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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2021 Radiology 12-340 Complete IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
12/20/2021 Radiology 12-341 Complete IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
05/30/2022 Radiology 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
05/30/2022 Radiology 12-344 Complete IEC 62563-2 Edition 1.0 2021-11 Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
05/30/2022 Radiology 12-345 Complete IEC 61223-3-7 Edition 1.0 2021-12 Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
12/19/2022 Radiology 12-346 Complete ISO 12005 Third edition 2022-05 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
05/29/2023 Radiology 12-347 Complete IEC 60601-2-33 Edition 4.0 2022-08 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
05/29/2023 Radiology 12-350 Complete IEC 60806 Edition 2.0 2022-11 Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis
05/29/2023 Radiology 12-351 Complete IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12/18/2023 Radiology 12-353 Partial ANSI Z136.1-2022 American National Standard for Safe Use of Lasers
05/29/2024 Radiology 12-354 Complete NEMA MS 4-2023 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
05/29/2024 Radiology 12-355 Complete IEC 60601-2-57 Edition 2.0 2023-07 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
05/29/2024 Radiology 12-356 Complete IEC 60601-2-22 Edition 4.0 2019-11 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
05/29/2024 Radiology 12-357 Complete IEC 63145-20-10 Edition 1.0 2019-08 Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties
05/29/2024 Radiology 12-358 Complete IEC 63145-20-20 Edition 1.0 2019-09 Eyewear display - Part 20-20: Fundamental measurement methods - Image quality
05/29/2024 Radiology 12-359 Complete IEC 63145-22-10 Edition 1.0 2020-01 Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties
05/29/2024 Radiology 12-360 Complete IEC 63145-10 Edition 1.0 2023-09 Eyewear display - Part 10: Specifications
05/29/2024 Radiology 12-361 Complete ICDM IDMS Version 1.2 May 2023 Information Display Measurements Standard
12/23/2024 Radiology 12-362 Complete IEC 61674 Edition 3.0 2024-07 Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
12/23/2024 Radiology 12-363 Complete NEMA PS 3.1 - 3.20 2024e Digital Imaging and Communications in Medicine (DICOM) Set
12/23/2024 Radiology 12-364 Complete IEC 61223-3-8 Edition 1.0 2024-03 Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
12/23/2024 Radiology 12-365 Complete IEC 60627 Edition 3.0 2013-07 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
12/23/2024 Radiology 12-366 Complete IEC 61223-3-6 Edition 1.0 2020-02 Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation
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
12/22/2025 Radiology 12-384 Complete ICDM IDMS Version 1.3 May 31 2025 Information Display Measurements Standard
12/22/2025 Radiology 12-385 Complete NEMA PS 3.1 - 3.20 2025d Digital Imaging and Communications in Medicine (DICOM) Set
05/25/2026 Radiology 12-386 Complete IEC 63465 Edition 1.0 2026-01 Calibration and quality control in the use of radionuclide calibrators
01/15/2013 Software/
Informatics		 13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
01/15/2013 Software/
Informatics		 13-34 Complete ANSI AAMI IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1 Edition 1.0 2009-09 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
01/15/2013 Software/
Informatics		 13-35 Complete ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
01/15/2013 Software/
Informatics		 13-36 Complete AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
08/06/2013 Software/
Informatics		 13-40 Complete ANSI AAMI IEC TIR 80001-2-1 2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples
IEC TR 80001-2-1 Edition 1.0 2012-07 Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
08/06/2013 Software/
Informatics		 13-42 Complete ANSI AAMI IEC TIR 80001-2-2:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TR 80001-2-2 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
08/06/2013 Software/
Informatics		 13-44 Complete ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
08/06/2013 Software/
Informatics		 13-49 Complete ISO IEEE 11073-20101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
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)
08/06/2013 Software/
Informatics		 13-56 Complete ISO IEEE 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
08/06/2013 Software/
Informatics		 13-59 Complete ISO IEC IEEE 15026-4 First edition 2021-10-01 Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
08/06/2013 Software/
Informatics		 13-60 Complete IEC TS 62443-1-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
08/06/2013 Software/
Informatics		 13-61 Complete IEC 62443-2-1 Edition 1.0 2010-11 Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
08/06/2013 Software/
Informatics		 13-62 Complete IEC TR 62443-3-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
01/30/2014 Software/
Informatics		 13-63 Complete ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
07/09/2014 Software/
Informatics		 13-65 Complete UL ANSI 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
