13.8 Check for function
❯
After the end of the cleaning and disinfection
cycle, check the components for any residual
soiling and moisture. If necessary, repeat the
cycle.
❯
Check the components for damage and
replace if necessary.
❯
The parts should be packaged as soon as
possible after drying and checking.
13.9 Packing
WARNING
Endangering the sterilisation success
The fitted components are not reached
by the steam and as such are not steri-
lised.
❯
Do not fit the components before
packaging.
For packaging of the components, use only ster-
ile barrier systems made of transparent paper film
that are approved for use in steam sterilisation
according to the manufacturer information. This
includes:
– Temperature resistance up to 138°C
– Standards ISO 11607-1/2
– Applicable parts of the series of standards
EN 868
The sterile barrier system must be large enough.
Once it is loaded, the sterile barrier system must
not be under any strain.
13.10 Steam sterilising
WARNING
Health risk due to incorrect sterilisa-
tion
If the sterilisation not performed cor-
rectly, it may not be effective. The use of
instruments that have not been properly
sterilised can pose a health risk to the
patient..
❯
Only steam sterilisation must be used.
❯
Comply with all of the specified proc-
ess parameters.
❯
Comply with the manufacturer‘s
instructions regarding use of the steam
steriliser.
❯
Do not use any other methods.
NOTICE
Damage to equipment due to incor-
rect sterilisation
If the sterilisation process is not per-
formed correctly, this can cause dam-
age to the product.
❯
Comply with the manufacturer‘s
instructions regarding use of the steam
steriliser.
❯
Comply with all of the specified proc-
ess parameters.
Requirements placed on the steam steriliser:
– Corresponds to EN 13060 or EN 285 and/or
ANSI AAMI ST79
– Suitable programme for the products listed
(e. g. with hollow bodies, fractionated vacuum
procedure in three vacuum steps)
– Sufficient product drying
– Validated process in accordance with ISO
17665 (valid IQ/OQ and product-specific per-
formance appraisal (PQ))
Perform the following steps:
❯
Sterilise the parts for sterilisation(at least 20
minutes at 121°C, at least 4 minutes at 270°F
or at least 5 minutes at 134°C).
Do not exceed 138°C.
Marking
❯
Mark the packaged, treated medical product in
such a way as to ensure safe application.
Usage
9000-615-32/02 2012V003 41
EN
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