General Description
Sterilization pouches are a packaging solution for sterilization applications, ensure the protection of the medical device against contamination with bacteria and chemicals from the time of sterilization until use of the sterile medical device. Wide range of standard sizes allows optimum choice of a correct-sized pack for each item.
Sterilization pouches are constructed from transparent PET/PP multi-layers and medical kraft paper. Process indicators for steam and ethylene oxide sterilization are applied on the paper surface of the reel and help to differentiate between processed and unprocessed packages.
All process indicators are water based and non-toxic inks and meet or exceed the requirements of ISO 11140-1 standard and provide accurate and clear color change after sterilization process.
Wide range of standard sizes allows optimum choice of a correct-sized pack for each item and for double packing purposes and as a requirement of EN ISO 11607; all processes used for sterilization pouch manufacturing process validation has been conducted.
Intended Use
Intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization, provided package integrity is maintained.
Please note that this device shall only be used by a well-trained and qualified healthcare person or under supervision of a physician in hospital or clinical settings.
Product Features