Neutral Steam Sterilization - Brainlab RT/RS Hardware User's Manual

CLEANING, DISINFECTION, AND STERILIZATION
7.1.2

Neutral Steam Sterilization

Applicable Technology
Only use the following sterilization procedure, which has been validated in accordance with ISO
17665 and AAMI TIR 12-2004:
• Prevac/fractionated vacuum procedure with at least three vacuum phases
The use of other sterilization procedures may require longer sterilization times and must be
validated. This is the responsibility of the user.
Fractionated Vacuum Procedures
Procedure 1
Procedure 2
Procedure 3 (UK Only)
Validation Parameters
The fundamental suitability of the instruments for an effective steam sterilization was validated by
an independent test laboratory using the following parameters:
Sterilizer
Program
Sterilization Temp.
Sterilization Time
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware
Minimum Sterilization Time
20 min.
at least 4 min.
at least 3 min.
Euro-Selectomat 666, Münchner Medizin Mechanik, Planegg
Fractionated vacuum procedure
121°C
20 minutes
Minimum Sterilization Tempera-
ture
121°C (max. 124°C) (270°F, max
255°F)
132°C - 135°C (270°F - 275°F)
134 - 137°C (273 - 279°F)
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