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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)
 
12/19/2022 Software/
Informatics		 13-128 Complete IEEE UL Std 2621.2-2022 Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions
12/19/2022 Software/
Informatics		 13-123 Complete ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
12/19/2022 Software/
Informatics		 13-124 Complete AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
12/19/2022 Software/
Informatics		 13-125 Complete ANSI AAMI UL 2800-1-1:2022 Standard for Risk Concerns for Interoperable Medical Products
12/23/2019 Software/
Informatics		 13-112 Complete AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
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		 13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
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
12/04/2017 Software/
Informatics		 13-98 Complete ISO IEC 646 Third edition 1991-12-15 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
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
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
01/14/2019 Software/
Informatics		 13-105 Complete ANSI AAMI SW91:2018 Classification of defects in health software
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
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
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		 13-102 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
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
05/25/2026 Software/
Informatics		 13-157 Complete IEEE Std 11073-10207-2017 [Including Cor 1-2025] Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication [Including Corrigendum 1 (2025)]
12/22/2025 Software/
Informatics		 13-151 Complete ISO IEEE 11073-10421 Second Edition 2024-08 Health informatics - Device Interoperability - Part 10421: Personal health device communication - Device specialization - Peak expiratory flow monitor (peak flow)
IEEE Std 11073-10421-2023 Health Informatics-Device Interoperability - Part 10421: Personal Health Device Communication - Device Specialization - Peak expiratory flow monitor (peak flow)
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
12/22/2025 Software/
Informatics		 13-152 Complete ISO TS 5615:2025 Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics
12/23/2024 Software/
Informatics		 13-141 Complete ISO IEEE 11073-10701 First Edition, 2024-09 Health Informatics - Device Interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System
IEEE Std 11073-10701-2022 Health informatics - Device interoperability Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system
06/27/2016 Software/
Informatics		 13-83 Complete AAMI TIR57:2016 Principles for medical device security - Risk management.
12/22/2025 Software/
Informatics		 13-155 Complete IEEE Std 11073-10442-2023 Health informatics - Device Interoperability Part 10442: Personal health device communication - Device specialization - Strength fitness equipment
05/25/2026 Software/
Informatics		 13-158 Complete IEEE Std 1752.1-2021 Open Mobile Health Data: Representation of Metadata, Sleep, and Physical Activity Measures
12/22/2025 Software/
Informatics		 13-156 Complete ISO IEEE 11073-10471 Second Edition 2024-09 Health Informatics - Device Interoperability - Part 10471: Personal Health Device Communication - Device Specialization-Independent Living Activity Hub
IEEE Std 11073-10471-2023 Health Informatics - Device interoperability - Part 10471: Personal health device communication - Device specialization - Independent living activity hub
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
05/25/2026 Software/
Informatics		 13-140 Complete FIRST CVSS v4.0 Common Vulnerability Scoring System version 4.0
12/22/2025 Software/
Informatics		 13-153 Complete AAMI CR515:2025 Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices
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
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
05/26/2025 Software/
Informatics		 13-142 Complete FIRST CVSS v3.1 Common Vulnerability Scoring System version 3.1
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
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
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
08/06/2013 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		 13-40 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		 13-61 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
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
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
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
12/22/2025 Software/
Informatics		 13-154 Complete IEEE Std 11073-10429-2022 Health informatics - Device Interoperability - Part 10429: Personal Health Device Communication - Device Specialization - Spirometry
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
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
08/14/2015 Software/
Informatics		 13-76 Complete ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
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]
08/14/2015 Software/
Informatics		 13-77 Complete ISO IEC 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
08/14/2015 Software/
Informatics		 13-75 Complete ISO IEEE 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/21/2017 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)]
07/06/2020 Software/
Informatics		 13-115 Complete ISO IEC IEEE 29119-1 First edition 2013-09-01 Software and systems engineering - Software testing - Part 1: Concepts and definitions
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)]
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
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
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)
08/21/2017 Software/
Informatics		 13-97 Complete IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
12/22/2025 Software/
Informatics		 13-150 Complete ISO IEEE 11073-10472 Second edition 2024-09 Health informatics - Device Interoperability - Part 10472: Personal health device communication - Device specialization - Medication monitor
IEEE Std 11073-10472-2023 Health informatics - Device Interoperability - Part 10472: Personal Health Device Communication - Device Specialization - Medication Monitor
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
01/30/2014 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
07/15/2019 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
01/27/2015 Software/
Informatics		 13-71 Partial RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
07/06/2020 Software/
Informatics		 13-114 Complete IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
05/29/2024 Software/
Informatics		 13-134 Complete ISO IEEE 11073-10404 Second edition 2022-12 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
IEEE Std 11073-10404-2020 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
05/29/2024 Software/
Informatics		 13-133 Complete ISO IEEE 11073-10415 Second edition 2022-12 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
IEEE Std 11073-10415-2019 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
12/19/2022 Software/
Informatics		 13-127 Complete ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
05/29/2024 Software/
Informatics		 13-132 Complete ISO IEEE 11073-10408 Second edition 2022-12 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
IEEE Std 11073-10408-2019 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
12/19/2022 Software/
Informatics		 13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
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)
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.
08/14/2015 Software/
Informatics		 13-73 Partial IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
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
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
04/04/2016 Radiology 12-195 Complete NEMA MS 6-2008 (R2014, R2020) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
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
03/16/2012 Radiology 12-106 Complete ISO 17526 First edition 2003-06-15 Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
03/16/2012 Radiology 12-246 Complete ISO 21254-2 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination
03/16/2012 Radiology 12-245 Complete ISO 21254-1 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
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 12-354 Complete NEMA MS 4-2023 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
03/16/2012 Radiology 12-105 Complete NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
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
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
12/19/2007 Radiology 12-171 Complete ISO 14880-2:2006 Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
04/04/2016 Radiology 12-188 Complete NEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
04/04/2016 Radiology 12-187 Complete NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
07/09/2014 Radiology 12-282 Complete ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
09/17/2018 Radiology 12-320 Complete IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
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
05/29/2024 Radiology 12-360 Complete IEC 63145-10 Edition 1.0 2023-09 Eyewear display - Part 10: Specifications
07/09/2014 Radiology 12-194 Complete ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
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
04/04/2016 Radiology 12-196 Complete NEMA MS 2-2008 (R2020) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
10/04/2010 Radiology 12-214 Complete IEC 62220-1-3 Edition 1.0 2008-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
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
12/04/2017 Radiology 12-307 Complete AAMI RT2:2017 Radiation therapy readiness check
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
03/16/2012 Radiology 12-241 Complete IEC 62274 First Edition 2005-05 Medical electrical equipment - Safety of radiotherapy record and verify systems
08/06/2013 Radiology 12-255 Complete IEC 60601-2-11 Edition 3.0 2013-01 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
01/14/2019 Radiology 12-322 Complete NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
06/07/2021 Radiology 12-336 Complete IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
 
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