本文件是一份技术报告，为医疗IT网络中使用的医疗设备的安全功能提供了详细的技术规范。本文件涉及的医疗设备包括医疗电气设备、医疗电气系统和医疗设备软件。医疗器械软件虽然不在IEC 60601（所有部分）的范围内，但也可以使用本文件。基于最新文件IEC TS 62443-1中描述的七项基本要求- 1:2009[4]，本文件提供了不同医疗设备能力安全级别的规范 （SL-C）。医疗机构的不同成员可以使用医疗设备的特定安全功能，将设备正确地集成到医疗IT网络的定义安全区域和管道中，并具有适当的医疗IT网络目标安全级别（SL-T）。购买本文件时可获得的所有当前修订均包含在购买本文件中。

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).All current amendments available at time of purchase are included with the purchase of this document.