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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/19/2022 Cardiovascular 3-183 Complete ISO 11658 First edition 2012-05-15 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
ANSI AAMI ISO 11658: 2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
12/19/2022 Dental/
ENT		 4-294 Complete ANSI ADA Standard No. 139-2020 Dental Base Polymers
12/19/2022 Dental/
ENT		 4-295 Complete ANSI ADA Standard No. 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
12/19/2022 Dental/
ENT		 4-296 Complete ISO 9873 Fourth edition 2019-03 Dentistry - Intra-oral mirrors
ANSI ADA Standard No. 191-2020 Intra-Oral Mirrors
12/19/2022 Dental/
ENT		 4-297 Complete ISO 20126 Third edition 2022-03 Dentistry - Manual toothbrushes - General requirements and test methods
12/19/2022 General I (QS/
RM)		 5-135 Complete ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
12/19/2022 General I (QS/
RM)		 5-136 Complete ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
12/19/2022 General I (QS/
RM)		 5-137 Complete IEC TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
12/19/2022 General I (QS/
RM)		 5-138 Complete AAMI TIR66: 2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/19/2022 General I (QS/
RM)		 5-139 Complete ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
12/19/2022 General I (QS/
RM)		 5-140 Complete ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
12/19/2022 General I (QS/
RM)		 5-141 Complete ASME V&V 20-2009 (R2021) Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
12/19/2022 General II (ES/
EMC)		 19-48 Complete IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
12/19/2022 General Plastic Surgery/
General Hospital		 6-483 Complete IEC 60601-2-35 Edition 2.0 2020-09 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
12/19/2022 General Plastic Surgery/
General Hospital		 6-484 Complete ASTM F3502-22a Standard Specification for Barrier Face Coverings
12/19/2022 General Plastic Surgery/
General Hospital		 6-485 Complete ISO 7886-4 Second Edition 2018-11 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
12/19/2022 InVitro Diagnostics 7-313 Complete CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
12/19/2022 InVitro Diagnostics 7-314 Partial CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
12/19/2022 Materials 8-594 Complete ISO 5832-6 Third Edition 2022-03 Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
12/19/2022 Materials 8-595 Complete ISO 5832-5 Fourth Edition 2022-03 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
12/19/2022 Materials 8-596 Complete ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
12/19/2022 Nanotechnology 18-21 Complete ISO TS 80004-6 Second edition 2021-03 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
12/19/2022 Nanotechnology 18-22 Complete ISO 17200 First edition 2020-09 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-140 Partial ISO 8637-2 First Edition 2018-07 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ANSI AAMI ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-141 Complete ISO 8637-3 First Edition 2018-07 Extracorporeal systems for blood purification - Part 3: Plasmafilters
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-142 Complete ASTM D1894-14 Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-144 Complete ISO 20697 First edition 2018-06; Corrected 2018-09 Sterile drainage catheters and accessory devices for single use
12/19/2022 Ophthalmic 10-132 Partial ISO 10942 Third edition 2022-01 Ophthalmic instruments - Direct ophthalmoscopes
12/19/2022 Ophthalmic 10-133 Complete ISO 11979-10 Second edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.
12/19/2022 Orthopedic 11-394 Complete ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
12/19/2022 Orthopedic 11-395 Complete ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
12/19/2022 Orthopedic 11-396 Complete ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022] Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
12/19/2022 Orthopedic 11-397 Complete ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
12/19/2022 Orthopedic 11-398 Complete ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
12/19/2022 Physical Medicine 16-233 Complete ISO 16840-10 Second edition 2021-06 Corrected version 2022-01 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
12/19/2022 Radiology 12-346 Complete ISO 12005 Third edition 2022-05 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
12/19/2022 Radiology 12-349 Complete NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set
12/19/2022 Software/
Informatics		 13-121 Complete ANSI AAMI UL 2800-1:2022 Standard for Medical Device Interoperability
12/19/2022 Software/
Informatics		 13-122 Complete IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022 Software/
Informatics		 13-123 Complete ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
12/19/2022 Software/
Informatics		 13-124 Complete AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
12/19/2022 Software/
Informatics		 13-125 Complete ANSI AAMI UL 2800-1-1:2022 Standard for Risk Concerns for Interoperable Medical Products
12/19/2022 Software/
Informatics		 13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
12/19/2022 Software/
Informatics		 13-127 Complete ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
12/19/2022 Software/
Informatics		 13-128 Complete IEEE UL Std 2621.2-2022 Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions
12/19/2022 Sterility 14-580 Complete ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
12/19/2022 Sterility 14-581 Complete ASTM F2638-22 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
12/19/2022 Sterility 14-582 Complete AAMI ISO TIR11137-4:2022 Sterilization of health care products - Radiation - Part 4: Guidance on process control
ISO TS 11137-4 First edition 2020-06 Sterilization of health care products - Radiation - Part 4: Guidance on process control
12/19/2022 Sterility 14-583 Complete ANSI AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
05/30/2022 Anesthesiology 1-152 Complete ISO 80601-2-87 First edition 2021-04 Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
 
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