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i ! <br /> EO Gas Sterilization Report <br /> Description Lot# Quantity(cartons) Sterilization Date Reference# <br /> U needle 14U-302 94 2019.05.14 JRDE020190514 <br /> Process Parameters <br /> Item <br /> Unit of Measure Setting Tolerance Range <br /> Precondition temperature C 50 45-,-55 45^-55 <br /> Precondition humidity O/oRH 40 4070 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 MINIS / 0-4 3 <br /> Humidity injection pressure KPa / -60±5.0 -60.7 <br /> Humidity dwell MINS 30 30±2 30 <br /> EO injection pressure KPa / -30±5.0 -31.2 <br /> EO Weight(99.9%) Kg 15 15±0.5 15.0 <br /> Humidity ®/®RH / 40-70 42.8 .67.3 <br /> Exposure temperature °C 50 45^55 46.2 .52.7 <br /> Exposure time MINS 480 480500 480 <br /> EO concentration mg/L 600 580-620 600 <br /> Cleanings NUMBER 3 3 3 <br /> Evacuation KPa -60 -60±5 -61.2 <br /> Hold MINS 15 1520 15 <br /> Aeration time MINS 30 3045 30 <br /> Aeration temperature °C / / 1633 <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 IS013485:2016. <br /> And ETO Sterilization is comply with the applicable international standard of IS011135: 2014. <br /> 3080 YONGE STREET SUITE 3020,TORONTO CANADA M4N3N1 <br /> W.TfNADAVIES.0 OM 1.888.510.1388 <br />