Sterilization
Moist heat sterilize as per ISO/TS 17665 Part 1 and Part 2.
1. Prepare NLR for sterilization.
2. Pack NLR in the sterilization pouch or place it in a
tray and ensure that steam can penetrate through
all surfaces.
3. Run sterilization cycles in pre-vacuum mode with
either of the paremeters described in Table 2.
Table 2: Moist heat sterilization parameters
Process steps
Parameters
Method
Moist heat sterilization
Pre-vacuum phases
Temperature
132°C (270°F)
Exposure time
4 minutes
Drying time
30 minutes
Packaging
Carefully examine the sterile instrument packaging prior
to use, ensuring package integrity is maintained.
Do not use if package is opened or damaged. If so, repeat
the reprocessing steps.
The sterile barrier system should comply with ISO/TS
16775 and ISO 11607 Part 1 and 2.
Storage
Store in a dark, dry, cool place. Avoid extended exposure
to light.
The instructions provided above have been identified
by the manufacturer of the medical device as being
CAPABLE of preparing a medical device for re-use. It
remains the responsibility of the processor to ensure
that the reprocessing as actually performed using
equipment, materials and personnel in the reprocessing
facility achieve the desired result. This normally requires
validation and routine monitoring of the process.
The Bookwalter is a Specialty Surgical Instrumentation
Inc. product.
The Iron Intern is an Automated Medical Products Corp.
Product.
The Cidezyme Xtra Multienzyme is an Advanced
Sterilisation Products product.
3
134°C (273°F)
3 minutes
5