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U.S. Department of Health and Human Services

Recognized Consensus Standards
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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
12/21/2020 Biocompatibility 2-280 ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
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
12/21/2020 Biocompatibility 2-282 ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
12/21/2020 Biocompatibility 2-283 ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
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
12/19/2022 Biocompatibility 2-289 ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
06/07/2021 Biocompatibility 2-290 ISO /TS 37137-1 First edition 2021-03 Biological evaluation of absorbable medical devices - Part 1: General requirements.
06/07/2021 Biocompatibility 2-291 ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
12/20/2021 Biocompatibility 2-292 USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/20/2021 Biocompatibility 2-293 USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Elution Test
12/20/2021 Biocompatibility 2-294 USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
12/20/2021 Biocompatibility 2-295 USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
12/19/2022 Biocompatibility 2-296 ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
12/19/2022 Biocompatibility 2-297 ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
12/19/2022 Biocompatibility 2-298 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)].
01/14/2019 Cardiovascular 3-44 ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
01/14/2019 Cardiovascular 3-52 ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
01/30/2014 Cardiovascular 3-54 ANSI AAMI ISO 7198:2016 Second edition Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
01/30/2014 Cardiovascular 3-63 ISO 11318:2002 Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
01/14/2019 Cardiovascular 3-66 ASTM F2081-06 (Reapproved 2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
01/14/2019 Cardiovascular 3-79 ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
01/14/2019 Cardiovascular 3-86 ASTM F2394-07 (Reapproved 2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
08/06/2013 Cardiovascular 3-87 ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability
01/25/2013 Cardiovascular 3-89 ANSI AAMI ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
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
03/16/2012 Cardiovascular 3-96 ANSI AAMI ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
08/20/2012 Cardiovascular 3-102 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
08/20/2012 Cardiovascular 3-103 ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012 Cardiovascular 3-104 ASTM F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
01/25/2013 Cardiovascular 3-105 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
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
09/17/2018 Cardiovascular 3-110 AAMI TIR 41:2011/(R)2017 Technical Information Report 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
08/06/2013 Cardiovascular 3-115 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
08/06/2013 Cardiovascular 3-116 ANSI AAMI ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 25539-2 Second edition 2012-12-01 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
01/30/2014 Cardiovascular 3-118 ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
07/06/2020 Cardiovascular 3-123 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
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
04/04/2016 Cardiovascular 3-125 ANSI AAMI ISO 5841-3:2013 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 5841-3 Third edition 2013-04-15 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
01/14/2019 Cardiovascular 3-126 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
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)]
06/07/2021 Cardiovascular 3-129 ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
06/15/2016 Cardiovascular 3-132 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
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
07/15/2019 Cardiovascular 3-137 ASTM F3036-13 Standard Guide for Testing Absorbable Stents
01/14/2019 Cardiovascular 3-138 ASTM F2942-13 Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
06/27/2016 Cardiovascular 3-143 ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
12/23/2016 Cardiovascular 3-144 ISO 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
08/21/2017 Cardiovascular 3-149 ISO 25539-1 Second edition 2017-02 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
06/07/2018 Cardiovascular 3-150 ANSI AAMI ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
09/17/2018 Cardiovascular 3-153 ASTM F2743-11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
09/17/2018 Cardiovascular 3-154 ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
07/06/2020 Cardiovascular 3-155 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
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
09/17/2018 Cardiovascular 3-156 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
01/14/2019 Cardiovascular 3-157 ANSI AAMI ISO 25539-1: 2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
01/14/2019 Cardiovascular 3-158 ASTM F3320-18 Standard Guide forCoating Characterization of Drug Coated Balloons
01/14/2019 Cardiovascular 3-159 ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
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.
