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fina davies <br /> EO Gas Sterilization Report <br /> Description Lot 4 Quantity(cartons) Sterilization Date Reference 4 <br /> 14 curved 14C-301 37 2019.06.13 JRDE020190613 <br /> Process Parameters <br /> Item <br /> Unit of Measure Setting Tolerance Range <br /> Precondition temperature °C 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 -60±5,0 -61.8 <br /> Humidity injection time MINS ! 0-4 3 <br /> Humidity injection pressure KPa / -60±5.0 -61.2 <br /> Humidity dwell MINS 30 30±2 30 <br /> EO injection pressure KPa / -30±5.0 -30.1 <br /> EO Weight(99.9%) Kg 15 15±0.5 15.0 <br /> Humidity %RH / 40^-70 42.7-66.5 <br /> Exposure temperature °C 50 45^-55 46.9^-52.4 <br /> Exposure time MINS 480 480^-500 480 <br /> EO concentration mg/1. 600 580^-620 600 <br /> Clcanings NUMBER 3 3 3 <br /> Evacuation KPa -60 -60±5 -60.8 <br /> Hold MINS 15 15^-20 15 <br /> Aeration time MINS 30 30^45 30 <br /> Aeration temperature C / / 21-33 <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 IS011135. 2014. <br /> ISO <br /> ltby <br /> 13485:2018 <br /> 3080 YONGE STREET SUITE 3020,TORONTO CANADA M4N3N1 <br /> WWW.TINADAVIES.COM 1.888.510.1388 <br />