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Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: - Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time . - Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time . - . Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time - . Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time - . Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F). The device is not intended and has not been validated for sterilization of devices that contain lumens. The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide. The Tyvek version of the pouch is for EO sterilization only. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 4). The subject device is intended and has been validated to maintain sterlity of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization. The maximum validated pouch load is 2.64 pounds (1.2kg).

The Safe Secure Sterilization Pouches are made from either a medical grade porous paper or Tyvek thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open in order to receive the medical device to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size. The base model numbers for the subject device are described as follows, where the last three letters corresponds to the type of material: - ABSST - Self seal Tyvek - ABHST Heat seal Tyvek . - ABHSP Heat seal paper ● - ABSSP Self seal paper . The pouches also contain external chemical indicators used to indicate that the pouches have been processed by either a steam or ethylene oxide sterilization process. The medical grade paper versions can be used in either gravity steam, pre-vacuum steam, or ethylene oxide (EO) sterilization cycles. The Tyvek version is only for EO sterilization.

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C (250 °F). The recommended EtO gas sterilization cycle is 735mg/L of ethylene oxide (EtO) for 1 hour at 55℃ (130 ° F) and 50% to 80%RH. The pouch's external chemical ink indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=109) of the enclosed device until used.

These pouches are manufactured from a medical grade paper and plastic film that is aged to are heat sealed on three sides. The fourth side has an addesive tape that is wed to seal the pouch or heat-seated by the heat-seel machine. The modical brade pager conforms to recognized material standards and can be steellized by steam or conforms fo recognized material starkers childreators has the same intended use, Essential Component, Raw material, Sterillzator method, manufacturing mellods and same technological characteristics as these predical testing of Substantial equivalent to the predicate device was established by physical testing of the medical grade paper (pressure drop vs. five and fifthelion officiency) and tilln (thickness, tensile strength and elongation) from non-stermanner of these linished ellygene oxice sterlilzed linished devices, as well as, performance diatribution for devices (seal strength, package burst, dye migralian cride sterfitzalion for steam and ethytene oxide sterlilzabions, ataam and ethylene oxide storibalion of shoum and einytene balde bennizators meet the performance requirements of ANSI/AAMMSO 11140-1:2005 standard entitled "Sterlizztion of health caro products-ANOMANICAL indications- Part 1: General requirements". The pouches are manufactured from modical grade paper that is the fourth side an to laminated film on the left, right, and bottom of pouch. The fourth side has an edhealve tape that is used to that is used to see to see to section dealers. The pouches heat-seal machine prior to sterlization of the enclosed medical devices were processed contain extennal chemical indicators used to indicato the pouches were processed to via steam or EIO sterilization. See Chatper 10 for a detailed device description via steam or ENO sterility achievement and compatibility with stearn and EIO starilization processes and Bill of Materialis.