T/ZMDS 20003-2019 (English Version) PDF

Scope: This standard defines the network security capabilities involved in medical device network security risk control. It stipulates the information that medical device manufacturers should disclose when communicating with parties responsible for medical device network security. Network security capabilities include a total of 20 items, namely: automatic logout capabilities, audit control capabilities, the ability to determine user authorization, security feature configuration capabilities, network security upgrade capabilities, health data identity information removal capabilities, data backup and disaster recovery capabilities, The ability to urgently access private data, data integrity and authenticity confirmation, malware detection and protection, network node identification, personnel identification, physical lock protection, third-party component maintenance, system and application reinforcement, and The ability of operators and administrators to provide network security guidance, storage confidentiality capabilities, transmission confidentiality capabilities, the ability to ensure data transmission integrity, and other network security capabilities

T/ZMDS 20003-2019 history

2019 T/ZMDS 20003-2019 Medical device security risk control – information of medical device security capabilities