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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
Recognition
 
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Standard Designation
Number and Date
 
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Title of Standard
 
 
05/20/2019 Software/
Informatics
13-35 ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
01/15/2013 Software/
Informatics
13-34 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 AAMI TIR 36:2007 Validation of software for regulated processes
01/14/2019 Software/
Informatics
13-32 ANSI AAMI IEC 62304:2006 Medical device software - Software life cycle processes
08/20/2012 Software/
Informatics
13-31 CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; 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
09/08/2009 Software/
Informatics
13-29 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 CLSI AUTO9-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
03/18/2009 Software/
Informatics
13-26 CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
03/18/2009 Software/
Informatics
13-25 CLSI AUTO8-A Managing and Validating Laboratory Information Systems; Approved Guideline
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