T/UNP 783-2025 Active Group standards

T/UNP 783-2025 Technical specification for medical device information traceability system

Publish Date: 2025-07-23 Implement Date: 2025-07-23 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/UNP 783-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Comprehensive Application of Information Technology

Publish Date: 2025-07-23

Implement Date: 2025-07-23

Scope

This standard specifies the general principles, architecture, functions, data, security, and implementation and maintenance requirements of the medical device information traceability system. The system adopts a multi-layered distributed architecture, including data collection, transmission, processing, application, and user layers, supporting multiple identification methods and deployment modes. The functions cover traceability information management, early warning, data analysis and reporting, and system management, covering the entire life cycle of information. Data needs to be classified and standardized to ensure the security of storage and sharing. Security aspects involve data, network, and system security. Implementation and maintenance require planning, training, and daily operation and maintenance. It is applicable to the construction of traceability systems in production, operation, and use processes.