【团体标准】 全自动化学发光免疫分析仪通用技术规范

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。Thisstandardspecifiesthestructureandclassification,workingconditions,technicalrequirements,testmethods,inspectionrules,labels,marks,packaging,transportationandstorageoffullyautomaticchemiluminescenceimmunoassayanalyzers,andisapplicabletotheproductionandinspectionofsuchanalyzers.Intermsofclassification,itisdividedintoheterogeneousandhomogeneousaccordingtothedesignofthereactionsystem,andintowetanddrytypesaccordingtothestorageformofreagents.Thestructureincludesthemainmachine(withmodulessuchassamplerackconveying)andauxiliarycomponents.Theworkingconditionshavespecificrequirementsforpowersupply,ambienttemperature,humidity,etc.Thetechnicalrequirementscovermultipleaspectssuchasappearance,performance,sampleadditionaccuracyandrepeatability.Thetestmethodsinvolvevisualinspection,operationalobservationandmeasurementproceduresforvariousindicators.Theinspectionrulesaredividedintofactoryinspectionandtypeinspection.Labels,marks,packaging,transportationandstoragearealsospecifiedindetail,aimingtostandardizethewholeprocessofsuchinstrumentsandprovideaunifiedtechnicalbasisforproductionandinspection.