07/06/2020 Cardiovascular 3-164 ASTM F1830-19 Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
07/06/2020 Cardiovascular 3-165 ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
06/07/2021 Cardiovascular 3-166 ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
07/06/2020 Cardiovascular 3-167 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
06/07/2021 Cardiovascular 3-168 IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
12/21/2020 Cardiovascular 3-169 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
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
06/07/2021 Cardiovascular 3-170 ISO 14708-5 Second edition 2020-05 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
12/20/2021 Cardiovascular 3-171 ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
12/20/2021 Cardiovascular 3-172 AAMI TIR42:2021 Evaluation of Particulates Associated with Vascular Medical Devices
12/20/2021 Cardiovascular 3-173 ISO 5840-3 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
12/20/2021 Cardiovascular 3-174 ISO 5840-1 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
12/20/2021 Cardiovascular 3-175 ISO 5840-2 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
12/20/2021 Cardiovascular 3-176 ISO 18193 First edition 2021-08 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
12/20/2021 Cardiovascular 3-177 ASTM F2606 - 08 (Reapproved 2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/20/2021 Cardiovascular 3-178 ASTM F3067 - 14 (Reapproved 2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/20/2021 Cardiovascular 3-179 ASTM F3172 - 15 (Reapproved 2021) Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
12/20/2021 Cardiovascular 3-180 ASTM F3505 - 21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
05/30/2022 Cardiovascular 3-181 ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
05/30/2022 Cardiovascular 3-182 ASTM F3036-21 Standard Guide for Testing Absorbable Stents
12/19/2022 Cardiovascular 3-183 ANSI AAMI ISO 11658: 2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 11658 First edition 2012-05-15 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
06/27/2016 Dental/
ENT		 4-86 ANSI ADA Standard No. 38-2000 (R2015) Metal-Ceramic Dental Restorative Systems
08/06/2013 Dental/
ENT		 4-90 ANSI ASA S3.39:1987 (Reaffirmed 2020) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
07/09/2014 Dental/
ENT		 4-97 ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
08/14/2015 Dental/
ENT		 4-130 ANSI ADA Standard No. 17-1983 (R2014) Denture Base Temporary Relining Resins
01/27/2015 Dental/
ENT		 4-136 ASTM F2504-05 (Reapproved 2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
01/30/2014 Dental/
ENT		 4-137 ANSI ADA Standard No. 78-2013 Dental obturating cones
ISO 6877 Second edition 2006-04-01 Dentistry - Root-canal obturating points
06/27/2016 Dental/
ENT		 4-139 ANSI ADA Standard No. 48-2004 (R2015) Visible Light Curing Units
09/09/2008 Dental/
ENT		 4-145 ISO 22803 First edition 2004-09-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
07/09/2014 Dental/
ENT		 4-149 ANSI ADA Standard No. 39-2006 (R2011) Pit and Fissure Sealants
01/30/2014 Dental/
ENT		 4-151 ANSI ADA Standard No. 15-2008 (R2013) Artificial Teeth for Dental Prostheses
ISO 22112 First edition 2005-11-01 Dentistry - Artificial teeth for dental prostheses
01/30/2014 Dental/
ENT		 4-153 ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
07/09/2014 Dental/
ENT		 4-160 ANSI ASA S3.1-1999 (Reaffirmed 2018) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
01/14/2019 Dental/
ENT		 4-162 ANSI ASA S3.4-2007 (Reaffirmed 2017) American National Standard Procedure for the Computation of Loudness of Steady Sounds
01/14/2019 Dental/
ENT		 4-163 ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
07/09/2014 Dental/
ENT		 4-165 ANSI ASA S3.13-1987 (Reaffirmed 2020) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
08/06/2013 Dental/
ENT		 4-167 ANSI ASA S3.21-2004 (Reaffirmed 2019) American National Standard Methods for Manual Pure-Tone Threshold Audiometry
01/14/2019 Dental/
ENT		 4-171 ANSI ASA S3.37-1987 (Reaffirmed 2020) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
03/16/2012 Dental/
ENT		 4-173 ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
07/09/2014 Dental/
ENT		 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2020) American National Standard For Rating Noise with Respect to Speech Interference
01/30/2014 Dental/
ENT		 4-180 ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
01/30/2014 Dental/
ENT		 4-181 ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
08/14/2015 Dental/
ENT		 4-184 ANSI ASA S3.25-2009 (Reaffirmed 2019) American National Standard For an Occluded Ear Simulator
01/27/2015 Dental/
ENT		 4-185 ANSI ASA S3.45-2009 (Reaffirmed 2019) American National Standard Procedures for Testing Basic Vestibular Function
01/30/2014 Dental/
ENT		 4-188 ISO 9917-2 Second edition 2010-04-15 Dentistry - Water-based cements - Part 2: Resin-modified cements
04/04/2016 Dental/
ENT		 4-190 ANSI ASA S3.35-2010 (Reaffirmed 2020) American National Standard Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
 
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