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2.2
Residual sterilizing risks
The VARIOKLAV Type 65 TC benchtop sterilizer ensures safe sterilization, when
used as directed and if the appropriate sterilizing program has been chosen for the
load to be sterilized. A complex error management system monitors the unit for
2)
technical problems
, indicates and documents them, and directs the user to the
correct reaction (troubleshooting, re-sterilization):
Even when all technical prerequisites for safe sterilizations exist, sterility of the load
cannot be guaranteed.
There is always a residual risk, depending in part on the care with which the user and
operator perform their respective tasks:
• Omission of the checks enumerated in the maintenance manual.
• Feed water impurities.
• Using tap water with a high chloride concentration instead of deionized
water
• Insufficient cleaning and disinfection of the load.
• The efficacy of a sterilizing program for the actual user load, even given
a constant consumable supply situation, can only be demonstrated by a
validation process. The manufacturer has only validated the test loads
pursuant to DIN EN 285.
• That a Bowie & Dick test was passed during the daily start-up
procedure only proves that steam penetration was satisfactory at the
time of testing. Any deterioration occurring as the day progresses will
remain unnoticed.
• Damaged and / or moist packaged items must be considered non-
sterile.
• If the sterilizer is deployed in a different place, environment conditions
may change.
2)
E.g. deviant process-relevant parameters as per DIN EN 285
Thermo Scientific
2 Safety considerations
15
50112712_082007_GB
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