
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