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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
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.
06/07/2021 Cardiovascular 3-129 Partial ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires
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
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
06/27/2016 Cardiovascular 3-143 Partial ISO 12417 First edition 2015-10-01 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
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
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 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
01/14/2019 InVitro Diagnostics 7-269 Partial CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
07/06/2020 General Plastic Surgery/
General Hospital		 6-446 Partial ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
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
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
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 General Plastic Surgery/
General Hospital		 6-178 Partial ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical 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
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
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.
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 ObGyn/
Gastroenterology/
Urology		 9-143 Partial ISO 20696 First edition 2018-06; Corrected 2019-12 Sterile urethral catheters for single use
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
10/17/2014 ObGyn/
Gastroenterology/
Urology		 9-95 Partial CEN EN 1615:2000 Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
12/21/2020 General II (ES/
EMC)		 19-36 Partial IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
05/29/2023 InVitro Diagnostics 7-317 Partial CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
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
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]
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
12/23/2019 Cardiovascular 3-163 Partial ISO 18242 First edition 2016-09-01 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
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
06/07/2021 Ophthalmic 10-122 Partial ISO 10939 Third edition 2017-05 Ophthalmic instruments - Slit-lamp microscopes
01/14/2019 Orthopedic 11-348 Partial ISO 19227 First edition 2018-03 Implants for surgery - Cleanliness of orthopedic implants - General requirements
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
07/15/2019 Ophthalmic 10-116 Partial ANSI Z80.35-2018 (R2023) American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
12/20/2021 Biocompatibility 2-294 Partial USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
01/27/2015 InVitro Diagnostics 7-250 Partial CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
12/21/2020 General Plastic Surgery/
General Hospital		 6-449 Partial ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
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 Cardiovascular 3-52 Partial ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
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
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
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
01/14/2019 Sterility 14-396 Partial ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
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
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
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 Nanotechnology 18-2 Partial ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
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
05/30/2022 Sterility 14-572 Partial ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
 
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