medical sterilization reels

EN 868 ISO 9001:2000 CE certification

[Product Name]

Sterilization Reels With Chemical Indicator

[Properties]

Sterilization reels with chemical indicator is produced by hot-pressing of polypropylene and polyester multilayer films and used as a kind of disposable package material for final sterilized medical products. It identifies the sterilization process by the color changes of indication ink. During high-pressure steam sterilization, the pink color of indication ink becomes dark brown; during ethyleneoxide sterilization, the blue color of indication ink becomes yellow. However, this kind of indicator belongs to the indicator category defined in ISO11140-1995 (GB18282-2000) and can not be used for inspecting sterilization efficacy.

[Applicable Scope]

This product is suitable for packing reused medical instruments to be treated by high-pressure steam sterilization and ethyleneoxide sterilization.

[Intended Use]

1. Put the clean and dry instruments into the package bag (the instrument for sterilization shall not be longer than 3/4 length of the sterilization bag to ensure sufficient sealing, or, that may increase the risk of blowing up)

2.The sharp instrument shall be placed in the counter direction of peeling direction (ensure safe peeling).

3.Seal the bag with heat-sealing machine at 220°C to 260°C (the operation temperature is proportional to the machine speed).

4. According the requirement, the paper-plastic bags are placed into the stream sterilization device or ethyleneoxide sterilization device and sterilized routinely.

5. Confirm the color changes during the sterilization process: pink color before sterilization becomes dark after sterilization for stream sterilization and blue color becomes yellow for ethyleneoxide sterilization.

6. Place the aseptic sterilization bag onto dry, dark and clean location for storage and utilization.

7. When using, just strip the sterilization indication bag along the indicating direction and take the instruments out of the bag.

8. The move, transportation and storage of the packaged sterile products shall comply with the hygienic standard.

9. After routine sterilization, the products treated with steam sterilization and ethyleneoxide sterilization must be used within 6 mouths

[Notices]

1. This package bag is suitable for high-pressure steam sterilization or ethyleneoxide sterilization, but not for packing products need dry heat sterilization at above 140°C.

2. The used package bag shall be landfilled at prescribed place or incinerated at control.

3. This product shall not be used to indicate the sterilization efficacy. The indication ink is an indicator for sterilization process. The color changes are just used for confirming the sterilization process, not as aseptic indicator.

4. Storage method: it shall be kept at room temperature, 50% relative humidity and in dark place.

5. The shelf life of the package bag at room temperature is 2 years.

6. The duration of sterile storing after sterilization is 6 months. 

7. Please check the integrity of the sterilization indication bag before using; do not use it if damaged.

medical sterilization reels