Sterilization Method And Parameters; Sterilization For The Us Market; Storage - B.Braun Acculan 3Ti Manual De Instrucciones

9.9 Sterilization method and
parameters
Note
The product may only be sterilized with all tools etc.
unmounted.
Make certain that all external and internal surfaces
of the product will be exposed to the sterilizing
agent.
Validated sterilization process
– Disassemble the product
– Steam sterilization through fractionated vacuum
process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization through fractionated vacuum process
at 134 °C/2 bar; holding time 5 min.
When sterilizing several products at the same time
in one steam sterilizer: Make certain that the
maximum allowable load capacity of the steam
sterilizer, as specified by the manufacturer, is not
exceeded.

9.10 Sterilization for the US market

• Aesculap does not recommend the device sterilized
by flash or chemical sterilization.
• Sterilization may be accomplished by steam auto-
clave in a standard prevacuum cycle.
To achieve a sterility assurance level of 10
recommends the following parameters:
Aesculap Orga Tray/Sterilcontainer (perforated
bottom)
Minimum cycle parameters*
Sterilization Temp.
method
Pre-vacuum 270 °F—
275 °F
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accom-
plished in an Aesculap Sterilcontainer cleared by FDA
for the sterilization and storage of these instruments.
Other sterilization cycles may also be suitable, how-
ever individuals or hospitals not using the recom-
mended method are advised to validate any alternative
method using appropriate laboratory techniques. Use
an FDA cleared accessory to maintain sterility after
processing, such as a wrap, pouch, etc.

9.11 Storage

Store sterile products in germ-proof packaging
under dust protection in a dry, dark and
temperature-controlled room.
-6
, Aesculap
Time Minimum
drying time
4 min 20 min
21