Packaging; Sterilization; Overview Of Validated Procedures - Erbe 20190-045 Manual Del Usuario

OBJ_DOKU-180148-009.fm Seite 31 Donnerstag, 17. Januar 2019 10:12 10
7.9

Packaging

1. Pack the product in disposable sterilization packaging (single
or double packaging) made from paper/foil and/or in a ster-
ilization container.

7.10 Sterilization

Only sterilize products that have been cleaned and disinfected.
Erbe Elektromedizin recommends steam sterilization with the
method described below. If other sterilization methods are used,
Erbe Elektromedizin shall bear no responsibility.
Steam sterilization
• Fractionated vacuum method with adequate product drying
• Holding time 3 to 18 minutes at 132 to 138 °C
• Sterilizers in accordance with applicable national standards
and regulations (e.g. DIN EN 13060 or DIN EN 285)
• Sterilization process validated according to DIN EN
ISO 17665
Please follow the recommendations issued by the sterilizer man-
ufacturer concerning loading, handling, and drying times.

7.11 Overview of validated procedures

The following procedures have been validated as suitable for
processing the product:
• Manual cleaning/disinfection with the detergent Cidezyme
and disinfectant Cidex OPA (Johnson & Johnson Medical
Limited, Gargrave, Skipton).
– Cidezyme: Dosage 1.6%, 5 minutes exposure time at
room temperature.
– Cidex OPA: Dosage 0.3%, 12 minutes exposure time at
20 °C.
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