Perform the following steps:
Sterilize the parts for sterilization (at least 20
❯
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
❯
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
❯
after reprocessing.
9.10
Storing parts for sterilization
Comply with the stated storage conditions:
❯
– 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 medi-
cal device be lost as a result of a particular inci-
dent and the passage of time.
Potential external contamination of the sterile
barrier system should be taken into account in
terms of aseptic preparation when establishing
the storage conditions.
2210200496L41 1911V006
Usage
EN-
US
45