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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
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
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
05/29/2024 InVitro Diagnostics 7-321 Partial CLSI MM24 1st Edition Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
08/21/2017 InVitro Diagnostics 7-272 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
01/30/2014 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
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
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
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
05/29/2024 Ophthalmic 10-135 Partial ISO 11979-7 Fifth edition 2024-01 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
04/04/2016 Materials 8-409 Partial ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
05/29/2024 Ophthalmic 10-134 Partial ISO 10943 Fourth edition 2023-01 Ophthalmic instruments - Indirect ophthalmoscopes
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
01/30/2014 InVitro Diagnostics 7-210 Partial CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
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)]
08/14/2015 Software/
Informatics		 13-73 Partial IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
01/27/2015 InVitro Diagnostics 7-250 Partial CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
06/07/2018 Neurology 17-1 Partial AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
08/14/2015 Ophthalmic 10-96 Partial ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
08/14/2015 Neurology 17-4 Partial ASTM F647-94 (Reapproved 2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
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
09/17/2018 Materials 8-473 Partial ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
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
09/17/2018 Ophthalmic 10-56 Partial ANSI Z80.12-2007 (R2022) American National Standard for Ophthalmics - Multifocal Intraocular Lenses
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
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
01/14/2019 Cardiovascular 3-159 Partial ISO 5910 First edition 2018-06 Cardiovascular implants and extracorporeal systems - Cardiac valve repair 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
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
05/29/2024 General II (ES/
EMC)		 19-50 Partial IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
09/17/2018 General II (ES/
EMC)		 19-19 Partial 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
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
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
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
06/07/2021 Dental/
ENT		 4-280 Partial ANSI ADA Standard No. 117-2018 Fluoride varnishes
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
06/27/2016 InVitro Diagnostics 7-264 Partial CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
06/07/2021 InVitro Diagnostics 7-292 Partial CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
12/18/2023 General Plastic Surgery/
General Hospital		 6-497 Partial ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
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
01/27/2015 Software/
Informatics		 13-71 Partial RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
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
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)].
12/20/2021 Biocompatibility 2-294 Partial USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
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
12/20/2021 General II (ES/
EMC)		 19-42 Partial IEC 61326-1 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
12/20/2021 Cardiovascular 3-174 Partial ISO 5840-1 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
07/06/2020 General Plastic Surgery/
General Hospital		 6-440 Partial ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves
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.
12/20/2021 General II (ES/
EMC)		 19-43 Partial 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
12/19/2022 InVitro Diagnostics 7-314 Partial CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
12/20/2021 Biocompatibility 2-295 Partial USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test)
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
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
09/21/2016 InVitro Diagnostics 7-265 Partial CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
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
06/27/2016 General I (QS/
RM)		 5-57 Partial ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
07/06/2020 General Plastic Surgery/
General Hospital		 6-446 Partial ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
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 10-74 Partial ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus cameras
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
12/19/2022 Ophthalmic 10-132 Partial ISO 10942 Third edition 2022-01 Ophthalmic instruments - Direct ophthalmoscopes
12/21/2020 General Plastic Surgery/
General Hospital		 6-449 Partial ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
06/07/2021 Ophthalmic 10-122 Partial ISO 10939 Third edition 2017-05 Ophthalmic instruments - Slit-lamp microscopes
12/21/2020 Orthopedic 11-330 Partial ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
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
05/30/2022 Sterility 14-572 Partial ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
07/15/2019 InVitro Diagnostics 7-290 Partial CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
12/21/2020 General Plastic Surgery/
General Hospital		 6-448 Partial ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
06/07/2021 Cardiovascular 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
06/07/2021 InVitro Diagnostics 7-262 Partial CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-133 Partial ISO 23500-1 First edition 2019-02 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
ANSI AAMI ISO 23500-1:2019 Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
06/07/2021 General Plastic Surgery/
General Hospital		 6-389 Partial IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ANSI AAMI IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
12/21/2020 General II (ES/
EMC)		 19-38 Partial IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
05/30/2022 Physical Medicine 16-166 Partial 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
12/21/2020 Tissue Engineering 15-64 Partial ISO 22442-1 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
07/06/2020 General Plastic Surgery/
General Hospital		 6-178 Partial ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
07/15/2019 Ophthalmic 10-116 Partial ANSI Z80.35-2018 (R2023) American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
12/21/2020 Materials 8-543 Partial ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
05/30/2022 Sterility 14-578 Partial 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
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
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 Ophthalmic 10-93 Partial ANSI Z80.27-2014 (R2019) American National Standard for Ophthalmics - Implantable Glaucoma Devices
07/15/2019 InVitro Diagnostics 7-289 Partial CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
06/07/2021 Software/
Informatics		 13-117 Partial IEEE Std 11073-40101-2020 Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment.
01/14/2019 Orthopedic 11-348 Partial ISO 19227 First edition 2018-03 Implants for surgery - Cleanliness of orthopedic implants - General requirements
07/15/2019 Nanotechnology 18-14 Partial ISO TR 11360 First edition 2010-07-15 Nanotechnologies - Methodology for the classification and categorization of nanomaterials
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
01/14/2019 Sterility 14-396 Partial ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
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
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
07/15/2019 Nanotechnology 18-13 Partial ISO TS 18827 First edition 2017-06 Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials
07/06/2020 General Plastic Surgery/
General Hospital		 6-443 Partial ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
06/07/2021 Dental/
ENT		 4-276 Partial ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
ANSI ADA Standard No. 35-2019 Dental Handpieces and Motors
12/23/2016 Biocompatibility 2-244 Partial ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
 
 
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