JJF（冀）199-2021 环氧乙烷灭菌设备温度、湿度参数校准规范
简介
JJF（冀）199-2021
环氧乙烷灭菌设备温度、湿度参数校准规范
Calibration Specification for Temperature and Humidity Parameters ofEthylene Oxide Sterilization Equipment
2021-12-01实施
2021-09-16发布 目录 引言...............................................................................................................................................1 1 范围........................................................................................................................................... 1 2 引用文件................................................................................................................................... 1 3 术语和定义............................................................................................................................... 1 3.1 环氧乙烷灭菌设备................................................................................................................ 1 3.2 标称值.................................................................................................................................... 1 3.3 稳定状态................................................................................................................................ 1 3.4 温度偏差................................................................................................................................ 2 3.5 温度均匀度............................................................................................................................ 2 3.6 温度波动度............................................................................................................................ 2 3.7 相对湿度偏差........................................................................................................................ 2 3.8 相对湿度均匀度.................................................................................................................... 2 3.9 相对湿度波动度.................................................................................................................... 2 4 概述........................................................................................................................................... 2 5 计量特性................................................................................................................................... 2 6 校准条件................................................................................................................................... 3 6.1 环境条件................................................................................................................................ 3 6.2 负载条件................................................................................................................................ 3 6.3 主要标准器及其他设备........................................................................................................ 3 7 校准项目和校准方法............................................................................................................... 4 7.1 校准项目................................................................................................................................ 4 7.2 校准方法................................................................................................................................ 4 7.3 数据处理................................................................................................................................ 6 8 校准结果表达........................................................................................................................... 9 9 复校时间间隔........................................................................................................................... 9 附录 A 环氧乙烷灭菌设备校准记录参考格式........................................................................10 附录 B 环氧乙烷灭菌设备校准证书内页参考格式................................................................13 附录 C 环氧乙烷灭菌设备温度、相对湿度上偏差测量不确定度评定示例........................14
JJF（冀）199-2021
环氧乙烷灭菌设备温度、湿度参数校准规范
Calibration Specification for Temperature and Humidity Parameters ofEthylene Oxide Sterilization Equipment
2021-12-01实施
2021-09-16发布 目录 引言...............................................................................................................................................1 1 范围........................................................................................................................................... 1 2 引用文件................................................................................................................................... 1 3 术语和定义............................................................................................................................... 1 3.1 环氧乙烷灭菌设备................................................................................................................ 1 3.2 标称值.................................................................................................................................... 1 3.3 稳定状态................................................................................................................................ 1 3.4 温度偏差................................................................................................................................ 2 3.5 温度均匀度............................................................................................................................ 2 3.6 温度波动度............................................................................................................................ 2 3.7 相对湿度偏差........................................................................................................................ 2 3.8 相对湿度均匀度.................................................................................................................... 2 3.9 相对湿度波动度.................................................................................................................... 2 4 概述........................................................................................................................................... 2 5 计量特性................................................................................................................................... 2 6 校准条件................................................................................................................................... 3 6.1 环境条件................................................................................................................................ 3 6.2 负载条件................................................................................................................................ 3 6.3 主要标准器及其他设备........................................................................................................ 3 7 校准项目和校准方法............................................................................................................... 4 7.1 校准项目................................................................................................................................ 4 7.2 校准方法................................................................................................................................ 4 7.3 数据处理................................................................................................................................ 6 8 校准结果表达........................................................................................................................... 9 9 复校时间间隔........................................................................................................................... 9 附录 A 环氧乙烷灭菌设备校准记录参考格式........................................................................10 附录 B 环氧乙烷灭菌设备校准证书内页参考格式................................................................13 附录 C 环氧乙烷灭菌设备温度、相对湿度上偏差测量不确定度评定示例........................14
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