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CLSI 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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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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