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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
08/21/2017 Software/
Informatics		 13-93 IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
08/21/2017 Software/
Informatics		 13-97 IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
01/15/2013 Software/
Informatics		 13-33 AAMI TIR 36:2007 Validation of software for regulated processes
08/14/2015 Software/
Informatics		 13-78 IEC INCITS ISO 30111 First edition 2013-11-01 (R2019) Information technology - Security techniques - Vulnerability handling processes
03/18/2009 Software/
Informatics		 13-25 CLSI AUTO8-A Managing and Validating Laboratory Information Systems; Approved Guideline
03/18/2009 Software/
Informatics		 13-26 CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
03/18/2009 Software/
Informatics		 13-28 CLSI AUTO9-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
09/09/2008 Software/
Informatics		 13-9 CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification
01/27/2015 Software/
Informatics		 13-70 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
08/14/2015 Software/
Informatics		 13-75 IEEE ISO 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
06/27/2016 Software/
Informatics		 13-82 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 AAMI TIR57:2016 Principles for medical device security - Risk management.
06/07/2018 Software/
Informatics		 13-104 ANSI UL 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
10/19/2020 Software/
Informatics		 13-116 FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
08/20/2012 Software/
Informatics		 13-31 CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
08/21/2017 Software/
Informatics		 13-90 IEEE Std 11073-10417-2015 Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
09/09/2008 Software/
Informatics		 13-10 CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
03/16/2012 Software/
Informatics		 13-30 CLSI AUTO3-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
01/15/2013 Software/
Informatics		 13-36 AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software
08/06/2013 Software/
Informatics		 13-60 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		 13-62 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
12/19/2022 Software/
Informatics		 13-125 AAMI ANSI UL 2800-1-1:2022 Standard for Risk Concerns for Interoperable Medical Products
12/19/2022 Software/
Informatics		 13-127 AAMI ANSI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
12/19/2022 Software/
Informatics		 13-121 AAMI ANSI UL 2800-1:2022 Standard for Medical Device Interoperability
12/20/2021 Software/
Informatics		 13-120 ANSI AAMI 2700-1:2019 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
12/04/2017 Software/
Informatics		 13-100 IEC ISO 15459-4 Third edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
08/21/2017 Software/
Informatics		 13-95 IEEE ISO 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
01/15/2013 Software/
Informatics		 13-35 ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
09/09/2008 Software/
Informatics		 13-13 CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
09/09/2008 Software/
Informatics		 13-14 CLSI POCT1-A2 Point-of-Care Connectivity
09/09/2008 Software/
Informatics		 13-17 CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition
09/09/2008 Software/
Informatics		 13-19 CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems
09/09/2008 Software/
Informatics		 13-20 CLSI LIS05-A Standand Specification for Transferring Clinical Observations Between Independent Computer Systems
09/09/2008 Software/
Informatics		 13-21 CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
09/09/2008 Software/
Informatics		 13-22 CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
09/09/2008 Software/
Informatics		 13-23 CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
09/09/2008 Software/
Informatics		 13-24 CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
12/19/2022 Software/
Informatics		 13-122 IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022 Software/
Informatics		 13-123 ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
12/19/2022 Software/
Informatics		 13-124 AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
01/27/2015 Software/
Informatics		 13-72 IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
07/15/2019 Software/
Informatics		 13-109 AAMI ANSI UL 2800-1:2019 Standard for Safety for Medical Device Interoperability
12/23/2016 Software/
Informatics		 13-85 CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
08/06/2013 Software/
Informatics		 13-37 CLSI AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
08/06/2013 Software/
Informatics		 13-52 IEEE ISO 11073-10408 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
06/27/2016 Software/
Informatics		 13-84 IEEE ISO 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 IEEE Std 2621.2-2022 Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions
06/07/2021 Software/
Informatics		 13-119 ANSI ISA 62443-4-1-2018 Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements.
08/21/2017 Software/
Informatics		 13-92 IEEE ISO 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 IEEE ISO 11073-10404 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
06/07/2021 Software/
Informatics		 13-117 IEEE Std 11073-40101-2020 Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment.
08/14/2015 Software/
Informatics		 13-73 IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
01/27/2015 Software/
Informatics		 13-71 RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
12/19/2022 Radiology 12-348 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
06/27/2016 Radiology 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
06/27/2016 Radiology 12-302 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
06/07/2018 Radiology 12-310 IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
05/30/2022 Radiology 12-343 IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
07/09/2014 Radiology 12-277 IEC 62127-1 Edition 1.1 2013-02 Ultrasonics -- Hydrophones -- Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
07/09/2014 Radiology 12-282 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
06/07/2018 Radiology 12-311 IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
01/14/2014 Radiology 12-269 IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
06/07/2021 Radiology 12-337 NEMA NU 1-2018 Performance Measurements of Gamma Cameras
06/07/2021 Radiology 12-338 IEC 60601-2-1 Edition 4.0 2020-10 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
06/07/2021 Radiology 12-336 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
01/27/2015 Radiology 12-287 NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
07/06/2020 Radiology 12-331 NEMA Standards Publication MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
05/30/2022 Radiology 12-344 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
01/30/2014 Radiology 12-59 IEC 61168:1993 Radiotherapy simulators - Functional performance characteristics
01/30/2014 Radiology 12-264 NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
08/06/2013 Radiology 12-211 IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
06/07/2018 Radiology 12-314 ISO 11554 Fourth edition 2017-07 Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics
06/07/2018 Radiology 12-312 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 IEC TS 62462 Edition 2.0 2017-07 Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems
08/06/2013 Radiology 12-205 IEC 60601-2-5: Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
07/12/1999 Radiology 12-51 IEC 61145 (1992-05) Calibration and usage of ionization chamber systems for assay of radionuclides
08/14/2015 Radiology 12-291 IEC 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
06/07/2021 Radiology 12-340 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
08/21/2017 Radiology 12-306 NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
01/27/2015 Radiology 12-230 NEMA XR 24-2008 (R2014) Primary user controls for interventional angiography x-ray equipment
01/27/2015 Radiology 12-286 NEMA XR 27 Amendment 1-2013 X-ray equipment for interventional procedures - User Quality Control Mode
06/27/2016 Radiology 12-294 IEC 60601-2-45 Edition 3.1 2015 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
04/04/2016 Radiology 12-288 NEMA MS 9-2008 (R2020) Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
06/07/2018 Radiology 12-316 IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
03/31/2006 Radiology 12-136 ISO 9236-1 Second edition 2004-02-01 Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
11/08/2005 Radiology 12-6 IEC 60806 First edition 1984-01 Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
12/19/2022 Radiology 12-349 NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set
12/20/2021 Radiology 12-342 NEMA PS 3.1 - 3.20 2021e Digital Imaging and Communications in Medicine (DICOM) Set
12/23/2019 Radiology 12-317 IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
12/19/2022 Radiology 12-346 ISO 12005 Third edition 2022-05 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
03/16/2012 Radiology 12-113 ISO 12005 Second edition 2003-04-01 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
12/19/2022 Radiology 12-347 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
12/20/2021 Radiology 12-341 IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
03/31/2006 Radiology 12-141 IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
03/16/2012 Radiology 12-106 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 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 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
08/14/2015 Radiology 12-292 IEEE Std 3333.2.1-2015 IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
07/09/2014 Radiology 12-194 ANSI HPS N43.6-2007 (R2013) Sealed Radioactive Sources - Classification
06/27/2016 Radiology 12-297 ANSI IES RP-27.1-2015 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
 
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