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Sterilization certified in line with MPI M EDICOPLAST EN ISO 13485:2016/ EN ISO 11135:2014 Confirmation of Sterilization Method: VA S 1 Sterilization data: 2020.11-02 Sterilization lot 18564 Customer. MT,DERM GmbH Your requisition no,: 28102020 GB7=20-EB3163,GB22=20-EB3165,GB8=20-EB3215,GB13=20-EB3216 Our delivery note: 252863 from 2020-11-05 Item: 9900031 Sterilisation Pal. MP01 ld NK Pr.70 Quantity: 4 Pal. The physical parameters were in accordance to the spec cations. No growth was observed for the microbiological Inprocess control with biological ndicators (Bacillus atrophaeus, 3M Attest). / pe The sterilization was conducted in line with the customer validation parameter. /�W; kpproval oc ll1 r�992' Signature QS: Date: /(xj 52Te�C��"^ Nominal values Actual values Incomina time: min. 12 h 0 IN Preconditioning Dwell: min. 16 h 70 h Conditions: 35-45°C 50.80%rel.humidty 35-45°C 5080%rel.humidity Sterilization Cycle: MPI Temperature: 40 t3 °C 40 °C Prevacuum: 120 t10 mbar abs 125 mbar abs Humidity: 50-80%rel.humidily 68,8% rel.humidity Dwell time: 3 h 3 h EO mass: 16.32 kg 26 kg Air washes: min. 3 3 eration Dwell: min. 1 Days 2,5 Days Condition: 3545 eC 36450C Remarks: No incoming time needed, because incoming was before November. The evaluation from the Bl's is In process. The physical parameters were in accordance to the spec cations. No growth was observed for the microbiological Inprocess control with biological ndicators (Bacillus atrophaeus, 3M Attest). / pe The sterilization was conducted in line with the customer validation parameter. /�W; kpproval oc ll1 r�992' Signature QS: Date: /(xj 52Te�C��"^