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tiny davies <br /> EO Gas Sterilization Report <br /> Description Lot# Quantity(cartons) Sterilization Date Reference# <br /> PIXL Needle Cartridges 022023 60CTNS 2023.2.14 PO#572 <br /> Process Parameters <br /> Item <br /> Unit of Measure Setting Tolerance Range <br /> Precondition temperature C 48 45-55 46-49 <br /> Precondition humidity %RHDFDF 52 40-70 52-60 <br /> Precondition hold MINS 480 360-720 484 <br /> Interval time MINS / <40 36 <br /> Initial evacuation KPa -60 -60t5.0 -60.1 <br /> Humidity injection time MINS / 0-4 3 <br /> Humidity injection pressure KPa / -60f5.0 -62.9 <br /> Humidity dwell MINS 30 30±2 31 <br /> EO injection pressure KPa / -30t5.0 -32.8 <br /> EO Weight(99.9%) Kg 15 15f0.5 15.2 <br /> Humidity %RH / 40-70 49.9-63.2 <br /> Exposure temperature V 50 45-55 48.6-52.0 <br /> Exposure time MINS 480 480^-500 482 <br /> EO concentration mg/L 600 580-620 611 <br /> Cleanings NUMBER 3 3 3 <br /> Evacuation KPa -60 -60±5 -60.7 <br /> Hold MINS 15 15-20 17 <br /> Aeration time MINS 30 30^-45 42 <br /> Aeration temperature °C / / 5^-15 <br /> Aeration time Days 7 7^-8 7 <br /> We hereby certify that the above mentioned goods have been sterilized by EO Gas according to the regulation of ISO 13485:2016 <br /> ISO <br /> 13485:2016 <br /> 3080 YONGE STREET SUITE 3020,TORONTO CANADA M4N3N1 <br /> WWW.I'INADAVIES.COM 1.888.510,1388 <br />