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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/20/2021 Cardiovascular 3-177 Complete ASTM F2606-08 (Reapproved 2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/23/2024 Cardiovascular 3-193 Complete ISO 12417-1 Second edition 2024-02 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
06/27/2016 Cardiovascular 3-143 Complete ISO 12417-1 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
05/30/2022 Cardiovascular 3-181 Complete ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/18/2023 Cardiovascular 3-189 Complete ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
12/18/2023 Cardiovascular 3-190 Complete ISO PAS 7020 First edition 2023-05 Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
01/14/2019 Cardiovascular 3-158 Complete ASTM F3320-18 Standard Guide forCoating Characterization of Drug Coated Balloons
01/25/2013 Cardiovascular 3-89 Complete ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ANSI AAMI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
06/15/2016 Cardiovascular 3-132 Complete ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
ANSI AAMI ISO 27185:2012 Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
08/20/2012 Cardiovascular 3-104 Complete ASTM F2914-12 (Reapproved 2018) Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
05/29/2024 Cardiovascular 3-191 Complete ISO 18242 First edition 2016-09-01 [Including AMD1:2023] Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)]
06/07/2021 Cardiovascular 3-170 Complete ISO 14708-5 Second edition 2020-05 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
01/14/2019 Cardiovascular 3-66 Complete ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
05/29/2024 Cardiovascular 3-192 Complete ISO 22679 First edition 2021-11 Cardiovascular implants - Transcatheter cardiac occluders
07/06/2020 Cardiovascular 3-164 Complete ASTM F1830-19 (Reapproved 2024) Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps
01/14/2019 Cardiovascular 3-44 Complete ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
01/30/2014 Cardiovascular 3-118 Complete ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
12/22/2025 Cardiovascular 3-202 Complete IEC 60601-2-34 Edition 4.0 2024-10 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
08/20/2012 Cardiovascular 3-102 Complete IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
08/06/2013 Cardiovascular 3-115 Complete IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
12/23/2024 Cardiovascular 3-194 Complete ISO 7199 Fourth edition 2024-09 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
06/07/2018 Cardiovascular 3-150 Complete ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
ANSI AAMI ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
07/06/2020 Cardiovascular 3-155 Complete IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
08/21/2017 Cardiovascular 3-149 Complete ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
ANSI AAMI ISO 25539-1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
12/20/2021 Cardiovascular 3-178 Complete ASTM F3067-14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/20/2021 Cardiovascular 3-171 Complete ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
07/06/2020 Cardiovascular 3-167 Complete ISO TS 81060-5 First edition 2020-02 Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
12/23/2019 Cardiovascular 3-162 Complete ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
09/17/2018 Cardiovascular 3-110 Complete AAMI TIR41:2011/(R)2025 Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
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
12/20/2021 Cardiovascular 3-172 Complete AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
09/17/2018 Cardiovascular 3-156 Complete ISO 14708-1 Second edition 2014-08-15 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ANSI AAMI ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
09/17/2018 Cardiovascular 3-154 Complete ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
12/23/2016 Cardiovascular 3-144 Complete ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
ANSI AAMI ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
12/20/2021 Cardiovascular 3-179 Complete ASTM F3172-15 (Reapproved 2021) Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
12/20/2021 Cardiovascular 3-176 Complete ISO 18193 First edition 2021-08 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
09/17/2018 Cardiovascular 3-153 Complete ASTM F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
01/14/2019 Cardiovascular 3-52 Partial ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
12/22/2025 Cardiovascular 3-203 Partial IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
12/23/2019 Cardiovascular 3-163 Partial ISO 18242 First edition 2016-09-01 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
06/07/2021 Cardiovascular 3-168 Partial IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
01/14/2019 Cardiovascular 3-86 Partial ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
07/06/2020 Cardiovascular 3-123 Partial IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
ANSI AAMI IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
12/18/2023 Cardiovascular 3-126 Partial IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
05/29/2023 Cardiovascular 3-185 Partial ANSI AAMI PC76:2021 Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
05/29/2023 Cardiovascular 3-188 Partial ISO 81060-3 First edition 2022-12 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
12/20/2021 Cardiovascular 3-174 Partial ISO 5840-1 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
12/22/2025 Cardiovascular 3-201 Complete IEC 60601-2-31 Edition 3.0 2020-01 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
06/07/2021 Cardiovascular 3-166 Partial ISO 81060-2 Third edition 2018-11 [Including AMD1:2020] Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
12/23/2024 Cardiovascular 3-196 Partial ISO 81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024] Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)]
06/07/2021 Cardiovascular 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
12/21/2020 Cardiovascular 3-169 Partial IEC 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
ANSI AAMI IEC 60601-2-4:2010/A1:2018 (Consolidated Text) Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
12/23/2024 Cardiovascular 3-195 Partial ISO 5910 Second edition 2024-07 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
01/14/2019 Cardiovascular 3-159 Partial ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
12/18/2023 Cardiovascular 3-105 Partial IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
ANSI AAMI IEC 60601-2-25:2011/(R)2016 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
06/07/2021 Biocompatibility 2-290 Partial ISO TS 37137-1 First edition 2021-03 Biological evaluation of absorbable medical devices - Part 1: General requirements.
