Q_510114RT001-2020一次性使用口罩.pdf

成都仁天医疗器械有限公司企业标准 Q/510114RT001-2020 一次性使用口罩 2020-03-13 发布 2020-03-14 实施 成都仁天医疗器械有限公司 发 布 目次 前言···························································································II 1. 范围·······················································································1 2. 规范性引用文件···································································1 3. 术语与定义···········································································1 4. 技术要求···············································································1 5. 试验方法···············································································1 6. 检验规则···············································································1 7. 包装标识···············································································1 8. 贮运·······················································································1 1 前 言 本标准按照GB/T 1.1-2009 《标准化工作导则 第1 部分：标准的结构 和编定规则》而起草。 本标准由成都仁天医疗器械有限公司提出并起草。 本标准主要起草人：刘建、卿鹏。 本标准首次发布日期：2020 年03 月14 日。 2 一次性使用口罩 1 范围 本标准规定了一次性使用口罩（以下简称口罩）的术语和定义、 技术要求、测试方法、检验规则及包装、标识及储运。 2 规范性引用文件 下列文件对于本文件的应用是必不可少的。凡是注日期的引用文 件，仅所注日期的版本适用于本文件，凡是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/T32610-2016 日常防护型口罩技术规范 GB15979 一次性使用卫生用品标准 GB2890-2009 呼吸防护自吸过滤式防毒面具 GB/T2912.1 纺织品甲醛的测定第1 部分：游离和水解的甲醛（水 萃取法） GB/T7573 纺织品水萃取液pH 值的测定 GB/T14233.1-2008 医用输液、输血、注射器具检验方法第1 部分： 化学分析法 3 术语和定义 3.1 过滤效率 filter efficiency 在规定检测条件下，口罩罩体滤除颗粒物的能力，用百分数表示。 3.2 微生物 microorganism 自然界中形体微小、结构简单、不能用眼直接观察、须在光学显 3 微镜或电子显微镜下才能看到的微小生