Description Overview Ethylene oxide sterilizer designed for 8 pallets Pallet size: 1200 x 1423 mm (larger than standard size of 1200 x 1000 mm) If the chamber internal size is 12 x 1.4 x 1.2 meters, it will need a 45-foot container to ship If the pallets are standard size 1000 x 1200 mm, a 40-foot standard container can be used Standards For Sterilizer Manufacturing And Validation ISO 13485-2016 medical device quality management system EN 1422-2014 ethylene oxide sterilization requirements and test methods 2006.95.EC low voltage directive 2006.42.EC machine directive 94.9.EC ATEX 95 equipment directive EN 1127-1:2019 explosive atmospheres, explosion prevention and protection YY 0503-2015 classification and requirements for ethylene oxide sterilizers ISO 11135-2014 EO development, validation and routine control of sterilization FDA 21 CFR part 11 electronic record and electronic signature SpecificationsVoltage: AC480V 3P 60HzTotal consumption kwh cycle: 414.9
