FB-618/AU – rev.E – ed.2019/08
For Endochuck file holder:
• Reinstall the small O-ring (gasket) first, and then gently screw the retention bolt without
tightening it.
For any Instrument having its CombiTorque:
• Reinstall the Instrument on the CombiTorque.
Any EMS part can be correctly packaged using the following validated procedure:
• Single or Double Pouches suitable for Pre-Vacuum Moist Heat Sterilization compliant with
ISO 11607-1, or EN 868 resistant to 138°C and having adequate steam permeability (e.g.
Wipak STERIKING flat rolls Type R43 and R44).
Sterilization
Sterilization must be performed immediately after cleaning-disinfection.
DO NOT exceed the maximum number of sterilization cycles allowed.
DO NOT exceed a sterilization temperature of 138°C and a holding time of 20 minutes.
DO NOT use hot-air sterilization and radio-sterilization procedures: they destroy the products.
Moist heat sterilization of parts shall be performed according to ISO 17665 and under consideration
of the respective country requirements.
The following validated Pre-vacuum Moist Heat (steam) process can be used with any EMS part
packaged in appropriate single or double pouches:
Parameters for the Pre-vacuum Moist Heat cycle:
• 3 pre-vacuum phases
• Sterilization temperature of 132°C
• Pressure of 3 bar (absolute pressure)
• Humidity of 100%
• Holding time of 3 minutes minimum (full cycle)
• Drying time of 20 minutes minimum
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