13.9 Packing
CAUTION
Endangering the sterilisation success
The fitted components are not reached
by the steam and as such are not ster-
ilised.
❯
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 DIN EN ISO 11607-1/2
– The applicable sections of the standard series
DIN 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 pro-
cess 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 pro-
cess 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 DIN EN
ISO 17665 (valid IQ/OQ and product-specific
performance appraisal (PQ)
Perform the following steps:
❯
Sterilise the parts for sterilisation (at least 20
minutes at 121°C, at least 4 minutes at 132°C
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.
13.11 Issue clearance for the parts
for sterilisation
The reprocessing of the medical products ends
with the documented clearance for storage and
renewed use.
❯
Document the clearance of the medical prod-
uct after reprocessing.
Usage
54 9000-615-28L02 1903V004
EN
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