Bowa Argon - Page 24

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22 BOWA-IFU-MN030-978-S11-ARGON-ML-20230221
5.4 Packaging
Before sterilization the disassembled instruments habe to be packaged in a
suitable disposable sterilization packaging (single or double packing) and / or
suitable sterilization containers:
• in accordance with DIN EN 868/ANSI AAMI ISO 11607
• suitable for steam sterilization (temperature resistance up to 137 ° C,
sufficient steam permeability)
• regularly maintained (sterilization container)
Sterilization in the transport packaging is not allowed!
5.5 Autoclaving
For sterilisation, be sure to disconnect the HF cable from the flexible argon probe.
Only the sterilization procedure listed below should be used for sterilization;
other sterilization procedures are not permitted.
Steam sterilization:
• Fractionated vacuum process
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(with adequate product drying)
• Steam sterilizer in accordance with DIN EN 13060 or DIN EN 285
• Validated in accordance with DIN EN 554/ ANSI AAMI ISO 11134 (valid
commissioning and productspecific performance assessment)
• Maximum sterilization temperature 134 - 137°C (plus tolerance according to
DIN EN 554/ANSI AAMI ISO 11134)
• Sterilization time at least 20 min (at 121°C) or 3 to 20 min at 132/134°C
The suitability of the products for effective sterilization has been proved by the
manufacturer using the fractionated vacuum method with the above
sterilization times/temperatures. The basic suitability of the products for
effective steam sterilization has been proved by means of an independent
accredited test laboratory using the fractionated vacuum method
(EuroSelectomat from the company MMM Münchener Medizin Mechanik
GmbH, Planegg). The method described above was taken into account here.
The hot air sterilization method is generally not permitted (damage to
products).
The use of other sterilization methods (e.g. ethylene oxide, formaldehyde,
radiation and low-temperature plasma sterilization) is outside the
manufacturer‘s responsibility. In this case, the respectively applicable
standards must be taken into account
(DIN EN ISO 14937/ANSI AAMI ISO 14937 and process-specific standards), and
evidence must be provided of the suitability and effectiveness in principle of the
process (including tests of residuals of the sterilization medium if necessary)
taking into account the specific product geometry as part of the validation.
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The use of the less effective gravitation method must be safeguarded by additional
validation (longer sterilization times may be necessary).