WORLD OF MEDICINE PP110 Mode D'emploi page 47

(288 °F) with sufficient steam permeability).
• Sufficient protection of the product or the sterilization packaging against me-
chanical damage (e.g., from the spikes).
9.5.2.8 Sterilization
Only a clean, dry and disinfected as well as correctly assembled product (see
chapter 9.5.2.5 "Subsequent Drying", chapter 9.5.2.6 "Reinstalling the Mem-
brane" and chapter 9.5.2.7 "Packaging") may be sterilized. Only the sterilization
procedures listed below are to be used for sterilization. Other sterilization meth-
ods are not permitted.
Steam Sterilization
• Fractionated vacuum process with at least three vacuum steps (with sufficient
product drying >20 minutes).
• Steam sterilizer according to EN 13060 and EN 285. ANSI AAMI ST79.
• Validated according to EN ISO 17665-1 (valid commissioning (installation/op-
erational qualification/IQ/OQ, and product-specific performance evaluation
(PQ).
• Maximum sterilization temperature 138 °C (280 °F; plus tolerance according to
EN ISO 17665-1).
• Sterilization time (exposure time at sterilization temperature) between 5 and
18 min (for prion deactivation) at 132 °C (270 °F)/134 °C (273 °F).
Use of the less effective gravitation procedure is allowed only in case of non-
availability of the fractionated vacuum procedure; requires significantly longer
sterilization times and must be validated specifically for the products, devices,
and parameters in sole responsibility of the user.
The actual required drying time depends on parameters, which are the sole re-
sponsibility of the user (loading configuration and density, sterilizer condition,
etc.) and must therefore be determined by the user. However, drying times
should never be less than 20 minutes.
CAUTION!
Drying time
The indicated drying time depends on several variables, including the following:
Altitude, humidity, type of packaging, preconditioning, size of chamber, mass of
load, and placement in chamber. Users must verify that the drying time set in
their autoclave results in dry surgical equipment when using the method of sat-
urated steam sterilization described here.
The flash sterilization process is generally not permitted.
Do not use hot air sterilization, radiation sterilization, formaldehyde or plasma
sterilization
Individual automated processing methods must be independently validated by
the operator.
Ethylene oxide sterilization is possible but not validated by the manufacturer
9.5.2.9 Storage
After sterilization, the products in the sterilization packaging must be stored dry
and dust-free.
9.5.2.10 Reusability
The products can be reused up to 20 times, provided they are undamaged and
uncontaminated, and used with due care; any further use or the use of damaged
and/or contaminated products is the responsibility of the user.
If disregarded, any liability is excluded.
Care and Maintenance
Other sterilization methods
en
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