T/CIET 1002-2025 Biochip analyzer
T/CIET 1002-2025 Biochip analyzer
Basic Information
Scope
Scope: This document specifies the requirements, test methods, labels, markings, and user manuals, as well as packaging, transportation, and storage for biochip analyzers used in medical laboratories (hereinafter referred to as "analyzers"). The analyzers employ luminescence systems and immunoassay methods to perform quantitative or qualitative detection of various analytes in human serum, plasma, or other body fluids, including biochip analyzers based on principles such as microarray chemiluminescence, microfluidic chemiluminescence, fluorescence, and colorimetry. Main technical content: This document specifies the requirements, test methods, labels, markings, and user manuals, as well as packaging, transportation, and storage for biochip analyzers used in medical laboratories (hereinafter referred to as "analyzers"). The analyzers employ luminescence systems and immunoassay methods to perform quantitative or qualitative detection of various analytes in human serum, plasma, or other body fluids, including biochip analyzers based on principles such as microarray chemiluminescence, microfluidic chemiluminescence, fluorescence, and colorimetry.