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AUTO11-A

IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard


Clinical and Laboratory Standards Institute document AUTO11-A - IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard specifies technical and operational requirements, as well as technical implementation procedures related to security of IVD systems (devices, analytical instruments, data management systems, etc.) installed at a healthcare organization. The intended users for this standard are vendors (IVD system manufacturers), users (e.g., laboratory personnel), and IT management of the healthcare organizations.


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Clinical And Laboratory Standards Institute [clsi]

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