T/CRHA 146-2025 Quality Management Requirements for Automated Sample Processing in Human Biological Sample Banks
T/CRHA 146-2025 Automated sample processing quality management requirements for human biobank samples
Basic Information
Scope
Scope: This document specifies the quality management and technical requirements related to the application of automated sample processing equipment in human biological sample banks. This document applies to the quality management of the entire process of establishing automated sample processing systems in human biological sample banks, as well as the conformity assessment of the automated construction and operation processes. This document does not apply to biological sample banks that use automated equipment to process samples from infectious diseases. Main technical content: The overall structure of this document is as follows: 1. Scope; 2. Normative references; 3. Terms and definitions; 4. Quality management requirements; 5. Technical requirements; 6. Information management