8 Maintenance
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z Use only this recommended sterilization procedure.
z Control the efficiency (packaging integrity, no humidity, color change of
sterilization indicators, physicochemical integrators, digital records of
cycles parameters).
z
Waiting for cooling before touching.
Storage:
Storage of sterilized components in a dry, clean and dust free environment at
modest temperatures, refer to label and instructions for use.
z Sterility cannot be guaranteed if packaging is open, damaged or wet.
z Check the packaging before using it (packaging integrity, no humidity
and validity period).
Reprocessing validation study information:
The above-mentioned reprocessing process (cleaning, disinfection,
sterilization) has been successfully validated. Refer to test reports:
The instructions provided above have been validated by the manufacturer of
the medical device as being capable of preparing a medical device for reuse. It
remains the responsibility of the processor to ensure that the processing, as
actually performed using equipment, materials and personnel in the processing
facility, achieves the desired result. This requires verification and/or validation
and routine monitoring of the process. Likewise, any deviation by the
processor from the instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.
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