ICS 11.100 CCS C 44 湖 DB43 南 省 地 方 标 准 DB43/T 1897—2020 化学发光免疫分析仪用参考光源 通用技术要求 General technical requirements of reference light source for chemiluminescence immunoanalyzer 2020-12-29发布 湖南省市场监督管理局 2021-03-29实施 发 布 DB43/T 1897—2020 目 次 前言 ························································································································ Ⅲ 1 范围 ····················································································································· 1 2 规范性引用文件 ······································································································ 1 3 术语和定义 ············································································································ 1 4 要求 ····················································································································· 1 5 4.1 正常工作条件 ··································································································· 1 4.2 外观 ··············································································································· 2 4.3 重复性 ············································································································ 2 4.4 稳定性 ············································································································ 2 4.5 光源线性 ········································································································· 2 4.6 电气安全 ········································································································· 2 4.7 电磁兼容性 ······································································································ 2 4.8 环境试验 ········································································································· 2 试验方法 ··············································································································· 2 5.1 试验条件 ········································································································· 2 5.2 外观检查 ········································································································· 2 5.3 重复性 ············································································································ 2 5.4 稳定性 ············································································································ 3 5.5 光源线性 ········································································································· 3 5.6 电气安全 ········································································································· 3 5.7 电磁兼容性 ······································································································ 3 5.8 环境试验 ········································································································· 4 6 标志、标签和说明书 ································································································ 4 7 包装、运输和贮存 ··································································································· 4 7.1 包装 ··············································································································· 4 7.2 运输 ··············································································································· 4 7.3 贮存 ··············································································································· 4 I DB43/T 1897—2020 II DB43/T 1897—2020 前 言 本文件按照 GB/T 1.1—2020 给出的规则起草。 本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。 本文件由湖南省药品监督管理局提出并归口。 本文件起草单位：湖南省医疗器械检验检测所、湖南乐准智芯生物科技有限公司。 本文件起草人：邓振进、黄海萍、周阳、曹俐、吴碧涛、刘向荣、姚健、彭明霞、周宇、刘鹏举、 彭再明、陈新平、邬鹏程、高飞、琚新军、林云峰。 III DB43/T 1897—2020 IV DB43/T 1897—2020 化学发光免疫分析仪用参考光源通用技术要求 1 范围 本文件规定了化学发光免疫分析仪用参考光源的术语和定义、要求、试验方法、标志、标签和说明 书、包装、运输和贮存等内容。 本文件适用于化学发光免疫分析仪用参考光源。 2 规范性引用文件 下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文件， 仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用于本 文件。 GB/T 191—2008 包装储运图示标志 GB 4793.1—2007 测量、控制和实验室用电气设备的安全要求 GB/T 14710—2009 医用电器设备环境要求及试验方法 GB/T 18268.1—2010 YY/T 0466.1—2016 3 第 1 部分：通用要求 测量、控制和实验室用的电设备电磁兼容性要求 医疗器械 用于医疗器械标签、标记和提供信息的符号 第 1 部分：通用要求 术语和定义 下列术语和定义适用于本标准。 3.1 化学发光免疫分析 chemiluminescence immunoassay 是将化学发光和免疫分析结合起来的技术，通过标记的抗原或抗体与待测物进行一系列免疫反应， 最后以测定发光强度得出待测物含量。 3.2 参考光源 reference light source 直接用于化学发光免疫分析仪性能测试的光源。光源光谱半带宽≤30nm，光谱中心波长扩展不确定 度 u=5nm，k=2。 注：光源光谱中心波长应该与化学发光免疫分析仪制造商使用的试剂发光波长相近，如 450nm、470nm、530nm、620nm。