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3H ETO STERILIZATION SUMMARY REPORT START TIME:05/01/2016 EO STERILIZATION REPORT PATCH NO: L10601205 'EVERLASTING( ITEM NAME: Everlasting Brows Microblading Blades OVER TIME: 15/01/2016 BROWS RE-VALIDATION: 15/01/2019 In Temperature in the chamber from a minimum of two locations throughout the Not used sterilization cycle;ifused Temperature Min C. N/A N/A N/A Precondition Temperature and humidity within the preconditioning area(if used),monitored Temperature C. 50 45 54 Range requested parameter and recorded from a specified position; Humidity %RH 55 30 65 Range requested Time of commencement and of removal of load from preconditioning(if used)of each sterilization load; Preconditioning Time Mins 180 120 300 Range requested Elapsed time between removal of the sterilization load from preconditioning(if Transfer Time used)and the commencement of the sterilization cycle; Transfer Time Mins N/A N/A N/A Not used Indication of the satisfactory operation of the chamber gas circulation system Initial Gas Injection Kpa -38 N/A Information to be (if used)during gas exposure; -40 completed by supplier End Gas Injection 50 40 65 -Exposure Temperature C. 50 45 54 Temperature and pressure in the chamber throughout the sterilization cycle -Flushing Pressure:. kPa 50 40 65 parameters required -Vacuum Pressure -10 -10 -6 in the certificate of Sterilization sterilization to be Chamber humidity during conditioning by pressure and/or direct monitoring Exposure Humidity %RH 30-85 29.7 93.5 send to AMD-Ritmed Range for release of sterile ((Requested Parameters for release Evidence that the gaseous ethylene oxide has been admitted to the sterilizer Total Injection Gas product of Sterile Medical chamber; Weight Kg 50 Device as per ISO Standard)) Pressure rise and the quantity of ethylene oxide used or the concentration of `ethylene oxide in the sterilizer chamber ETO concentrationmg/1 : 520 520 Conditioning time Exposure Time Mins 480 480 480- Time,temperature,pressure changes(if any)and/or the operation of the air Air Wash Time 30 15 30 No comment supply(if used)during aeration. Mins Aeration Time 3 Information to be completed by supplier biological If biological indicators are used in routine monitoring,they shall comply with 8.6. NOTE 1 See also 8.7. N/A N/A N/A N/A N/A Not used indicators If chemical indicators are used in routine monitoring,they shall comply with 8.8.