06/07/2021 Biocompatibility 2-291 Partial ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
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
12/21/2020 Biocompatibility 2-288 Partial ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
12/23/2024 Biocompatibility 2-304 Partial ASTM F2382-24 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
12/23/2016 Biocompatibility 2-244 Partial ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/19/2022 Biocompatibility 2-296 Partial ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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
12/19/2022 Biocompatibility 2-298 Partial ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
05/29/2023 Biocompatibility 2-301 Complete ASTM F1983-23 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
12/20/2021 Biocompatibility 2-295 Partial USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
12/20/2021 Biocompatibility 2-294 Partial USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
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
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
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
12/18/2023 Biocompatibility 2-303 Partial ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
12/20/2021 Biocompatibility 2-292 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/20/2021 Biocompatibility 2-293 Complete USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Elution Test
12/21/2020 Biocompatibility 2-281 Complete ISO TS 10993-19 Second edition 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
12/21/2020 Biocompatibility 2-277 Complete ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
07/06/2020 Biocompatibility 2-274 Complete ASTM F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/15/2019 Biocompatibility 2-264 Complete ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
12/21/2020 Biocompatibility 2-280 Complete ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
05/29/2023 Biocompatibility 2-300 Complete ISO 10993-2 Third edition 2022-11 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/15/2019 Biocompatibility 2-268 Complete 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 2-279 Complete ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
07/15/2019 Biocompatibility 2-266 Complete ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
07/15/2019 Biocompatibility 2-267 Complete ASTM F2888-19 Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials.
07/06/2020 Biocompatibility 2-273 Complete ISO 10993-9 Third edition 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/15/2019 Biocompatibility 2-265 Complete ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
08/21/2017 Biocompatibility 2-246 Complete ASTM F1877-16 Standard Practice for Characterization of Particles
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
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
12/21/2020 Biocompatibility 2-282 Complete ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
07/15/2019 Biocompatibility 2-263 Complete ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
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
05/26/2025 Biocompatibility 2-307 Complete ASTM F1877-24 Standard Practice for Characterization of Particles
06/07/2018 Biocompatibility 2-250 Complete ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
05/26/2025 Biocompatibility 2-306 Complete ASTM F1439-24 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant 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
05/26/2025 Biocompatibility 2-305 Complete ASTM E1262-24 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
12/18/2023 Biocompatibility 2-302 Complete ASTM F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
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
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
12/22/2025 Biocompatibility 2-308 Complete ASTM F1984-25 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
12/22/2025 Biocompatibility 2-309 Complete ASTM F895-25 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/22/2025 Biocompatibility 2-310 Complete ASTM F748-25 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/19/2022 Biocompatibility 2-289 Complete ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/26/2016 Biocompatibility 2-227 Complete ASTM F1983-14 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
07/26/2016 Biocompatibility 2-213 Complete ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
05/29/2023 Biocompatibility 2-299 Complete ASTM F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
12/21/2020 Biocompatibility 2-278 Complete ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
12/19/2022 Biocompatibility 2-297 Complete ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
12/21/2020 Biocompatibility 2-283 Complete ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
07/06/2020 Biocompatibility 2-275 Complete 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)]
12/22/2025 Biocompatibility 2-311 Complete ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
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
12/23/2016 Biocompatibility 2-189 Complete ASTM F895-11 (Reapproved 2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
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
12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
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
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
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
12/22/2025 Anesthesiology 1-201 Complete ISO 19223-2 First edition 2025-04 Lung ventilators and related equipment - Vocabulary and semantics - Part 2: High frequency and jet ventilation.
