CLSI AUTO11
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition
CLSI AUTO11 provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care delivery organization.
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Chairholder: Ed Heierman III, PhD; Riccardo L. Benedetti, Dr.sc.techn.ETH, Dipl.El.Ing.ETH
Date of Publication: September 27, 2024
Order Code PDF: CLSI AUTO11Ed3E
ISBN Number: 978-1-68440-253-3
Order Code Print: print not available
Edition: Third
Pages: 100
CLSI AUTO11 Abstract
Clinical and Laboratory Standards Institute AUTO11—Information Technology Security of In Vitro Diagnostic Instruments and Software Systems specifies technical and operational requirements and technical implementation procedures related to security of in vitro diagnostic (IVD) systems (devices, analytical instruments, data management systems, etc.) installed at a health care delivery organization (HDO). The intended users for CLSI AUTO11 are medical device and IVD system manufacturers, users (eg, laboratory personnel), and information technology management of HDOs.