DANSK DSF/IEC TR 60601-4-5 ED1 PDF

This document provides detailed technical specifications for SECURITY features of MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT) AND MEDICAL ELECTRICAL SYSTEMS (ME SYSTEMS) used in MEDICAL IT-NETWORKS. MEDICAL DEVICE SOFTWARE although not in the scope of the IEC 60601 series may also make use of this document. Based on the seven Foundational Requirements described in the state-of-the-art document IEC TS 62443-1-1 [4], this document provides specifications for different MEDICAL DEVICE capability SECURITY LEVELS (SL-C). The specified SECURITY capabilities of a MEDICAL DEVICE may be used by various members of the medical community to integrate the device correctly into defined SECURITY ZONES and CONDUITS of a MEDICAL IT-NETWORK with an appropriate MEDICAL IT-NETWORK’S target SECURITY LEVEL (SL-T). This document is applicable to MEDICAL DEVICES with external data interface(s), e.g. when connected to a MEDICAL IT-NETWORK or when a human interface is used for processing – e.g. entering, capturing or viewing – CONFIDENTIAL PATIENT data. MEDICAL DEVICES dealt with in this document include MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS and MEDICAL DEVICE SOFTWARE. This document does not apply to other software used on a MEDICAL IT-NETWORK which does not meet the definition of MEDICAL DEVICE SOFTWARE. NOTE: Examples of these exclusions are software not incorporated into the MEDICAL DEVICE and industry protocols (e.g. DICOM, HL7). This document does not apply to In-Vitro Diagnostic Devices (IVD).