GB/T 46302-2025

Upcoming

Automatic sample processing system for medical use

医用全自动样本处理系统

Standard Type
GBT
ICS
11.100.10
CCS
C44
Status
Upcoming
Issue Date
2025-10-05
Implementation
2026-11-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies technical requirements, test methods, and inspection rules for automated systems that handle biological samples (e.g., blood, urine) in medical laboratories. It applies to the design, manufacturing, and quality verification of equipment used for tasks like sample sorting, centrifugation, aliquoting, and barcode labeling in clinical diagnostics and hospital testing environments.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.