Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
351 to 400 of 1554 Results
 < 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 > 
Results per Page
New Search export reports to excelExport to Excel HelpStandards Search Assistance
Date of
Entry
Sort by Date [Old to new]
Sort by Date [New to old]
Specialty Task
Group Area
Sort by Specialty Task Group Area [A-Z]
Sort by Specialty Task Group Area [Z-A]
Recognition
Number
Sort by Recognition Number [0-9]
Sort by Recognition Number [9-0]
Extent of
Recognition
Sort by Extent of Recognition [A-Z]
Sort by Extent of Recognition [Z-A]
Standards
Developing
Organization

Standard Designation
Number and Date
 

Standard Title
(click for recognition information)
 
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
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		 13-60 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		 13-59 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		 13-57 Complete ISO IEEE 11073-10407 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
08/06/2013 Software/
Informatics		 13-56 Complete IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
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		 13-54 Partial ISO IEEE 11073-10404 First edition 2010-05-01 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
08/06/2013 Software/
Informatics		 13-52 Complete ISO IEEE 11073-10408 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
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		 13-44 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		 13-42 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		 13-40 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		 13-38 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		 13-37 Complete CLSI AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
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
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
05/29/2024 Radiology 12-361 Complete ICDM IDMS Version 1.2 May 2023 Information Display Measurements Standard
05/29/2024 Radiology 12-360 Complete IEC 63145-10 Edition 1.0 2023-09 Eyewear display - Part 10: Specifications
05/29/2024 Radiology 12-359 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 12-358 Complete IEC 63145-20-20 Edition 1.0 2019-09 Eyewear display - Part 20-20: Fundamental measurement methods - Image quality
05/29/2024 Radiology 12-357 Complete IEC 63145-20-10 Edition 1.0 2019-08 Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties
05/29/2024 Radiology 12-356 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 12-355 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 12-354 Complete NEMA MS 4-2023 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
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
 
 < 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 > 
 
-
-