ICS 11.080.10 C 47 FDSA 中国食品药品企业质量安全促进会团体标准 T/FDSA 027—2021 过 氧乙酸低温灭菌器通用技术标准 General technical criteria of peroxyacetic acid low temperature sterilizer 2021 - 1 2 - 14 发布 2021 - 12 - 31 实施 中国食品药品企业质量安全促进会 发 布 N-Vý˜ßTÁƒoTÁO
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N(‘Ï[‰QhOÏÛO 全国团体标准信息平台 T/FDSA 027 —2021 I 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 4.1 正常工作条件 .....................................................................1 4.2 外观与结构 .......................................................................2 4.3 材料 .............................................................................2 4.4 灭菌剂 ...........................................................................2 4.5 灭菌室门和联锁装置 ...............................................................2 4.6 显示装置 .........................................................................2 4.7 记录装置 .........................................................................3 4.8 空气过滤器 .......................................................................3 4.9 灭菌周期及控制 ...................................................................3 4.10 报警 ............................................................................4 4.11 灭菌效果 ........................................................................5 4.12 真空密封性 ......................................................................5 4.13 容积误差 ........................................................................5 4.14 工作噪声 ........................................................................5 4.15 安全要求 ........................................................................5 4.16 环境试验 ........................................................................6 5 试验方法 .............................................................................6 5.1 试验条件 .........................................................................6 5.2 外观和结构试验 ...................................................................6 5.3 材料试验 .........................................................................6 5.4 灭菌剂组成及用量 .................................................................6 5.5 灭菌室门和联锁装置试验 ...........................................................6 5.6 显示装置试验 .....................................................................6 5.7 记录装置试验 .....................................................................6 5.8 空气过滤器试验 ...................................................................6 5.9 灭菌周期及控制试验 ...............................................................6 5.10 报警试验 ........................................................................7 5.11 灭菌效果试验 ....................................................................7 5.12 真空密封性试验 ..................................................................8 5.13 容积误差试验 ....................................................................8 5.14 工作噪声试验 ....................................................................8 5.15 安全要求试验 ....................................................................8 5.16 环境试验 ........................................................................8 N-Vý˜ßTÁƒoTÁO
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N(‘Ï[‰QhOÏÛO 全国团体标准信息平台 T/FDSA 027 —2021 II 6 标志与使用说明书 .....................................................................8 6.1 标 志、标签 .......................................................................8 6.2 使用说明书 .......................................................................9 7 包装、运输、贮存 .....................................................................9 7.1 包装 .................