GB/T 21715.1-2008
Replaced
T/UNP 75-2026
Active
Group standards
T/UNP 75-2026 Specification for clinical evaluation data management of medical devices
T/UNP 75-2026 Specification for clinical evaluation data management of medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/UNP 75-2026
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
The application of information technology in medical and health technologies
Publish Date:
2026-01-30
Implement Date:
2026-01-30
Scope
This standard specifies the requirements for the entire process of data management in clinical evaluation of medical devices, following the principles of compliance with laws and regulations, authenticity and integrity, and traceability. It clarifies the responsibilities of various parties, including sponsors and trial institutions/researchers. It standardizes the management of the entire process of data collection, transmission, and storage, and clearly defines the technical requirements and operating norms for each link. It establishes a full-process quality control system, sets quality objectives such as authenticity and accuracy, and refines quality control measures for each link. At the same time, it proposes security management requirements for systems, networks, and access levels, strengthens the protection of subjects' privacy, and clarifies the scope and retention period of supervision and audit methods and file management requirements.
Development Information
Related Standards
GB/T 21715.2-2008
Replaced
GB/T 21715.2-2008 Health informatics—Patient healthcard data—Part 2:Common objects
GB/T 21715.3-2008
Replaced
GB/T 21715.3-2008 Health informatics—Patient healthcard data—Part 3:Limited clinical data
GB/Z 21716.1-2008
Replaced
GB/Z 21716.1-2008 Health informatics—Public Key Infrastructure (PKI)—Part 1:Overview of digital certificate services
GB/Z 21716.2-2008
Replaced
GB/Z 21716.2-2008 Health informatics—Public Key Infrastructure (PKI)—Part 2:Certificate profile
GB/Z 21716.3-2008
Replaced