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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)
 
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		 13-34 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		 13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
08/20/2012 Software/
Informatics		 13-31 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
03/16/2012 Software/
Informatics		 13-30 Complete CLSI AUTO3-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
09/08/2009 Software/
Informatics		 13-29 Complete CLSI LIS01-A2 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
03/18/2009 Software/
Informatics		 13-28 Complete CLSI AUTO9-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
03/18/2009 Software/
Informatics		 13-26 Complete CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
03/18/2009 Software/
Informatics		 13-25 Complete CLSI AUTO8-A Managing and Validating Laboratory Information Systems; Approved Guideline
09/09/2008 Software/
Informatics		 13-24 Complete CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
09/09/2008 Software/
Informatics		 13-23 Complete CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
09/09/2008 Software/
Informatics		 13-22 Complete CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
09/09/2008 Software/
Informatics		 13-21 Complete CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
09/09/2008 Software/
Informatics		 13-20 Complete CLSI LIS05-A Standand Specification for Transferring Clinical Observations Between Independent Computer Systems
09/09/2008 Software/
Informatics		 13-19 Complete CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems
09/09/2008 Software/
Informatics		 13-18 Complete CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System
09/09/2008 Software/
Informatics		 13-17 Complete CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition
07/09/2014 Software/
Informatics		 13-15 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
09/09/2008 Software/
Informatics		 13-14 Complete CLSI POCT1-A2 Point-of-Care Connectivity
09/09/2008 Software/
Informatics		 13-13 Complete CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
09/09/2008 Software/
Informatics		 13-12 Complete CLSI AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
09/09/2008 Software/
Informatics		 13-10 Complete CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
09/09/2008 Software/
Informatics		 13-9 Complete CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification
12/18/2023 Radiology 12-353 Partial ANSI Z136.1-2022 American National Standard for Safe Use of Lasers
12/18/2023 Radiology 12-352 Complete NEMA PS 3.1 - 3.20 2023e Digital Imaging and Communications in Medicine (DICOM) Set
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
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
12/19/2022 Radiology 12-349 Complete NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set
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 12-347 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
12/19/2022 Radiology 12-346 Complete ISO 12005 Third edition 2022-05 Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
05/30/2022 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
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 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
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
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
06/07/2021 Radiology 12-339 Complete IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
06/07/2021 Radiology 12-338 Complete 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 12-337 Complete NEMA NU 1-2018 Performance Measurements of Gamma Cameras
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
06/07/2021 Radiology 12-335 Complete IEC 60336 Edition 5.0 2020-12 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
07/06/2020 Radiology 12-334 Complete AAMI RT3:2020 Radiation therapy machine characterization
07/06/2020 Radiology 12-333 Complete IEC TR 63183 Edition 1.0 2019-12 Guidance on error and warning messages for software used in radiotherapy
07/06/2020 Radiology 12-332 Complete IEC 62464-1 Edition 2.0 2018-12 Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
07/06/2020 Radiology 12-331 Complete NEMA Standards Publication MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
07/06/2020 Radiology 12-330 Complete NEMA Standards Publication XR 28-2018 Supplemental Requirements for User Information and System Function Related to Dose in CT
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
12/23/2019 Radiology 12-328 Complete IEC 61223-3-5 Edition 2.0 2019-09 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
12/23/2019 Radiology 12-327 Complete ISO 11551 Third eidtion 2019-10 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
07/15/2019 Radiology 12-326 Complete NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs
 
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