PD IEC TR 60601-4-5:2021 pdf free

PD IEC TR 60601-4-5:2021 pdf free.Medical electrical equipment Part 4-5: Guidance and interpretation一Safety- related technical security specifications.
This document, which is a Technical Report, provides detailed technical specifications for SECURITY features of MEDICAL DEVICES used in MEDICAL IT-NETWORKS. MEDICAL DEVICES dealt with in this document include MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS and MEDICAL DEVICE SOFTWARE. MEDICAL DEVICE SOFTWARE, although not in the scope of IEC 60601 (all parts), can also make use of this document. Based on the seven foundational requirements described in the state-of-the-art document IEC TS 62443-1-1:2009 [4), this document provides specifications for different MEDICAL DEVICE capability SECURITY LEVELS (SL-C). The specified SECURITY capabilities of a MEDICAL DEVICE can 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), for example when connected to a MEDICAL IT-NETWORK or when a human interface is used for processing — e.g. entering, capturing or viewing — CONFIDENTIAL DATA.
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 I An example ol this exclusion is software not incorporated into the MEDICAL DEVICE, NOTE 2 This document does also not apply to industry protocols such as DICOM and HL7. This document does not apply to in-vitro diagnostic devices (IVO).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
Constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 60601-1:2005. Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 62443-4-2:2019, Security for industrial automation and control systems — Part 4-2 Technical security requirements for IACS components.PD IEC TR 60601-4-5 pdf free download.