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The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles: Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal 273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic Air Removal IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C

The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014. It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.