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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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12/21/2020 Dental/
ENT		 4-271 Complete ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
12/23/2024 Sterility 14-609 Complete AAMI TIR17:2024 Compatibility of materials subjected to sterilization
12/23/2019 Physical Medicine 16-213 Complete RESNA ANSI WC-1:2019 Section 7 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions
12/23/2019 Physical Medicine 16-214 Complete RESNA ANSI WC-1:2019 Section 8 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths
07/06/2020 Radiology 12-331 Complete NEMA Standards Publication MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
07/15/2019 Orthopedic 11-358 Complete ISO 14242-4 First edition 2018-05 Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
12/23/2024 InVitro Diagnostics 7-322 Complete CLSI M47 2nd Edition Principles and Procedures for Blood Cultures
03/18/2009 InVitro Diagnostics 7-189 Complete CLSI M47-A (Replaces M47-P) Principles and Procedures for Blood Cultures; Approved Guideline
07/15/2019 Radiology 12-326 Complete NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs
05/26/2025 Radiology 12-383 Complete NEMA NU 1-2023 Performance Measurements of Gamma Cameras
06/07/2021 Radiology 12-337 Complete NEMA NU 1-2018 Performance Measurements of Gamma Cameras
07/06/2020 General I (QS/
RM)		 5-130 Complete ISO 7010 Third edition 2019-07 Graphical symbols - Safety colours and safety signs - Registered safety signs
07/06/2020 Radiology 12-333 Complete IEC TR 63183 Edition 1.0 2019-12 Guidance on error and warning messages for software used in radiotherapy
06/07/2021 Dental/
ENT		 4-278 Complete ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
ANSI ADA Standard No. 19-2022 Elastomeric Impression and Bite Registration
07/28/2025 General II (ES/
EMC)		 19-57 Complete IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
05/26/2025 General I (QS/
RM)		 5-144 Complete ISO 80369-20 Second edition 2024-11 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
12/21/2020 Neurology 17-17 Complete ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
06/07/2021 Materials 8-562 Complete ISO ASTM 52904 First edition 2019-08 Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications
08/14/2015 General I (QS/
RM)		 5-97 Complete ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ANSI AAMI ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
05/26/2025 General I (QS/
RM)		 5-145 Complete IEC 60417:2025 DB Graphical symbols for use on equipment
05/26/2025 General II (ES/
EMC)		 19-54 Complete IEC 60086-5 Edition 5.0 2021-09 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)]
08/21/2017 General II (ES/
EMC)		 19-24 Complete IEC 60086-5 Edition 4.0 2016-07 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
05/26/2025 General II (ES/
EMC)		 19-55 Complete IEC 62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/23/2019 General II (ES/
EMC)		 19-33 Complete IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
01/15/2013 InVitro Diagnostics 7-235 Complete CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
07/15/2019 Sterility 14-530 Complete ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
06/07/2021 General II (ES/
EMC)		 19-40 Complete IEC 60086-4 Edition 5.0 2019-04 Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
05/26/2025 Dental/
ENT		 4-339 Complete ANSI ADA Standard No. 119-2023 Dentistry-Manual Toothbrushes
05/26/2025 Anesthesiology 1-194 Complete ISO 27427 Fourth edition 2023-07 Anaesthetic and respiratory equipment - Nebulizing systems and components
08/06/2013 Software/
Informatics		 13-55 Complete IEEE Std 11073-10421-2010 Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/21/2017 Software/
Informatics		 13-67 Complete ISO IEEE 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
IEEE Std 11073-10418-2011 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor
12/23/2019 Materials 8-501 Complete ISO 5834-1 Fourth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
12/21/2020 Anesthesiology 1-149 Complete ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
05/26/2025 Anesthesiology 1-195 Complete ISO 80369-2 First edition 2024-09 Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
08/20/2012 Cardiovascular 3-103 Complete ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
12/20/2021 Physical Medicine 16-232 Complete IEC 80601-2-78 Edition 1.0 2019-07 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
05/29/2023 Materials 8-598 Complete ASTM F3109-22 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/21/2020 Anesthesiology 1-150 Complete ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract
06/07/2021 Ophthalmic 10-124 Complete ISO 11979-1 Fourth edition 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
07/06/2020 General Plastic Surgery/
General Hospital		 6-444 Complete ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves
01/14/2019 Dental/
ENT		 4-256 Complete ANSI ADA Standard No. 132-2015 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
04/04/2016 Materials 8-200 Complete ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
12/23/2019 Anesthesiology 1-145 Complete ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
12/21/2020 General I (QS/
RM)		 5-131 Complete IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
12/21/2020 General I (QS/
RM)		 5-132 Complete IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020 Tissue Engineering 15-65 Complete ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
