Sterilization; Overview Of Validated Procedures - Erbe 20416-032 Manual Del Usuario

OBJ_DOKU-181800-011.fm Seite 29 Dienstag, 16. März 2021 8:28 08
7.9

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.

7.10 Overview of validated procedures

The following procedures have been validated as suitable for
processing the product:
• Manual cleaning/disinfection with the detergent Cidezyme
LF/Enzol and disinfectant Cidex OPA (Johnson & Johnson
Medical Limited, Gargrave, Skipton).
– Cidezyme LF/Enzol: Dosage 3%, 5 minutes exposure
time at 40 °C.
– Cidex OPA: Dosage 0.3%, 5 minutes exposure time at
20 °C.
• Machine cleaning and disinfection in a G 7836 CD disinfector
(Miele & Cie. KG, Gütersloh, Germany) with the cleaning
agent neodisher mediclean forte (Dr. Weigert GmbH & Co.
KG, Hamburg, Germany).
– neodisher mediclean forte: Dosage 0.5%, 5 minutes ex-
posure time at 55 °C
– Disinfection: 5 minutes at 90 °C.
29