T/ZMDS 20003-2024 Medical device network security risk control and information on medical device network security capabilities

Scope

Scope: This document applies to the following medical device products: 1) Medical device products with network connection capabilities for electronic data exchange or remote control; 2) Medical device products that use storage media for electronic data exchange. This document applies to the following two types of roles: 1) Medical service providers Medical service providers bear the ultimate responsibility for providing effective network security management. Medical service providers should adopt management measures in administrative, physical, and technical aspects to effectively protect medical information security and comply with relevant laws and regulations. Medical service providers can request information related to network security capabilities from medical device manufacturers and refer to this information to implement network security risk management. 2) Medical device manufacturers The impact of medical device manufacturers on the network security capabilities of medical devices is to add network security functions or measures to assist medical service providers in effective network security risk management. Manufacturers should fully evaluate the needs from medical service providers, the intended use of medical devices, usage scenarios, and core functions, and consider the requirements related to network security capabilities described in this document during the R&D, production, installation, and maintenance of medical device products. This document applies to the full life cycle management of medical device network security, including all stages such as design, development, production, installation, maintenance, and decommissioning; Main technical content: This document provides specific definitions of 22 network security capabilities and conducts a questionnaire-style decomposition of these network security capabilities, making it easier for relevant parties to understand the concepts of network security capabilities and implement relevant network

Development Information

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