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
07/09/2014 Software/
Informatics		 13-68 Complete ISO 11073-90101 First edition 2008-01-15 Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test
07/09/2014 Software/
Informatics		 13-69 Complete ISO IEEE 11073-10472 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor
01/27/2015 Software/
Informatics		 13-70 Complete ANSI AAMI IEC TIR80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
IEC TR 80001-2-5 Edition 1.0 2014-12 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
01/27/2015 Software/
Informatics		 13-71 Partial RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
01/27/2015 Software/
Informatics		 13-72 Complete ISO IEEE 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
08/14/2015 Software/
Informatics		 13-73 Partial IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
08/14/2015 Software/
Informatics		 13-74 Complete IEEE Std 11073-10424-2014 Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
08/14/2015 Software/
Informatics		 13-75 Complete ISO IEEE 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/14/2015 Software/
Informatics		 13-76 Complete ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
08/14/2015 Software/
Informatics		 13-77 Complete ISO IEC 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
08/14/2015 Software/
Informatics		 13-78 Complete INCITS ISO IEC 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
01/14/2019 Software/
Informatics		 13-79 Complete IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
04/04/2016 Software/
Informatics		 13-81 Complete ISO IEEE 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
06/27/2016 Software/
Informatics		 13-82 Complete ANSI AAMI ISO TIR 80001-2-6:2014 Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
06/27/2016 Software/
Informatics		 13-83 Complete AAMI TIR57:2016 Principles for medical device security - Risk management.
06/27/2016 Software/
Informatics		 13-84 Complete ISO IEEE 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
12/23/2016 Software/
Informatics		 13-86 Complete ISO IEC 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
12/23/2016 Software/
Informatics		 13-87 Complete ISO IEC 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
08/21/2017 Software/
Informatics		 13-90 Complete ISO IEEE 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
IEEE Std 11073-10417-2015 Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
08/21/2017 Software/
Informatics		 13-92 Partial ISO IEEE 11073-10421 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/21/2017 Software/
Informatics		 13-93 Complete ISO IEEE 11073-10422:2017 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
08/21/2017 Software/
Informatics		 13-94 Complete ISO IEEE 11073-10424 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
08/21/2017 Software/
Informatics		 13-96 Complete UL ANSI 2900-1 First Edition 2017 Standard for Safety, Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
08/21/2017 Software/
Informatics		 13-97 Complete IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
12/04/2017 Software/
Informatics		 13-98 Complete ISO IEC 646 Third edition 1991-12-15 (R2018) Information technology - ISO 7-bit coded character set for information interchange
INCITS ISO IEC 646:1991 (R2018) Information technology - ISO 7-bit coded character set for information interchange
12/04/2017 Software/
Informatics		 13-99 Complete ISO IEC 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
12/04/2017 Software/
Informatics		 13-100 Complete ISO IEC 15459-4 Third edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
12/04/2017 Software/
Informatics		 13-101 Complete ISO IEC 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
12/04/2017 Software/
Informatics		 13-102 Complete IEC TR 80001-2-8 Edition 1.0 2016-05 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
12/04/2017 Software/
Informatics		 13-103 Complete IEC TR 80001-2-9 Edition 1.0 2017-01 Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
06/07/2018 Software/
Informatics		 13-104 Complete UL ANSI 2900-2-1 First Edition 2017 Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
01/14/2019 Software/
Informatics		 13-105 Complete ANSI AAMI SW91:2018 Classification of defects in health software
01/14/2019 Software/
Informatics		 13-106 Complete ISO IEEE 11073-10207-2019 Health informatics - Point-of-care medical device communication Part 10207: Domain information and service model for service-oriented point-of-care medical device communication
IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
01/14/2019 Software/
Informatics		 13-107 Complete ISO IEEE 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services
07/15/2019 Software/
Informatics		 13-108 Complete IEEE Std 11073-20701-2018 Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding
12/23/2019 Software/
Informatics		 13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
12/23/2019 Software/
Informatics		 13-112 Complete AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
07/06/2020 Software/
Informatics		 13-113 Complete IEEE Std 11073-20601-2019 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
 
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