Sterisheet Sterilization Wrap

The Sterisheet Sterilization Wraps are single use non woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Critical process parameters for the cycle are summarized below in Table 1.

Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer

EO Amount Temperature Relative Humidity EO Exposure Time Total Cycle Time

17.6 g ± 5% 50°C ± 3°C 35-90% 3 hours 3.5 hours

The product code for the Sterisheet Sterilization Wraps is listed in Table 2.

Table 2. Product code for the Sterisheet Sterilization Wraps

Product Designation Sterisheet S88 Blue

Product Code 0129

Maximum loads of specific materials and devices that have been validated are listed in Table 3. All validated maximum loads were processed without additional devices in the sterilizer. Sterility was maintained for at least 3 month after processing in an EOGas 4 sterilizer.

Table 3. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer

Device Type Maximum Load Device Examples Required Aeration

Metal 24 lbs (11 kg) Surgical instruments, Metal instruments do not absorb EO;

delicate sharps, including those Follow pouch or wrap manufacturer’s

with hinges and mated surfaces instructions (Example: Tyvek® pouches and

Sterisheet® wrap require ≥ 6 hours at 50°C).

Plastic 7.0 lbs (3.2 kg) Reusable power cords, trocars 24 hours at 50°C;

Fabric 6.1 lbs (2.8 kg) Reusable cloth gowns, towels Follow manufacturer’s instructions

Single-lumen One (1) ≥ 2.0mm ID Gastrovideoscopes, gastrointestinal 12 hours at 50°C;

Endoscope(s) ≤ 1100mm length; videoscopes Follow manufacturer’s instructions

No additional devices

Four (4) ≥ 1.2 mm ID Bronchoscopes, bronchovideoscopes,

≤ 700 mm length; cystoscopes, ureteroscopes,

No additional devices choledocoscopes