12/21/2020 Sterility 14-553 Complete ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
12/20/2021 Materials 8-572 Complete ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
07/06/2020 Biocompatibility 2-275 Complete ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
05/30/2022 Materials 8-589 Complete ASTM F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
12/21/2020 Materials 8-548 Complete ISO ASTM 52915 Third edition 2020-03 Specification for additive manufacturing file format (AMF) Version 1.2
06/07/2021 Dental/
ENT		 4-273 Complete ANSI ASA S3.7-2016 (Reaffirmed 2025) American National Standard Method for Coupler Calibration of Earphones
06/07/2021 Dental/
ENT		 4-275 Complete ANSI ASA S3.6-2018 (Reaffirmed 2023) American National Standard Specification for Audiometers
01/14/2019 Cardiovascular 3-44 Complete ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
12/19/2022 General Plastic Surgery/
General Hospital		 6-484 Complete ASTM F3502-22a Standard Specification for Barrier Face Coverings
05/30/2022 Cardiovascular 3-182 Complete ASTM F3036-21 Standard Guide for Testing Absorbable Stents
12/21/2020 General II (ES/
EMC)		 19-37 Complete IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
12/21/2020 Materials 8-550 Complete ASTM F2181-20 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
12/21/2020 Materials 8-551 Complete ASTM F2895-20 Standard Practice for Digital Radiography of Cast Metallic Implants
12/21/2020 Materials 8-553 Complete ISO ASTM 52903-1 First edition 2020-04 Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials
07/15/2019 Materials 8-495 Complete ISO 5834-3 Second edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
06/07/2021 Dental/
ENT		 4-279 Complete ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT		 4-283 Complete ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
ANSI ADA Standard No. 125-2018 Manual Interdental Brushes
12/21/2020 Orthopedic 11-371 Complete ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
05/30/2022 Sterility 14-577 Complete ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
09/21/2016 General Plastic Surgery/
General Hospital		 6-381 Complete ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
12/20/2021 Ophthalmic 10-129 Complete ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
12/20/2021 Ophthalmic 10-130 Complete ANSI Z80.36-2021 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
12/20/2021 Dental/
ENT		 4-284 Complete ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
09/17/2018 Materials 8-467 Complete ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
12/18/2023 Orthopedic 11-409 Complete ASTM F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
06/07/2021 Materials 8-558 Complete ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
07/15/2019 Orthopedic 11-354 Complete ASTM F3295-18 Standard Guide for Impingement Testing of Total Disc Prostheses
12/21/2020 Orthopedic 11-374 Complete ISO 7207-2 Second edition 2011-07-01 Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
12/23/2019 Materials 8-491 Complete ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
05/26/2025 Anesthesiology 1-196 Complete ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
12/21/2020 Materials 8-545 Complete ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
12/21/2020 InVitro Diagnostics 7-302 Complete CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
12/21/2020 InVitro Diagnostics 7-305 Complete ISO 17511 Second edition 2020-04 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
05/26/2025 Cardiovascular 3-198 Complete ISO 25539-3 Second edition 2024-10 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
05/26/2025 Cardiovascular 3-199 Complete ASTM F1841-25 Standard Practice for Assessment of Hemolysis in Blood Pumps
12/21/2020 Materials 8-546 Complete ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
12/21/2020 Materials 8-547 Complete ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
07/06/2020 General I (QS/
RM)		 5-126 Complete ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
09/17/2018 Anesthesiology 1-140 Complete ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
07/06/2020 Cardiovascular 3-165 Complete ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
05/26/2025 Radiology 12-371 Complete ISO 14880-2 Second edition 2024-11 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
12/19/2007 Radiology 12-171 Complete ISO 14880-2:2006 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
06/07/2021 Dental/
ENT		 4-274 Complete ANSI ASA S3.2-2020 American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
06/07/2021 Dental/
ENT		 4-277 Complete ANSI IEEE C63.19-2019 American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
07/15/2019 Orthopedic 11-356 Complete ISO 15142-2 First edition 2003-08-01 Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
06/07/2021 Materials 8-560 Complete ASTM D1415-18 Standard Test Method for Rubber Property - International Hardness
07/15/2019 Anesthesiology 1-143 Complete ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-136 Complete ISO 23500-4 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
ANSI AAMI ISO 23500-4:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
07/15/2019 Biocompatibility 2-267 Complete ASTM F2888-19 Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials.
05/26/2025 Cardiovascular 3-200 Complete ASTM F2477-24 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
 
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