GB/Z 43281-2023

This standard provides operational and supervisory guidance for personnel using point-of-care testing (POCT) devices, such as glucose meters, cardiac marker analyzers, and infectious disease test kits, in clinical settings like hospital wards, emergency rooms, and community health centers. It outlines responsibilities for ensuring test accuracy, device maintenance, quality control, and compliance with regulatory requirements. The standard is applied to improve patient safety and diagnostic reliability in decentralized testing environments where non-laboratory staff perform rapid medical tests.