3M 1292 Benutzerhandbuch
Validation of Reduced Incubation Times (Readout Reliability Data)
The 3‑hour and 48‑hour incubation times have been correlated with a 7‑day incubation period. Sterilized indicators were examined daily for detection of a visual pH color change. The
3‑hour fluorescence change reading and the 48‑hour visual pH color change reading were compared to the 7‑day visual pH color change readings to determine the readout reliability of
the indicator. Readout reliability of the Attest™ 1292 rapid readout biological indicator was determined using the sensitivity calculation described below:
Sensitivity = (Number of Growth Positives after 168 hours) – (Number of False Negatives) X 100
Number of Growth Positives after 168 Hours
Attest™ 1292 Rapid Readout Biological Indicators
121°C (250°F) Gravity Displacement and 132°C (270°F) Vacuum Assisted
Steam Sterilization Processes
Validation of Reduced Incubation Time ‑ Readout Reliability Summary
Sterilization
Process
Incubation
Temperature
#
Tested
# Growth
Positives at
168 hours
Growth
Fluorescence
# False
Negatives at
48 hours
Sensitivity
at 48 hours
# False
Negatives at
3 hours
Sensitivity
at 3 hours
121°C (250°F)
Gravity
Displacement
60°C (140°F) 1620
800
5
99.4
0
100
132°C (270°F)
Vacuum
Assisted
60°C (140°F) 1270
654
2
99.7
0
100
These data demonstrate that ≥ 97% of the 7‑day (i.e. 168 hours) growth visual positives were detected by fluorescence within 3 hours of incubation and by the visual pH color within
48 hours of incubation. The 3M™ Attest™ 1292 Rapid Readout Biological Indicator therefore meets readout reliability of ≥ 97% for the 3 hour fluorescence results and the 48 hour
visual color change results.
Explanation of Symbols
Caution, see instructions for use
Do not reuse
Use by date
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For France and other countries that
recognize the CE mark for this device.
Made in U.S.A. by
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