CLSI AUTO11

Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 2nd Edition

Do you need to understand IT security requirements for your laboratory systems? Learn how to communicate with your IVD system vendor about security issues such as malicious software with AUTO11.

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Chairholder: Ed Heierman III, PhD

Date of Publication: October 31, 2014

Order Code PDF: CLSI AUTO11A2E
ISBN Number: 1-56238-980-7

Order Code Print: print not available

Edition: Second

Pages: 64

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI AUTO11 Abstract

Clinical and Laboratory Standards Institute document AUTO11-A2—Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard—Second Edition 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 organization (HCO). The intended users for this standard are vendors (IVD system manufacturers), users (eg, laboratory personnel), and information technology management of HCOs.