Issue Clearance For The Parts For; Sterilization; 10 Storing Parts For Sterilization - Air Techniques ProVecta 3D Prime Instrucciones De Uso

Steam sterilization
WARNING
Incorrect sterilization reduces ef-
fectiveness and can damage the
product
Only steam sterilization is permitted� i
Comply with the specified process
i
parameters�
Comply with the manufacturer's in-
i
structions regarding use of the steam
sterilizer�
Do not use any other methods�
i
Steam sterilizer requirements:
– Complies with EN 13060 or EN 285 and/or
ANSI AAMI ST79
– Suitable programs for the products listed
(e� g� with hollow bodies: fractionated vacuum
procedure including three vacuum steps)
– Sufficient drying of the product
– Validated processes in accordance with DIN
EN ISO 17665 (valid IQ/OQ and product-
specific performance appraisal (PQ)
Perform the following steps:
Sterilize the parts for sterilization (at least 20
i
minutes at 250°F, at least 4 minutes at 270°F
or at least 5 minutes at 274°F)�
Do not exceed 281 °F�
Marking
Mark the packaged, treated medical device
i
appropriately such as to ensure its safe appli-
cation�

9.9 Issue clearance for the parts for

sterilization

The reprocessing of the medical device ends
with the documented clearance for storage and
renewed use�
Document the release of the medical device
i
after reprocessing�
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9.10 Storing parts for sterilization

Comply with the stated storage conditions:
i
– Store the parts protected against contami-
nation
– Dust-protected, e�g� in a locked cabinet
– Protected against moisture
– Protected against excessive temperature
fluctuations
– Protected against damage
The integrity of the packaging of a sterile
medical device be lost as a result of a partic-
ular incident and the passage of time�
Potential external contamination of the sterile
barrier system should be taken into account
in terms of aseptic preparation when estab-
lishing the storage conditions�
Usage
EN
US
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