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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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05/26/2025 Anesthesiology 1-193 Complete ISO 18190 Second edition 2025-02 Anaesthetic and respiratory equipment - General requirements for airways and related equipment
05/26/2025 Anesthesiology 1-194 Complete ISO 27427 Fourth edition 2023-07 Anaesthetic and respiratory equipment - Nebulizing systems and components
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
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
05/26/2025 Biocompatibility 2-305 Complete ASTM E1262-24 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
05/26/2025 Biocompatibility 2-306 Complete ASTM F1439-24 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
05/26/2025 Biocompatibility 2-307 Complete ASTM F1877-24 Standard Practice for Characterization of Particles
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
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
05/26/2025 Dental/
ENT
4-339 Complete ANSI ADA Standard No. 119-2023 Dentistry-Manual Toothbrushes
05/26/2025 Dental/
ENT
4-340 Complete ANSI ADA Standard No. 46-2016 Dental Patient Chair
05/26/2025 Dental/
ENT
4-341 Complete ANSI ADA Standard No. 47-1-2021 Stationary Dental Units and Patient Chairs-Part 1: General Requirements
05/26/2025 Dental/
ENT
4-342 Complete ANSI ADA Standard No. 47-2-2021 Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems
05/26/2025 Dental/
ENT
4-343 Complete ANSI ADA Standard No. 105-2024 Elastomeric Auxiliaries for Use in Orthodontics
05/26/2025 Dental/
ENT
4-344 Complete ANSI ADA Standard No. 186-2024 Dentistry - Polymer-based Machinable Blanks
05/26/2025 Dental/
ENT
4-345 Complete ANSI ADA Standard No. 187-2024 Dentistry - Dental CAD/CAM Machinable Ceramic Blanks
05/26/2025 Dental/
ENT
4-346 Complete ISO 9680 Fourth edition 2021-11 Dentistry - Operating lights
ANSI ADA Standard No. 89-2023 Dentistry - Dental Operating Lights
05/26/2025 Dental/
ENT
4-347 Complete ISO 22254 First edition 2005-08 Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection
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
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)]
05/26/2025 General II (ES/
EMC)
19-55 Complete IEC 62133-2 Edition 5.0 2021-09 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
05/26/2025 General II (ES/
EMC)
19-56 Complete IEC 60086-4 Edition 6.0 2025-01 Primary batteries - Part 4: Safety of lithium batteries
05/26/2025 General Plastic Surgery/
General Hospital
6-505 Complete ISO 21649 Second Edition 2023-01 Needle-free injectors for medical use -- Requirements and test methods
05/26/2025 General Plastic Surgery/
General Hospital
6-506 Complete ISO 8536-2 Fourth edition 2023-01 Infusion equipment for medical use - Part 2: Closures for infusion bottles
05/26/2025 General Plastic Surgery/
General Hospital
6-507 Complete ISO 23908 Second Edition 2024-12 Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods
05/26/2025 General Plastic Surgery/
General Hospital
6-508 Complete IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
05/26/2025 General Plastic Surgery/
General Hospital
6-509 Complete ASTM F3186-24 Standard Specification for Adult Portable Bed Rails and Related Products
05/26/2025 General Plastic Surgery/
General Hospital
6-510 Complete IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
05/26/2025 General Plastic Surgery/
General Hospital
6-511 Complete ISO 11040-4 Fourth edition 2024-06 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
05/26/2025 General Plastic Surgery/
General Hospital
6-512 Complete IEC 60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
05/26/2025 General Plastic Surgery/
General Hospital
6-513 Partial ISO 14607 Fourth edition 2024-12 Non-active surgical implants - Mammary implants - Specific requirements
05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing
05/26/2025 InVitro Diagnostics 7-329 Complete CLSI EP06-EG 2nd Edition Developer Validation of Linearity, Establishment Guide
05/26/2025 InVitro Diagnostics 7-330 Partial CLSI M38M51S 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
05/26/2025 InVitro Diagnostics 7-331 Complete CLSI AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition
05/26/2025 InVitro Diagnostics 7-332 Complete CLSI AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
05/26/2025 InVitro Diagnostics 7-333 Complete CLSI AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
05/26/2025 InVitro Diagnostics 7-334 Complete CLSI AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
05/26/2025 InVitro Diagnostics 7-335 Complete CLSI POCT01-A2 Point-of-Care Connectivity - Second Edition
05/26/2025 InVitro Diagnostics 7-336 Complete CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition.
05/26/2025 InVitro Diagnostics 7-337 Complete CLSI AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline
05/26/2025 InVitro Diagnostics 7-338 Complete CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
05/26/2025 InVitro Diagnostics 7-339 Complete CLSI AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
05/26/2025 InVitro Diagnostics 7-340 Complete CLSI LIS01-A2 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems - Second Edition.
05/26/2025 InVitro Diagnostics 7-341 Complete CLSI AUTO03-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition
05/26/2025 InVitro Diagnostics 7-342 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
05/26/2025 InVitro Diagnostics 7-343 Complete CLSI AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
05/26/2025 InVitro Diagnostics 7-344 Complete CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition.
