YY/T 1302.1-2015 Translated English of Chinese Standard. YY/T1302.1-2015: Physical requirements and microbiological performance of ethylene oxide sterilization - Part 1: Physical aspectsThis part of YY/T 1302 specifies the physical requirements for the sterilization of ethylene oxide. This part is intended to provide guidance for sterilization equipment, preconditioning, calculation of relative humidity, concentration of ethylene oxide, flammability, statistical applications in process equivalents. |
Contents
Calculation of ethylene oxide concentration | 17 |
Calculation by the use of flammability curves | 19 |
Guide to statistical contrast methods for determining process equivalence | 20 |
Appendix A Informative An example of a method for determining the concentration of ethylene oxide gas based on the physical formula of an ideal ... | 26 |
Appendix B Informative Calculation example using a flammability curve | 29 |
Common terms and phrases
absolute humidity absolute pressure and/or average concentration bilateral analysis calculated calibration cleaning process common ethylene comply concentration of ethylene confidence level continuous steam injection dew point diluent dynamic processing electromagnetic interference entering the preconditioning equipment problem ethylene oxide gas ethylene oxide sterilization evaluate example exposure flammability curve formula gas as injected gas components Guangzhou heat distribution humidity level ideal gas equation inert gas limit of summary loading temperature mass fraction mass of ethylene maximum moisture molar mass normal distribution normal test operating temperature oxide and 80 oxide as injected oxide sterilization process parameter partial pressure pass the normal ppk or Cp ppk value Preconditioning area preconditioning zone processing stage product loading pulsed steam injection relative humidity room/zone/cabinet sensors static humidification statistical steam injection pressure sterilant mixture sterilization cycle sterilization loads sterilizing cabinet sterilizing gas storage summary worksheet temperature control upgrade validation volume fraction water vapor pressure