主要技术内容
本标准规定了全自动化学发光免疫分析仪的结构与分类、工作条件、技术要求、试验方法、检验规则、标签、标志、包装、运输和贮存等内容，适用于该类分析仪的生产与检验。分类按反应体系设计分为非均相和均相，按试剂存储形态分为湿式和干式，结构包括主机（含样本架输送等模块）及附属部件。工作条件对电源、环境温度、湿度等有具体要求，技术要求涵盖外观、性能、加样准确度与重复性等多方面，试验方法涉及目视检验、操作观察及各类指标的测定步骤，检验规则分为出厂检验和型式检验，标签、标志、包装、运输和贮存也有详细规定，旨在规范该类仪器的全流程，为生产与检验提供统一技术依据。
This standard specifies the structure and classification, working conditions, technical
requirements, test methods, inspection rules, labels, marks, packaging, transportation and
storage of fully automatic chemiluminescence immunoassay analyzers, and is applicable to the
production and inspection of such analyzers. In terms of classification, it is divided into
heterogeneous and homogeneous according to the design of the reaction system, and into wet
and dry types according to the storage form of reagents. The structure includes the main
machine (with modules such as sample rack conveying) and auxiliary components. The
working conditions have specific requirements for power supply, ambient temperature, humidity,
etc. The technical requirements cover multiple aspects such as appearance, performance,
sample addition accuracy and repeatability. The test methods involve visual inspection,
operational observation and measurement procedures for various indicators. The inspection
rules are divided into factory inspection and type inspection. Labels, marks, packaging,
transportation and storage are also specified in detail, aiming to standardize the whole process of
such instruments and provide a unified technical basis for production and inspection.
适用范围
是否包含专利
否