05/26/2025 InVitro Diagnostics 7-345 Complete CLSI AUTO13-A2 (Formerly GP19-A2) Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
05/26/2025 Neurology 17-20 Complete IEC 60601-2-40 Third edition 2024-12 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
05/26/2025 Neurology 17-21 Partial ASTM F647-22 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
05/26/2025 Neurology 17-22 Complete IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
05/26/2025 ObGyn/
Gastroenterology/
Urology
9-151 Complete ASTM F1828-22 Standard Specification for Ureteral Stents
05/26/2025 Ophthalmic 10-96 Partial ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
05/26/2025 Ophthalmic 10-137 Complete ISO 11979-2 Third edition 2024-10 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
05/26/2025 Ophthalmic 10-138 Partial ISO 16971-1 First edition 2024-11 Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye
05/26/2025 Orthopedic 11-420 Complete ASTM F2580-24 Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
05/26/2025 Orthopedic 11-421 Complete ASTM F2077-24 Standard Test Methods for Intervertebral Body Fusion Devices
05/26/2025 Orthopedic 11-422 Complete ASTM F1798-24 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
05/26/2025 Radiology 12-367 Complete ISO 13695 Second edition 2024-11 Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
05/26/2025 Radiology 12-368 Complete ISO 13696 Second edition 2022-06 Optics and photonics - Test methods for radiation scattered by optical components
05/26/2025 Radiology 12-369 Complete ISO 11146-1 Second edition 2021-07 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
05/26/2025 Radiology 12-370 Complete ISO 11146-2 Second edition 2021-07 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
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
05/26/2025 Radiology 12-372 Complete ISO 14880-3 Second edition 2024-11 Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
05/26/2025 Radiology 12-373 Complete ISO 14880-4 Second edition 2024-11 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
05/26/2025 Radiology 12-374 Complete ISO 24013 Second edition 2023-06 Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
05/26/2025 Radiology 12-375 Complete ANSI UL 122-2019 Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019]
05/26/2025 Radiology 12-376 Complete IEC 61689 Edition 4.0 2022-03 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
05/26/2025 Radiology 12-377 Complete IEC 62127-03 Edition 2.0 2022-12 Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
05/26/2025 Radiology 12-378 Complete ISO 12609-1 Second edition 2021-10 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
05/26/2025 Radiology 12-379 Complete IEC 62127-2 Edition 2.0 2025-01 Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
05/26/2025 Radiology 12-380 Complete IEC 60601-2-37 Edition 3.0 2024-07 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
05/26/2025 Radiology 12-381 Complete IEC 60601-2-68 Edition 2.0 2025-02 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
05/26/2025 Radiology 12-382 Complete NEMA NU 2-2024 Performance Measurements of Positron Emission Tomographs
05/26/2025 Radiology 12-383 Complete NEMA NU 1-2023 Performance Measurements of Gamma Cameras
05/26/2025 Software/
Informatics
13-140 Complete FIRST CVSS v4.0 Common Vulnerability Scoring System version 4.0
05/26/2025 Software/
Informatics
13-142 Complete FIRST CVSS v3.1 Common Vulnerability Scoring System version 3.1
05/26/2025 Software/
Informatics
13-143 Complete AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software
05/26/2025 Software/
Informatics
13-144 Complete ISO IEEE 11073-10425 Edition 3, 2024-09 Health informatics - Device interoperability Part 10425: Personal health device communication - Device specialization - Continuous Glucose Monitor (CGM)
IEEE Std 11073-10425-2023 Health informatics - Device Interoperability Part 10425: Personal Health Device Communication - Device Specialization - Continuous Glucose Monitor (CGM)
05/26/2025 Software/
Informatics
13-145 Complete IEEE Std 11073-10419:2023 Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump
05/26/2025 Software/
Informatics
13-146 Complete IEEE 11073-10103 Second edition 2023 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
05/26/2025 Software/
Informatics
13-147 Complete IEEE Std 11073-10406-2023 Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
05/26/2025 Software/
Informatics
13-148 Complete IEEE Std 11073-10417-2023 Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter
05/26/2025 Sterility 14-610 Complete ISO 11138-7 First edition 2019-03 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
05/26/2025 Sterility 14-611 Complete ISO 11137-1 Second edition 2025-04 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
12/23/2024 Anesthesiology 1-182 Complete ISO 5362 Fifth edition 2024-07 Anaesthetic and respiratory equipment - Anaesthetic reservoir bags
12/23/2024 Anesthesiology 1-183 Complete ASTM G175-24 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
12/23/2024 Anesthesiology 1-184 Complete ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)].
12/23/2024 Anesthesiology 1-185 Complete ISO 80601-2-79 Second edition 2024-08 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
12/23/2024 Anesthesiology 1-186 Complete ISO 80601-2-80 Second edition 2024-08 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
12/23/2024 Anesthesiology 1-187 Complete ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
12/23/2024 Anesthesiology 1-188 Complete ISO 80601-2-84 Second edition 2023-11 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
12/23/2024 Anesthesiology 1-189 Complete ISO 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary
12/23/2024 Anesthesiology 1-190 Complete ISO 9360-1 First edition 2000-03 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml
12/23/2024 Anesthesiology 1-191 Complete ISO 9360-2 First edition 2001-07 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
12/23/2024 Anesthesiology 1-192 Complete ISO 23371 First edition 2022-05 Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices
12/23/2024 Biocompatibility 2-304 Partial ASTM F2382-24 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
 
 
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