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tina davits <br /> EO Gas Sterilization Report <br /> Description Lot# Quantity(cartons) Sterilization Date Reference# <br /> 14 curved 14C-305 134 2020.11.16 JRDE020201116 <br /> Process Parameters <br /> Item <br /> Unit of Measure Setting Tolerance Range <br /> Precondition temperature V 50 45-55 45-55 <br /> Precondition humidity %RH 40 40-70 40-65 <br /> Precondition hold MINS 480 360-720 480 <br /> Interval time MINS / <40 20 <br /> Initial evacuation KPa -60 -60t5.0 -62.1 <br /> Humidity injection time MINS / 0-4 3 <br /> Humidity injection pressure KPa / -60t5.0 -60.4 <br /> Humidity dwell MINS 30 30±2 30 <br /> EO injection pressure KPa / -30t5.0 -30.2 <br /> EO Weight(99.9%) Kg 15 15t0.5 15.0 <br /> Humidity %RH / 40^-70 43.1-64.6 <br /> Exposure temperature V 50 45-55 46.5-53.5 <br /> Exposure time MINS 480 490-500 480 <br /> EO concentration mg/L 600 580-620 600 <br /> Cleanings NUMBER 3 3 3 <br /> Evacuation KPa -60 -60±5 -60.3 <br /> Hold MINS 15 15-20 15 <br /> Aeration time NIINS 30 30^-45 30 <br /> Aeration temperature "C / / 6^-23 <br /> Aeration time Days 7 7-8 7 <br /> We hereby certify that the above mentioned goods were produced according to quality management system <br /> of ISO13485:2016. <br /> And ETO Sterilization is comply with the applicable international standard of ISO11135: 2014. <br /> ! <br /> ISO <br /> 13405:2010 <br /> 3080 YONGE STREET SUITE 3020,TORONTO CANADA M4N3N1 <br /> WWW.TINADAVIES.COM 1.888.510.1388 <br />