•Maintained on a regular basis.
If double, single-use sterilization packaging (double bag) is
to be used, this must also comply with EN ISO 11607 and
be suitable for steam sterilization (temperature resistant to
138°C with adequate steam permeability).
Use only the following listed steam sterilization procedures
for sterilization; other sterilization procedures are not
permissible:
•Fractional pre-vacuum procedure (steam sterilization with
repetitive pre-vacuum.)
•Steam sterilizer in accordance with EN 13060 or EN 285
validated in compliance with EN IS0 17665,
•Maximum sterilization temperature 138°C,
•Sterilization time at least 3 min. at 134°C (fractional pre-
vacuum procedure),
•Sterilization at 134°C for a maximum of 20 minutes is
permissible.
The hot-air sterilization and radio-sterilization
procedure may not be used (as it causes the
destruction of products).
The manufacturer assumes no responsibility
for the use of other sterilization procedures (E.g.
ethylene oxide, formaldehyde and low temperature
plasma sterilization). In such cases, please observe the
respective valid standards (EN IS0 14937/ANSI AAMl
IS0 14937 or the procedure-specific standard) and
verify the suitability and effectiveness in principle of
the procedure (if necessary, including investigations
on sterilizing agent residue), taking into account the
specific product geometry as part of the validation.
9. SERVICE LIFE
The products have been designed for a large number of
sterilization cycles. The materials used in their manufacture
were selected accordingly. However with every renewed
preparation for use, thermal and chemical stresses will
result in aging of the products.
If the number of permissible re-sterilization cycles is
restricted, this will be pointed out in the product specific
instructions.
The use of ultrasound baths and strong cleaning and
disinfection fluids (alkaling pH>9 or acid pH<5) can reduce
the life span of products. The manufacturer accepts no
liability in such cases.
The products may not be exposed to temperatures above
138°C.
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