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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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03/16/2012 Anesthesiology 1-62 Complete ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
ANSI AAMI ISO 5356-1:2004 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
03/16/2012 Anesthesiology 1-72 Complete ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
03/16/2012 Anesthesiology 1-73 Complete ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
03/16/2012 Anesthesiology 1-75 Complete ISO 5362 Fourth edition 2006-06-01 Anaesthetic Reservoir Bags
ANSI AAMI ISO 5362:2006 Anaesthetic Reservoir Bags
01/30/2014 Anesthesiology 1-81 Complete CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
08/20/2012 Anesthesiology 1-87 Complete IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
01/30/2014 Anesthesiology 1-97 Complete CGA V-7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
07/09/2014 Anesthesiology 1-99 Complete ASTM G175-13 (Reapproved 2021) Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
07/09/2014 Anesthesiology 1-100 Complete CGA V-1:2013 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
07/09/2014 Anesthesiology 1-101 Complete CGA C-9:2013 Standard Color Marking of Compressed Gas Containers for Medical Use
08/14/2015 Anesthesiology 1-103 Complete ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment - Breathing sets and connectors
08/14/2015 Anesthesiology 1-105 Complete ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
04/04/2016 Anesthesiology 1-106 Partial ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
01/14/2019 Anesthesiology 1-114 Complete ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
07/15/2019 Anesthesiology 1-116 Complete ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
01/14/2019 Anesthesiology 1-117 Complete ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
12/23/2016 Anesthesiology 1-118 Complete ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/23/2016 Anesthesiology 1-119 Complete ISO 14408 Third edition 2016-02-15 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
01/14/2019 Anesthesiology 1-120 Complete ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
07/15/2019 Anesthesiology 1-122 Complete ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment-Oropharyngeal airways
08/21/2017 Anesthesiology 1-124 Complete ISO 8835-7 First edition 2011-11-01 Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
07/15/2019 Anesthesiology 1-126 Complete ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
08/21/2017 Anesthesiology 1-127 Complete ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
06/07/2018 Anesthesiology 1-129 Complete ISO 5359 Fourth edition 2014-10-01 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]
06/07/2018 Anesthesiology 1-130 Complete ISO 18082 First edition 2014-06-15 Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]
06/07/2018 Anesthesiology 1-134 Partial ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
06/07/2018 Anesthesiology 1-135 Complete ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
06/07/2018 Anesthesiology 1-136 Complete ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
06/07/2018 Anesthesiology 1-137 Partial ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
01/14/2019 Anesthesiology 1-138 Complete 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
09/17/2018 Anesthesiology 1-139 Partial ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
09/17/2018 Anesthesiology 1-140 Complete ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
01/14/2019 Anesthesiology 1-141 Complete 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)]
07/15/2019 Anesthesiology 1-143 Complete ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
07/15/2019 Anesthesiology 1-144 Complete ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
12/23/2019 Anesthesiology 1-145 Complete ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
07/06/2020 Anesthesiology 1-146 Complete 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
12/21/2020 Anesthesiology 1-147 Complete 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 Anesthesiology 1-148 Complete 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
12/21/2020 Anesthesiology 1-149 Complete ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
12/21/2020 Anesthesiology 1-150 Complete ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract
06/07/2021 Anesthesiology 1-151 Complete ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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
12/19/2022 Anesthesiology 1-153 Complete NFPA 99:2021 Health Care Facilities Code
12/19/2022 Anesthesiology 1-154 Complete ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy
12/19/2022 Anesthesiology 1-155 Complete ISO 10079-2 Fourth edition 2022-03 Medical suction equipment - Part 2: Manually powered suction equipment
12/19/2022 Anesthesiology 1-156 Complete ISO 10079-3 Fourth edition 2022-03 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
12/19/2022 Anesthesiology 1-157 Complete ISO 10079-1 Fourth edition 2022-03 Medical suction equipment - Part 1: Electrically powered suction equipment
12/19/2022 Anesthesiology 1-158 Complete ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements
12/19/2022 Anesthesiology 1-159 Complete ISO 18778 Second edition 2022-06 Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
12/19/2022 Anesthesiology 1-160 Complete ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
05/29/2023 Anesthesiology 1-161 Complete ISO 16628 Second edition 2022-06 Anaesthetic and respiratory equipment - Tracheobronchial tubes
