Autoverification of Clinical Laboratory Test Results (AUTO10-A); IT Security of In Vitro Diagnostic Instruments and Software Systems (AUTO11-A)

AUTO10-A—Autoverification of Clinical Laboratory Test Results; Approved Guideline
This document provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population.
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AUTO11-A— IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard
This document provides a framework for communication of IT security issues between the IVD system vendor and the healthcare organization.
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Our procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community that participates in the consensus process by carefully reviewing and commenting on the standard or guideline.

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