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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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 Software/
Informatics		 13-146 Complete IEEE Std 11073-10103 Second edition 2023 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
12/19/2022 Software/
Informatics		 13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
12/19/2022 Software/
Informatics		 13-127 Complete ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
12/19/2022 Software/
Informatics		 13-121 Complete ANSI AAMI UL 2800-1:2022 Standard for Medical Device Interoperability
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
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
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
12/19/2022 Software/
Informatics		 13-128 Complete IEEE UL Std 2621.2-2022 Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions
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)
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
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
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)
10/19/2020 Software/
Informatics		 13-116 Complete FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
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
01/15/2013 Software/
Informatics		 13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
06/07/2021 Software/
Informatics		 13-119 Complete ANSI ISA 62443-4-1-2018 Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements.
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		 13-147 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)
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
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
05/25/2026 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
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
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
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)]
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
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		 13-44 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
01/27/2015 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
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
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
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
12/22/2025 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)
08/21/2017 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
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
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		 13-102 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
12/22/2025 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
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		 13-42 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
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)]
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
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
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
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
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
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
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
06/07/2021 Software/
Informatics		 13-118 Complete IEEE Std 11073-40102:2020 Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation.
05/29/2024 Software/
Informatics		 13-139 Complete ISO IEEE 11073-10206:2024 Health informatics - Device interoperability Part 10206: Personal health device communication - Abstract content information model
IEEE Std 11073-10206-2022 Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model
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
08/06/2013 Software/
Informatics		 13-53 Complete ISO IEEE 11073-10415 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
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.
10/09/2023 Software/
Informatics		 13-131 Complete ANSI AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers
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
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
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
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
08/06/2013 Software/
Informatics		 13-57 Complete ISO IEEE 11073-10407 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
IEEE Std 11073-10407-2008 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
01/27/2015 Software/
Informatics		 13-71 Partial RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
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.
08/21/2017 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)
08/06/2013 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
IEEE Std 11073-10404-2008 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
08/14/2015 Software/
Informatics		 13-73 Partial IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
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
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
01/14/2014 Radiology 12-268 Complete IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
01/30/2014 Radiology 12-59 Complete IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/30/2014 Radiology 12-264 Complete NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
06/07/2018 Radiology 12-312 Complete IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
06/07/2018 Radiology 12-313 Complete IEC TS 62462 Edition 2.0 2017-07 Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
09/09/2008 Radiology 12-165 Complete NEMA XR 22-2006 (R2020) "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
06/07/2018 Radiology 12-314 Complete ISO 11554 Fourth edition 2017-07 Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal 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
07/09/2014 Radiology 12-283 Complete ISO 12609-2 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
03/14/2011 Radiology 12-226 Complete IEC 61223-2-6 Second Edition 2006-11 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
03/16/2012 Radiology 12-105 Complete NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
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 12-272 Complete IEC 60601-2-17 Edition 3.0 2013-11 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
08/14/2015 Radiology 12-292 Complete IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
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 12-360 Complete IEC 63145-10 Edition 1.0 2023-09 Eyewear display - Part 10: Specifications
03/16/2012 Radiology 12-242 Complete IEC 60601-2-57 Edition 1.0 2011-01 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 and cosmetic/aesthetic use
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 12-232 Complete NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
12/23/2019 Radiology 12-329 Complete IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
03/31/2006 Radiology 12-138 Complete ISO 5799 Second edition 1991-08-01 Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
01/14/2019 Radiology 12-322 Complete NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
07/09/2014 Radiology 12-281 Complete IEC 60601-2-62 Edition 1.0 2013-07 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
 
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