12/18/2023 Anesthesiology 1-162 Complete ISO 10651-4 Second edition 2023-03 Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
12/18/2023 Anesthesiology 1-163 Complete ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
12/18/2023 Anesthesiology 1-164 Complete ISO 5361 Fourth edition 2023-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/18/2023 Anesthesiology 1-165 Complete ISO 80601-2-13 Second edition 2022-04 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
12/18/2023 Anesthesiology 1-166 Complete ISO 11195 Second edition 2018-01 Gas mixers for medical use - Stand-alone gas mixers
05/29/2024 Anesthesiology 1-167 Complete CGA V-5:2019 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
05/29/2024 Anesthesiology 1-168 Complete CGA V-7.1:2021 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
05/29/2024 Anesthesiology 1-169 Complete CGA V-1:2021 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
05/29/2024 Anesthesiology 1-170 Complete CGA C-9:2019 Standard Color Marking of Compressed Gas Containers for Medical Use
05/29/2024 Anesthesiology 1-171 Complete ISO 5367 Sixth edition 2023-07 Anaesthetic and respiratory equipment - Breathing sets and connectors
05/29/2024 Anesthesiology 1-172 Complete ISO 11712 Second edition 2023-11 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
05/29/2024 Anesthesiology 1-173 Partial ISO 18562-1 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
05/29/2024 Anesthesiology 1-174 Complete ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
05/29/2024 Anesthesiology 1-175 Complete ISO 18562-3 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
05/29/2024 Anesthesiology 1-176 Complete ISO 18562-4 Second Edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
05/29/2024 Anesthesiology 1-177 Complete ISO 80601-2-74 Second edition 2021-07 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
05/29/2024 Anesthesiology 1-178 Complete ISO 23747 Second edition 2015-08 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
05/29/2024 Anesthesiology 1-179 Partial ISO 26782 First edition 2009-07 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]
10/07/2024 Anesthesiology 1-180 Complete NFPA 99:2024 Health Care Facilities Code
10/07/2024 Anesthesiology 1-181 Complete ASME PVHO-1-2023 Safety Standard for Pressure Vessels for Human Occupancy
12/23/2016 Biocompatibility 2-93 Complete ASTM F763-04 (Reapproved 2016) Standard Practice for Short-Term Screening of Implant Materials
12/23/2016 Biocompatibility 2-94 Complete ASTM F981-04 (Reapproved 2016) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
01/14/2019 Biocompatibility 2-136 Complete ASTM E1262-88 (Reapproved 2018) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
01/14/2019 Biocompatibility 2-141 Complete ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
01/14/2019 Biocompatibility 2-145 Complete ASTM F1439-03 (Reapproved 2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
08/21/2017 Biocompatibility 2-155 Complete ASTM F2147-01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
07/26/2016 Biocompatibility 2-169 Partial ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ANSI AAMI ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/26/2016 Biocompatibility 2-170 Complete ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
ANSI AAMI ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
07/26/2016 Biocompatibility 2-174 Complete ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
12/23/2016 Biocompatibility 2-189 Complete ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
07/26/2016 Biocompatibility 2-191 Partial ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/26/2016 Biocompatibility 2-213 Complete ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
07/26/2016 Biocompatibility 2-222 Complete ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ANSI AAMI ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016 Biocompatibility 2-227 Complete ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
07/26/2016 Biocompatibility 2-228 Partial ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ANSI AAMI ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
07/26/2016 Biocompatibility 2-237 Partial ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016 Biocompatibility 2-240 Partial ANSI AAMI ISO TIR 10993-20:2006 Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO TS 10993-20 First edition 2006-08-01 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
07/26/2016 Biocompatibility 2-243 Partial ISO TR 10993-33 First Edition 2015-03-01 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
12/23/2016 Biocompatibility 2-244 Partial ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/23/2016 Biocompatibility 2-245 Complete ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
08/21/2017 Biocompatibility 2-246 Complete ASTM F1877-16 Standard Practice for Characterization of Particles
08/21/2017 Biocompatibility 2-247 Complete ISO 10993-6 Third edition 2016-12-01 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
08/21/2017 Biocompatibility 2-248 Complete ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
06/07/2018 Biocompatibility 2-249 Complete ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
06/07/2018 Biocompatibility 2-250 Complete ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
09/17/2018 Biocompatibility 2-255 Complete ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI AAMI ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
01/14/2019 Biocompatibility 2-258 Partial ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
 
 
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