05/26/2025 Anesthesiology 1-194 Complete ISO 27427 Fourth edition 2023-07 Anaesthetic and respiratory equipment - Nebulizing systems and components
05/26/2025 Anesthesiology 1-195 Complete ISO 80369-2 First edition 2024-09 Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
12/23/2019 Anesthesiology 1-145 Complete ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
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
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
12/18/2023 Anesthesiology 1-162 Complete ISO 10651-4 Second edition 2023-03 Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
12/23/2024 Anesthesiology 1-188 Complete ISO 80601-2-84 Second edition 2023-11 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
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
12/19/2022 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 1-158 Complete ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements
12/18/2023 Anesthesiology 1-164 Complete ISO 5361 Fourth edition 2023-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
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
12/18/2023 Anesthesiology 1-166 Complete ISO 11195 Second edition 2018-01 Gas mixers for medical use - Stand-alone gas mixers
12/23/2016 Anesthesiology 1-118 Complete ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
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)]
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
12/21/2020 Anesthesiology 1-149 Complete ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
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
12/23/2024 Anesthesiology 1-189 Complete ISO 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary
12/22/2025 Anesthesiology 1-202 Complete ISO 19223-3 First edition 2025-09 Lung ventilators and related equipment - Vocabulary and semantics - Part 3: Respiratory care
12/22/2025 Anesthesiology 1-197 Complete ISO 17510 Second Edition 2025-11 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
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
12/19/2022 Anesthesiology 1-155 Complete ISO 10079-2 Fourth edition 2022-03 Medical suction equipment - Part 2: Manually powered suction equipment
12/22/2025 Anesthesiology 1-198 Complete ISO 7376 Third edition 2020-08 [Including AMD1:2025] Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements [Including Amendment 1 (2025)]
05/29/2024 Anesthesiology 1-171 Complete ISO 5367 Sixth edition 2023-07 Anaesthetic and respiratory equipment - Breathing sets and connectors
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
12/22/2025 Anesthesiology 1-200 Complete ISO 7376-2 First edition 2025-09 Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes
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
05/26/2025 Anesthesiology 1-193 Complete ISO 18190 Second edition 2025-02 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
12/19/2022 Anesthesiology 1-157 Complete ISO 10079-1 Fourth edition 2022-03 Medical suction equipment - Part 1: Electrically powered suction equipment
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
12/22/2025 Anesthesiology 1-199 Complete ISO 80601-2-70 Third edition 2025-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
05/26/2025 Anesthesiology 1-196 Complete ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
12/23/2024 Anesthesiology 1-187 Complete ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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 1-175 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
12/21/2020 Anesthesiology 1-150 Complete ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract
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
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
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
08/14/2015 Anesthesiology 1-103 Complete ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment - Breathing sets and connectors
10/07/2024 Anesthesiology 1-180 Complete NFPA 99:2024 Health Care Facilities Code
12/19/2022 Anesthesiology 1-153 Complete NFPA 99:2021 Health Care Facilities Code
05/29/2024 Anesthesiology 1-172 Complete ISO 11712 Second edition 2023-11 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
07/15/2019 Anesthesiology 1-126 Complete ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
12/23/2024 Anesthesiology 1-186 Complete ISO 80601-2-80 Second edition 2024-08 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
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
01/14/2019 Anesthesiology 1-114 Complete ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
12/23/2024 Anesthesiology 1-184 Complete ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)].
12/23/2024 Anesthesiology 1-190 Complete ISO 9360-1 First edition 2000-03 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
12/23/2024 Anesthesiology 1-191 Complete ISO 9360-2 First edition 2001-07 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
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
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
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
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
05/30/2022 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
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 1-167 Complete CGA V-5:2019 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
10/07/2024 Anesthesiology 1-181 Complete ASME PVHO-1-2023 Safety Standard for Pressure Vessels for Human Occupancy
12/19/2022 Anesthesiology 1-154 Complete ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy
12/23/2024 Anesthesiology 1-182 Complete ISO 5362 Fifth edition 2024-07 Anaesthetic and respiratory equipment - Anaesthetic reservoir bags
07/09/2014 Anesthesiology 1-100 Complete CGA V-1:2013 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
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 1-168 Complete CGA V-7.1:2021 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
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
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
01/14/2019 Anesthesiology 1-117 Complete ISO 5366 First edition 2016-10-01 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
12/23/2024 Anesthesiology 1-192 Complete ISO 23371 First edition 2022-05 Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices
07/15/2019 Anesthesiology 1-116 Complete ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
07/15/2019 Anesthesiology 1-122 Complete ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment-Oropharyngeal airways
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
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
05/29/2023 Anesthesiology 1-161 Complete ISO 16628 Second edition 2022-06 Anaesthetic and respiratory equipment - Tracheobronchial tubes
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)]
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
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
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)
01/30/2014 Anesthesiology 1-97 Complete CGA V-7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
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
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
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)]
05/29/2024 Anesthesiology 1-170 Complete CGA C-9:2019 Standard Color Marking of Compressed Gas Containers for Medical Use
07/09/2014 Anesthesiology 1-101 Complete CGA C-9:2013 Standard Color Marking of Compressed Gas Containers for Medical Use
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
12/23/2024 Anesthesiology 1-183 Complete ASTM G175-24 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
12/23/2024 Anesthesiology 1-185 Complete ISO 80601-2-79 Second edition 2024-08 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
04/04/2016 Anesthesiology 1-106 Partial ISO 17510 First Edition 2015-08-01 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
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
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
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
 
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