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U.S. Department of Health and Human Services

Recognized Consensus Standards
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08/21/2017 Ophthalmic 10-104 ANSI Z80.20-2016 (R2021) American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
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 InVitro Diagnostics 7-236 CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
01/14/2019 Sterility 14-396 ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
05/29/2023 Cardiovascular 3-188 ISO 81060-3 First edition 2022-12 Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
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
12/20/2021 General Plastic Surgery/
General Hospital		 6-474 ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-496 ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
08/21/2017 Software/
Informatics		 13-92 IEEE ISO 11073-10421 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
12/21/2020 General Plastic Surgery/
General Hospital		 6-448 ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
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
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
01/14/2019 Ophthalmic 10-108 ISO 18369-2 Third edition 2017-08 Ophthalmic optics - Contact lenses - Part 2: Tolerances
01/14/2019 Dental/
ENT		 4-257 ISO 17730 First edition 2014-11-01 Dentistry - Fluoride varnishes
07/15/2019 Ophthalmic 10-89 ANSI Z80.7-2013 (R2018) American National Standard for Ophthalmic Optics - Intraocular Lenses
04/04/2016 Anesthesiology 1-106 ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
07/06/2020 General Plastic Surgery/
General Hospital		 6-443 ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
06/27/2016 General I (QS/
RM)		 5-57 ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
07/15/2019 Dental/
ENT		 4-259 ANSI ADA Standard No. 127-2018 Dynamic Loading Test for Endosseous Dental Implants
ISO 14801 Third edition 2016-11-01 Dentistry - Implants - Dynamic loading test for endosseous dental implants
07/06/2020 General Plastic Surgery/
General Hospital		 6-442 ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital		 6-446 ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital		 6-445 ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
04/04/2016 General Plastic Surgery/
General Hospital		 6-359 ISO 8536-9 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016 General Plastic Surgery/
General Hospital		 6-361 ISO 8536-11 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
08/14/2015 Anesthesiology 1-103 ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment -- Breathing sets and connectors
12/23/2016 Materials 8-439 ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
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
08/14/2015 Neurology 17-4 ASTM F647-94 (Reapproved 2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
12/23/2016 Biocompatibility 2-244 ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
04/04/2016 InVitro Diagnostics 7-259 CLSI GP23-A2 (Replaces GP23-A) Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition
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
08/14/2015 Ophthalmic 10-96 ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
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
01/14/2019 InVitro Diagnostics 7-269 CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
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
01/14/2019 Materials 8-179 ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
09/17/2018 Materials 8-473 ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
09/17/2018 General II (ES/
EMC)		 19-19 IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
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
01/14/2019 Cardiovascular 3-52 ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
06/27/2016 General Plastic Surgery/
General Hospital		 6-364 ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
07/15/2019 InVitro Diagnostics 7-290 CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
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
08/14/2015 InVitro Diagnostics 7-255 CLSI MM09-A2 (Replaces MM09-A) Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
06/27/2016 Radiology 12-302 IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
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)]
08/21/2017 InVitro Diagnostics 7-272 CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
01/14/2019 Cardiovascular 3-159 ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
01/14/2019 Orthopedic 11-184 ISO 8827 First edition 1988-10-15 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-133 ANSI AAMI ISO 23500-1:2019 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
ISO 23500-1 First edition 2019-02 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
07/06/2020 InVitro Diagnostics 7-296 CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
01/30/2014 InVitro Diagnostics 7-210 CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
12/23/2016 InVitro Diagnostics 7-268 CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
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
09/17/2018 General Plastic Surgery/
General Hospital		 6-408 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
09/17/2018 General II (ES/
EMC)		 19-8 ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-143 ISO 20696 First edition 2018-06; Corrected 2019-12 Sterile urethral catheters for single use
04/04/2016 Tissue Engineering 15-44 ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
06/27/2016 Radiology 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
05/29/2023 Cardiovascular 3-185 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 InVitro Diagnostics 7-317 CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
06/27/2016 InVitro Diagnostics 7-264 CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
05/29/2023 Dental/
ENT		 4-306 ANSI ADA Standard No. 94-2021 Central Compressed Air Source Equipment
ISO 22052 First edition 2020-06 Dentistry - Compressed air source equipment
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
05/29/2023 Dental/
ENT		 4-305 ANSI ADA Standard No. 177-2020 Central Suction Source Equipment
ISO 10637 Second edition 2018-05 Dentistry - Central suction source equipment
12/20/2021 General II (ES/
EMC)		 19-43 IEC 61326-2-6 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
04/04/2016 General Plastic Surgery/
General Hospital		 6-358 ISO 8536-8 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
04/04/2016 General Plastic Surgery/
General Hospital		 6-360 ISO 8536-10 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
06/07/2018 Neurology 17-1 AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
06/27/2016 Cardiovascular 3-143 ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
04/04/2016 Materials 8-409 ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
01/27/2015 Nanotechnology 18-3 ISO TS 14101 First edition 2012-11-01 Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
01/30/2014 InVitro Diagnostics 7-220 CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
01/14/2019 Nanotechnology 18-2 ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
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
08/14/2015 Sterility 14-460 ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
12/19/2022 Biocompatibility 2-296 ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
08/06/2013 InVitro Diagnostics 7-234 CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
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.
01/27/2015 InVitro Diagnostics 7-250 CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
08/06/2013 InVitro Diagnostics 7-243 CLSI M51-A (Replaces M51-P) Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
08/14/2015 Software/
Informatics		 13-73 IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-118 ANSI AAMI ISO 8637-1:2017 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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
07/06/2020 Materials 8-525 ISO TS 17137 Second edition 2019-09 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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)
01/27/2015 Software/
Informatics		 13-71 RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
05/30/2022 Physical Medicine 16-166 ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
07/15/2019 InVitro Diagnostics 7-291 CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
12/19/2022 Radiology 12-348 IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
03/01/2021 General Plastic Surgery/
General Hospital		 6-460 ASTM F3502-21 Standard Specification for Barrier Face Coverings
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-140 ANSI AAMI ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ISO 8637-2 First Edition 2018-07 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
01/30/2014 ObGyn/
Gastroenterology/
Urology		 9-89 ANSI AAMI ISO Standard
ISO 8638 Third edition 2010-07-01 Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters
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)].
12/20/2021 General II (ES/
EMC)		 19-42 IEC 61326-1 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
12/19/2022 InVitro Diagnostics 7-314 CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
05/30/2022 Sterility 14-578 ISO 17664-1 First edition 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
08/06/2013 Software/
Informatics		 13-54 IEEE ISO 11073-10404 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
01/30/2014 Sterility 14-334 ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
 
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