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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2021 Ophthalmic 10-123 Partial ISO 15004-1 Second edition 2020-5 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
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 InVitro Diagnostics 7-236 Partial CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
01/14/2019 Orthopedic 11-348 Partial ISO 19227 First edition 2018-03 Implants for surgery - Cleanliness of orthopedic implants - 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
07/15/2019 InVitro Diagnostics 7-290 Partial CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
01/14/2019 Ophthalmic 10-108 Partial ISO 18369-2 Third edition 2017-08 Ophthalmic optics - Contact lenses - Part 2: Tolerances
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
01/30/2014 InVitro Diagnostics 7-220 Partial CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
01/14/2019 Ophthalmic 10-93 Partial ANSI Z80.27-2014 (R2019) American National Standard for Ophthalmics - Implantable Glaucoma Devices
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
07/06/2020 General Plastic Surgery/
General Hospital		 6-443 Partial ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
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 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
07/15/2019 InVitro Diagnostics 7-289 Partial CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
01/30/2014 InVitro Diagnostics 7-210 Partial CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
12/21/2020 Materials 8-543 Partial ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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
01/14/2019 Ophthalmic 10-74 Partial ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus cameras
06/07/2021 Cardiovascular 3-166 Partial ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
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
01/14/2019 Ophthalmic 10-85 Partial ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
01/14/2019 Ophthalmic 10-86 Partial ISO 14729 First edition 2001-04-15 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010]
01/14/2019 Cardiovascular 3-159 Partial ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
06/07/2021 Cardiovascular 3-168 Partial IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
06/27/2016 General I (QS/
RM)		 5-57 Partial ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
08/21/2017 Ophthalmic 10-104 Partial ANSI Z80.20-2016 (R2021) American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
01/14/2019 Sterility 14-396 Partial ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
04/04/2016 Anesthesiology 1-106 Partial ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
01/14/2019 Nanotechnology 18-2 Partial ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
12/19/2022 ObGyn/
Gastroenterology/
Urology		 9-140 Partial ISO 8637-2 First Edition 2018-07 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
ANSI AAMI ISO 8637-2:2018 Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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
01/14/2019 Orthopedic 11-184 Partial ISO 8827 First edition 1988-10-15 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
04/04/2016 InVitro Diagnostics 7-259 Partial CLSI GP23-A2 (Replaces GP23-A) Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition
07/15/2019 Ophthalmic 10-89 Partial ANSI Z80.7-2013 (R2023) American National Standard for Ophthalmic Optics - Intraocular Lenses
07/15/2019 Dental/
ENT		 4-259 Partial ISO 14801 Third edition 2016-11-01 Dentistry - Implants - Dynamic loading test for endosseous dental implants
ANSI ADA Standard No. 127-2018 Dynamic Loading Test for Endosseous Dental Implants
04/04/2016 Tissue Engineering 15-44 Partial ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
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
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
08/06/2013 InVitro Diagnostics 7-234 Partial CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
04/04/2016 Materials 8-409 Partial ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
12/23/2016 Biocompatibility 2-244 Partial ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
08/14/2015 Neurology 17-4 Partial ASTM F647-94 (Reapproved 2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
12/18/2023 Nanotechnology 18-24 Partial ASTM E2524-22 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
04/04/2016 General Plastic Surgery/
General Hospital		 6-359 Partial 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 Partial ISO 8536-11 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
08/06/2013 InVitro Diagnostics 7-243 Partial CLSI M51-A (Replaces M51-P) Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
05/29/2023 Dental/
ENT		 4-305 Partial ISO 10637 Second edition 2018-05 Dentistry - Central suction source equipment
ANSI ADA Standard No. 177-2020 Central Suction Source Equipment
05/29/2023 General Plastic Surgery/
General Hospital		 6-487 Partial ANSI AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
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
12/18/2023 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
09/17/2018 General Plastic Surgery/
General Hospital		 6-408 Partial ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
07/06/2020 General Plastic Surgery/
General Hospital		 6-178 Partial ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
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
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
05/29/2023 ObGyn/
Gastroenterology/
Urology		 9-143 Partial ISO 20696 First edition 2018-06; Corrected 2019-12 Sterile urethral catheters for single use
04/04/2016 General Plastic Surgery/
General Hospital		 6-358 Partial 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 Partial 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
09/17/2018 ObGyn/
Gastroenterology/
Urology		 9-118 Partial ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ANSI AAMI ISO 8637-1:2017 Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
12/23/2016 Materials 8-439 Partial ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
06/27/2016 Radiology 12-302 Partial 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
01/27/2015 InVitro Diagnostics 7-250 Partial CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
05/29/2023 InVitro Diagnostics 7-317 Partial CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
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
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
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
06/27/2016 Radiology 12-295 Partial 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
12/18/2023 Radiology 12-348 Partial 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
12/18/2023 Radiology 12-353 Partial ANSI Z136.1-2022 American National Standard for Safe Use of Lasers
08/14/2015 Anesthesiology 1-103 Partial ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment - Breathing sets and connectors
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
08/14/2015 Ophthalmic 10-96 Partial ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
01/14/2019 Materials 8-179 Partial ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
05/29/2023 Dental/
ENT		 4-306 Partial ISO 22052 First edition 2020-06 Dentistry - Compressed air source equipment
ANSI ADA Standard No. 94-2021 Central Compressed Air Source Equipment
08/21/2017 InVitro Diagnostics 7-272 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
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
06/27/2016 Cardiovascular 3-143 Partial ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
06/27/2016 General Plastic Surgery/
General Hospital		 6-364 Partial ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
06/27/2016 InVitro Diagnostics 7-264 Partial CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
07/06/2020 General Plastic Surgery/
General Hospital		 6-445 Partial ASTM D5250-19(2023) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
08/06/2013 Software/
Informatics		 13-54 Partial ISO IEEE 11073-10404 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
12/20/2021 General Plastic Surgery/
General Hospital		 6-474 Partial ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-496 Partial ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
01/14/2019 InVitro Diagnostics 7-269 Partial CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
01/14/2019 Cardiovascular 3-52 Partial ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
08/14/2015 Sterility 14-460 Partial ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ANSI AAMI ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
07/06/2020 Biocompatibility 2-276 Partial 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.
01/30/2014 Sterility 14-334 Partial ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
01/30/2014 Sterility 14-336 Partial ISO 14161 Second edition 2009-09-15 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ANSI AAMI ISO 14161-2009/(R)2014 Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
08/14/2015 InVitro Diagnostics 7-255 Partial CLSI MM09-A2 (Replaces MM09-A) Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
12/18/2023 Dental/
ENT		 4-319 Partial ISO 17730 Second edition 2020-09 Dentistry - Fluoride varnishes
ANSI ADA Standard No. 117-2022 Dentistry - Fluoride Varnishes
01/14/2019 Dental/
ENT		 4-257 Partial ISO 17730 First edition 2014-11-01 Dentistry - Fluoride varnishes
06/07/2021 Dental/
ENT		 4-280 Partial ANSI ADA Standard No. 117-2018 Fluoride varnishes
09/17/2018 Materials 8-473 Partial ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
01/27/2015 Nanotechnology 18-3 Partial ISO TS 14101 First edition 2012-11-01 Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
12/18/2023 General Plastic Surgery/
General Hospital		 6-497 Partial ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
07/26/2016 Biocompatibility 2-191 Partial ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/06/2020 General Plastic Surgery/
General Hospital		 6-442 Partial ASTM D6977-19(2023) Standard Specification for Polychloroprene Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital		 6-446 Partial ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
 
 
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