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ting, davies <br />EO Gas Sterilization Report <br />Description <br />Lot # <br />I Quantity (cartons) <br />Sterilization Date <br />Reference # <br />Precision PMU Needle Cartridges <br />072021 <br />154CTNS <br />2021,7.14 <br />PO# 291 <br />Process Parameters <br />Item <br />�Ye hereby certify that the above mentioned goods have been sterilized by <br />Unit of Measure <br />Setting <br />Tolerance <br />Range <br />Precondition temperature <br />°C <br />52 <br />45^55 <br />45^55 <br />Precondition humidity <br />%RHDFDF <br />61 <br />40^•70 <br />53 66 <br />Precondition hold <br />MINS <br />480 <br />360720 <br />480 <br />Interval time <br />MINS <br />/ <br /><40 <br />30 <br />Initial evacuation <br />KPa <br />=60 <br />=60±5.0 <br />-60.4 <br />Humidity injection time <br />MINS <br />/ <br />0�4 <br />2 <br />Humidity injection pressure <br />KPa <br />/ <br />-60±5.0 <br />-60.9 <br />Humidity dwell <br />MINS <br />30 <br />30±2 <br />30 <br />EO injection pressure <br />KPa <br />/ <br />-30±5.0 <br />-28.8 <br />EO Weight (99.9°/x) <br />Kg <br />15 <br />15±0.5 <br />15.2 <br />Humidity <br />%RH <br />/ <br />40^70 <br />53.168.8 <br />Exposure temperature <br />°C <br />50 <br />45-55 <br />48.7.53.5 <br />Exposure time <br />MINS <br />480 <br />480^500 <br />483 <br />EO concentration <br />mg/L <br />600 <br />580^•620 <br />610 <br />Cleanings <br />NUMBER <br />3 <br />3 <br />3 <br />Evacuation <br />KPa <br />-60 <br />-60±5 <br />-57.7 <br />Hold <br />MINS <br />15 <br />15^•20 <br />18 <br />Aeration time <br />MINS <br />30 <br />3045 <br />40 <br />Aeration temperature <br />°C <br />5^ 15 <br />Aeration time <br />Days <br />7 <br />7�8 <br />7 <br />EO Gas according to the regulation of ISO 13485:2016 <br />3080 YONGE STREET SUITE 30201 TORONTO CANADA iV14N3N 1 <br />WWW.TINADAVIES.COM 1.888.510.1388 <br />