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Sterilization certified in line with 1 Y I I M EDICOPLAST <br />EN ISO 13485:20161 EN ISO 11135:200 <br />Confirmation of Sterilization <br />Method: VAS 1 <br />Sterilization date: <br />2021-01-11 <br />sterilization lot: <br />18670 <br />Customer, <br />MT. DERM GmbH <br />Your delivery note: <br />06012021 <br />Your requisition no.: <br />GB23=20-EB3784,GB15=20-EB3792 <br />G622=20 -E B3815,G B19=20 -€63816,G B5=20.E63817 <br />GB2=20-EB3822,GB1 B=21-ES0023,GB9=21-EB0024 <br />GB10=21-EB0025 <br />Our delivery note: 253731 from 2021-01-14 <br />Item; 9900031 <br />Sterilisation Pal. MP01 1d NK <br />Pr.70 <br />Quantity: 9 Pal. <br />Nominal values <br />Incomina time: min. 12 h <br />Preconditlonina <br />Dwell: min. 16 h <br />Conditlons. 35A5°C 50-80%rethurrddity <br />Sterilization <br />Cycle: <br />►ylpl <br />Temperature: <br />40:t3 °C <br />Prevacuum: <br />120,t10 mbar abs <br />Humidity, <br />50-80% rel. humidity <br />Dwell time: <br />3 h <br />EO mass: <br />16-32 kg <br />Air washes: <br />min. 3 <br />Aeration <br />Dwell: <br />Condition: <br />min. 1 Days <br />35.45 °c <br />Remarks: The evaluatlonfrom the BI'sls in process. <br />Actual values <br />31h <br />63,75 h <br />35-46°C 50-60°fo rel.hurtttdity <br />The physical parameters were in accordance tothe specifications. <br />No growth was observed for the microbiological inprocess control with biological <br />Indicators (Bacillus atrophaeus, 3M Attest). <br />The sterilization was conducted in line with the customer validation parameter. <br />rovat <br />Signature QS: Date: r14f� �1 <br />39 °C <br />122 mbar abs <br />66,7% rel.humidity <br />3h <br />25 kg <br />3 <br />2,6 Days <br />35�i6'C <br />