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U.S. Department of Health and Human Services

Recognized Consensus Standards

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12/23/2016 Anesthesiology 1-118 ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
01/14/2019 Anesthesiology 1-114 ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
03/31/2006 Anesthesiology 1-67 NFPA 99:2005 Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities
08/21/2017 Anesthesiology 1-124 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
01/14/2019 Anesthesiology 1-117 ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
01/14/2019 Anesthesiology 1-138 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
08/21/2017 Anesthesiology 1-127 ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
06/07/2018 Anesthesiology 1-135 ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
01/14/2019 Anesthesiology 1-120 ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
03/16/2012 Anesthesiology 1-62 ANSI AAMI ISO 5356-1:2004 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
03/16/2012 Anesthesiology 1-75 ANSI AAMI ISO 5362:2006 Anaesthetic Reservoir Bags
ISO 5362 Fourth edition 2006-06-01 Anaesthetic Reservoir Bags
06/07/2018 Anesthesiology 1-129 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 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)]
01/30/2014 Anesthesiology 1-81 CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
07/09/2014 Anesthesiology 1-99 ASTM G175-13 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
09/17/2018 Anesthesiology 1-140 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
08/14/2015 Anesthesiology 1-105 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
12/23/2016 Anesthesiology 1-119 ISO 14408 Third edition 2016-02-15 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
07/15/2019 Anesthesiology 1-144 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
07/15/2019 Anesthesiology 1-143 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
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)]
07/09/2014 Anesthesiology 1-100 CGA V-1:2013 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
03/16/2012 Anesthesiology 1-73 ANSI AAMI ISO 10651-4:2002 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators
ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
06/07/2018 Anesthesiology 1-132 ISO 10079-2 Third Edition 2014-05-01 Medical suction equipment - Part 2: Manually powered suction equipment
06/07/2021 Anesthesiology 1-151 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
07/09/2014 Anesthesiology 1-101 CGA C-9:2013 Standard Color Marking of Compressed Gas Containers for Medical Use
08/20/2012 Anesthesiology 1-87 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 CGA V-7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
06/07/2018 Anesthesiology 1-133 ISO 10079-3 Third Edition 2014-05-01 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
03/16/2012 Anesthesiology 1-72 ANSI AAMI ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
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
01/30/2014 Anesthesiology 1-78 ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human Occupancy
04/04/2016 Anesthesiology 1-115 ISO 80601-2-70 First Edition 2015-01-15 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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)]
06/07/2018 Anesthesiology 1-136 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
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
03/16/2012 Anesthesiology 1-79 ISO 26825 First edition 2008-08-15 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
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
08/21/2017 Anesthesiology 1-123 ISO 7376 Second edition 2009-08-15 Anaesthetic and respiratory equipment-Laryngoscopes for tracheal intubation
12/21/2020 Anesthesiology 1-150 ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract
07/15/2019 Anesthesiology 1-125 ISO 8836 Fourth edition 2014-10-15 Suction catheters for use in the respiratory tract
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
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
07/15/2019 Anesthesiology 1-116 ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
12/23/2019 Anesthesiology 1-145 ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
07/15/2019 Anesthesiology 1-122 ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment-Oropharyngeal airways
07/15/2019 Anesthesiology 1-126 ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
07/15/2019 Anesthesiology 1-142 ISO 10079-1 Third Edition 2015-11-01 Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)]
04/04/2016 Anesthesiology 1-106 ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
09/17/2018 Anesthesiology 1-139 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
06/07/2018 Anesthesiology 1-134 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 1-137 ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
08/14/2015 Anesthesiology 1-103 ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment -- Breathing sets and connectors
07/26/2016 Biocompatibility 2-237 ANSI AAMI ISO 10993-17:2002/(R)2012 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/06/2020 Biocompatibility 2-276 ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
07/26/2016 Biocompatibility 2-169 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
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
07/26/2016 Biocompatibility 2-228 ANSI AAMI ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
12/23/2016 Biocompatibility 2-244 ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
06/07/2021 Biocompatibility 2-290 ISO /TS 37137-1 First edition 2021-03 Biological evaluation of absorbable medical devices - Part 1: General requirements.
07/26/2016 Biocompatibility 2-170 ANSI AAMI ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
08/21/2017 Biocompatibility 2-246 ASTM F1877-16 Standard Practice for Characterization of Particles
12/21/2020 Biocompatibility 2-282 ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
07/15/2019 Biocompatibility 2-263 ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
07/26/2016 Biocompatibility 2-133 ASTM F1408-97 (Reapproved 2013) Standard Practice for Subcutaneous Screening Test for Implant Materials
12/21/2020 Biocompatibility 2-286 USP 43-NF38:2020 <88> Biological Reactivity Tests, In Vivo
07/26/2016 Biocompatibility 2-238 ANSI AAMI BE83:2006/(R)2011 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
07/26/2016 Biocompatibility 2-191 ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/21/2020 Biocompatibility 2-287 USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)
12/21/2020 Biocompatibility 2-288 ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
06/07/2021 Biocompatibility 2-291 ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
07/26/2016 Biocompatibility 2-167 ANSI AAMI ISO TIR 10993-19:2006 Biological evaluation of medical devices - Part 19: Physicochemical, morphological, and topographical characterization of materials
ISO /TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials
07/26/2016 Biocompatibility 2-168 ANSI AAMI ISO 10993-9:2009/(R)2014 Biological evaluation of medical devices - Part 9: Framework for identification and quantitication of potential degradation products
ISO 10993-9 Second edition 2009-12-15 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/26/2016 Biocompatibility 2-243 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
07/26/2016 Biocompatibility 2-241 ANSI AAMI ISO /TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO /TR 37137 First edition 2014-05-15 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
01/14/2019 Biocompatibility 2-258 ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
01/30/2014 Biocompatibility 2-205 ANSI AAMI ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
ISO 14155 Second edition 2011-02-01 Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
07/26/2016 Biocompatibility 2-240 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
07/15/2019 Biocompatibility 2-265 ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
07/15/2019 Biocompatibility 2-267 ASTM F2888-19 Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials.
07/26/2016 Biocompatibility 2-124 ASTM F750-87 (Reapproved 2012) Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
12/21/2020 Biocompatibility 2-284 USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
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
12/21/2020 Biocompatibility 2-283 ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
07/26/2016 Biocompatibility 2-122 ASTM F719-81 (Reapproved 2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
07/06/2020 Biocompatibility 2-275 ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
12/21/2020 Biocompatibility 2-278 ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
12/21/2020 Biocompatibility 2-279 ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
08/21/2017 Biocompatibility 2-248 ANSI AAMI ISO 10993-4: 2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
01/30/2014 Biocompatibility 14-408 ANSI AAMI ISO 10993-7:2008(R)2012 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
12/21/2020 Biocompatibility 2-277 ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
12/23/2016 Biocompatibility 2-245 ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
06/07/2018 Biocompatibility 2-249 ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
12/23/2016 Biocompatibility 2-189 ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/21/2020 Biocompatibility 2-281 ISO /TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
07/26/2016 Biocompatibility 2-214 ASTM F619-14 Standard Practice for Extraction of Medical Plastics
12/21/2020 Biocompatibility 2-285 USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro - Elution Test
07/26/2016 Biocompatibility 2-119 ASTM F813-07 (Reapproved 2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
07/06/2020 Biocompatibility 2-273 ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/06/2020 Biocompatibility 2-274 ASTM F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/26/2016 Biocompatibility 2-197 ASTM F749-13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
 
 
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