T/CIET 1002-2025 Active Group standards

T/CIET 1002-2025 Biochip analyzer

Publish Date: 2025-01-22 Implement Date: 2025-01-22 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CIET 1002-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical and Health Technology (Vocabulary)

Publish Date: 2025-01-22

Implement Date: 2025-01-22

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.