T/ZMDS 20001-2016 Risk Management in the Introduction of Medical Devices to IT Networks: Part 1: Roles, Responsibilities, and Activities

Scope

Scope: This standard applies to risk management for medical device network responsible parties. This standard does not apply to: pre-market risk management of medical devices; cases where a complete medical device network is provided as a single product; and cases where a single person simultaneously serves as a patient, an operator, and a responsible party. Main technical content: Given the many benefits of connecting medical devices to IT networks, and the need for risk management in terms of safety, effectiveness, and data and system information security (key features), this standard defines the roles, responsibilities, and activities of risk management. This standard is a guidance document for risk management during the process of connecting medical devices to IT networks, and its main content includes terms and definitions (32 items), roles and responsibilities, and risk management throughout the life cycle of medical IT networks.

Development Information

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