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Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition

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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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Details

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.

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