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PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The recommended (and validated) sterilization cycle parameters for all models (Sterilization Pouches (FP) and Rolls(FL) with Chemical Indicator) are: - For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes. Validated minimum dry time is 20 minutes. - For EO sterilization; 100%ethylene oxide(EO) with a concentration of 725mg/l at 55 degrees C and 50o 80%relative humidity for 60 minutes. Aeration time is 8 hours. Chemical process indicators on the exterior of the pouch and roll indicate by color change that the pouch has undergone either a steam or ethylene oxide sterilization process. Type1 steam indicator will change color from pink to brown after exposure to pre-vacuum steam sterilization process. Type 1 ethylene oxide indicator will change from turquoise to ethylene oxide sterilization process. As Worst Case Validated Load; general medical devices with stainless steel lumens with the following internal diameter (ID) and Maximum Lumen Lumen length can be processed in the validated steam and ETO sterilization cvcles as follows: Table 1.Worst Case Validated Load and Lumen Claims. | Pouch Size | Product<br>Code | Max.Load<br>Weight (Ibs.) | Max. lumen length<br>(mm) | Min. internal<br>diameter (mm) | Max # Lumens | |--------------|-----------------|---------------------------|---------------------------|--------------------------------|--------------| | 50 x 200 mm | FP 0520 | 0.062 | 50.8 mm | 1.5 mm | 1 | | 200 x 300 mm | FP 2030 | 0.516 | 200 mm | 3.0 mm | 1 | | 250 x 300 mm | FP 2530 | 0.520 | 200 mm | 3.0 mm | 1 | | 500 x 600 mm | FP 5060 | 3.344 | 400 mm | 3.0 mm | 1 |

PMSSteripack Flat Sterilization pouches (FP) and rolls (FL) with Chemical Indicator; are manufactured from medical grade paper/ laminated PET/PP film, by heat sealing on sides. Triple band seal provides three independent barriers to contamination, while reducing the risk of fiber tear. PMSSteripack Flat Sterilization Pouches (FP) and Rolls (FL) with Chemical Indicator; are divided into 2 main groups as below; - Sterilization Pouches, Flat: These pouches are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the remaining open side is heat sealed by the end user. - Sterilization Rolls, Flat: These rolls are manufactured from medical grade paper/plastic film that is heat sealed on opposite two sides. The required size is cut from the roll and the remaining open sides are heat sealed by the end user. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. After the sterilization process is completed, the sterility of the enclosed medical device is rnaintained for 30 days.