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r � w� <br /> Sterilization certified in line with <br /> �M MEDICOPLAST <br /> DIN EN ISO 13485:20121 EN ISO 11135-1:2014 <br /> I <br /> Confirmation of Sterilization <br /> Method:VA 7-5-1-6 <br /> Sterilization date: 2019-02-05 <br /> Sterilization lot: 17271 <br /> Customer. MT.Derm GmbH <br /> I <br /> YoLr delivery note: 19-EB0398,19-EB0466, <br /> Your requisition no.: 19-EB0476,19-EB0478,19-EB0482,19-EB0488, <br /> 19-EB0490,19-EB0491,19-EB0495 <br /> Our delivery note: 243927 from 2019-02-07 <br /> Item: 9900031 <br /> Sterilisation Pal. MP01 1 d NK <br /> Pr.70 <br /> Quantity: 9 Pal. <br /> Nominal values Actual values <br /> Incoming time: min. 12 h 100 h <br /> Preconditioning 29,5 h <br /> Dwell: min. 16 h <br /> Conditions: 35-45°C 50-80% rel.humidity 35-45°C 50-80%rel.humidity <br /> Sterilization <br /> Cycle: MP1 39°C <br /> Temperature: 40±3°C <br /> Prevacuum: 120±10 mbar abs 123 mbar abs <br /> Humidity: 50-80%rel.humidity 63,1%rel.humidity <br /> Dwell time: 3 h 3 h <br /> EO concentration (calc.): 1.000±50 mg11 1.000 mg/I <br /> Air washes: min. 3 3 <br /> Aeration 1 Days <br /> Dwell: min. 1 Days 36-46 <br /> °C <br /> Condition: 35-45°C <br /> Remarks: The evaluation from the BI's is in process. <br /> The physical parameters were in accordance to the 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 /> Approval <br /> /� xx <br /> Signature QS: Date: <br />