12/23/2019 Biocompatibility 2-271 USP 42-NF37:2019 <88> Biological Reactivity Tests, In Vivo
12/23/2019 Biocompatibility 2-269 USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/23/2019 Biocompatibility 2-270 USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro - Elution Test
12/23/2019 Biocompatibility 2-272 USP 42-NF37:2019 <151> Pyrogen Test (USP Rabbit Test)
12/23/2019 Cardiovascular 3-161 ISO 14117 Second edition 2019-09 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.
12/23/2019 Cardiovascular 3-162 ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
12/23/2019 Cardiovascular 3-163 ISO 18242 First edition 2016-09-01 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps.
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
4-260 ANSI ASA S12.2-2019 American National Standard Criteria for Evaluating Room Noise
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 General I (QS/
RM)
5-124 ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols
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 Edtion 2019-12 Medical devices - Application of risk management to medical devices
12/23/2019 General II (ES/
EMC)
19-33 IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/23/2019 General II (ES/
EMC)
19-32 IEC 62133-1 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
12/23/2019 General II (ES/
EMC)
19-13 IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
12/23/2019 General Plastic Surgery/
General Hospital
6-438 IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
12/23/2019 General Plastic Surgery/
General Hospital
6-434 USP 42-NF37:2019 Sterile Water for Irrigation
12/23/2019 General Plastic Surgery/
General Hospital
6-435 USP 42-NF37:2019 Heparin Lock Flush Solution
12/23/2019 General Plastic Surgery/
General Hospital
6-436 USP 42-NF37:2019 Absorbable Surgical Suture
12/23/2019 General Plastic Surgery/
General Hospital
6-431 USP 42-NF37:2019 <881> Tensile Strength
12/23/2019 General Plastic Surgery/
General Hospital
6-432 USP 42-NF37:2019 <861> Sutures - Diameter
12/23/2019 General Plastic Surgery/
General Hospital
6-428 USP 42-NF37:2019 Sodium Chloride Irrigation
12/23/2019 General Plastic Surgery/
General Hospital
6-429 USP 42-NF37:2019 Sodium Chloride Injection
12/23/2019 General Plastic Surgery/
General Hospital
6-437 ISO 23907-2 First edition 2019-11 Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
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 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
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 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
6-430 USP 42-NF37:2019 Nonabsorbable Surgical Suture
12/23/2019 General Plastic Surgery/
General Hospital
6-433 USP 42-NF37:2019 <871> Sutures - Needle Attachment
12/23/2019 InVitro Diagnostics 7-294 CLSI M100, 29th ed. January 2019 (Replaces M100 28th ed). Performance Standards for Antimicrobial Susceptibility Testing
12/23/2019 InVitro Diagnostics 7-295 CLSI M52, 1st ed. August 2015. Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
12/23/2019 InVitro Diagnostics 7-293 CLSI QMS01, 5th ed. June 2019 (Replaces QMS01-A4) A Quality Management System Model for Laboratory Services.
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 8-507 ASTM F688-19 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
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 8-484 ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
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 8-523 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
12/23/2019 Materials 8-524 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 Materials 8-501 ISO 5834-1 Fourth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
12/23/2019 Materials 8-491 ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
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 8-500 ISO 5832-12 Third edition 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
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 8-481 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 8-508 ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
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 8-521 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
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
12/23/2019 Materials 8-519 ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
12/23/2019 Materials 8-520 ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
12/23/2019 ObGyn/
Gastroenterology/
Urology
9-123 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 11-361 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 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 Orthopedic 11-360 ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
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.
12/23/2019 Physical Medicine 16-208 ANSI RESNA 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 16-212 ANSI RESNA 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 16-218 ANSI RESNA 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 16-220 ANSI RESNA 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 ANSI RESNA 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 16-223 ANSI RESNA 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 16-227 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
12/23/2019 Physical Medicine 16-215 ANSI RESNA 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 ANSI RESNA 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 ANSI RESNA 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 16-222 ANSI RESNA 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 16-224 ANSI RESNA 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 ANSI RESNA 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 16-207 ANSI RESNA 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 16-209 ANSI RESNA 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 ANSI RESNA 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 ANSI RESNA 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 16-219 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
12/23/2019 Physical Medicine 16-213 ANSI RESNA 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 ANSI RESNA 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 Radiology 12-317 IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including: Amendment 2 (2018)]
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
12/23/2019 Radiology 12-309 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 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 12-204 IEC 60601-2-28 Edition 2.0 2010-03 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 12-296 IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
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)]
12/23/2019 Software/
Informatics
13-110 IEEE ISO 11073-10101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature [Including AMENDMENT 1 (2017)]
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
12/23/2019 Software/
Informatics
13-112 AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
12/23/2019 Sterility 14-529 ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
12/23/2019 Sterility 14-530 ASTM ISO 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
12/23/2019 Sterility 14-531 USP 42-NF37:2019 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/23/2019 Sterility 14-532 USP 42-NF37:2019 <71> Sterility Tests
12/23/2019 Sterility 14-533 USP 42-NF37:2019 <85> Bacterial Endotoxins Test
12/23/2019 Sterility 14-534 USP 42-NF37:2019 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/23/2019 Sterility 14-535 USP 42-NF37:2019 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/23/2019 Sterility 14-536 USP 42-NF37:2019 <55> Biological Indicators -- Resistance Performance Tests
12/23/2019 Sterility 14-537 USP 42-NF37:2019 <1229.5> Biological Indicators for Sterilization
12/23/2019 Sterility 14-538 ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
12/23/2019 Sterility 14-528 ANSI AAMI ISO TIR 11139:2006 Sterilization of health care products - Vocabulary
ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
 
 
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