Validation of Reduced Incubation Times (Readout Reliability Data)

The 3hour and 48hour incubation times have been correlated with a 7day incubation period. Sterilized indicators were examined daily for detection of a visual pH color change. The

3hour fluorescence change reading and the 48hour visual pH color change reading were compared to the 7day 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

 

 

 

# Growth

Growth

Fluorescence

Sterilization

Incubation

#

# False

 

# False

 

Positives at

Sensitivity

Sensitivity

Process

Temperature

Tested

Negatives at

Negatives at

168 hours

at 48 hours

at 3 hours

 

 

 

 

48 hours

 

3 hours

 

121°C (250°F)

 

 

 

 

 

 

 

Gravity

60°C (140°F)

1620

800

5

99.4

0

100

Displacement

 

 

 

 

 

 

 

132°C (270°F)

 

 

 

 

 

 

 

Vacuum

60°C (140°F)

1270

654

2

99.7

0

100

Assisted

 

 

 

 

 

 

 

These data demonstrate that ≥ 97% of the 7day (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

Batch code

Manufacturer

Catalog number

For France and other countries that recognize the CE mark for this device.

Made in U.S.A. by

3M Health Care

2510 Conway Ave.

St. Paul, MN 55144 1-800-228-3957 www.3M.com

3M and Attest are trademarks of 3M. Used under license in Canada.

© 2013, 3M. All rights reserved.

3M Deutschland GmbH

Health Care Business

Carl-Schurz-Str. 1

41453 Neuss

Germany

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3M 1292 manual Explanation of Symbols, Growth Fluorescence, Made in U.S.A. by 3M Health Care Conway Ave

1292 specifications

The 3M 1292 is a high-performance adhesive transfer tape that has gained considerable recognition in various industrial and commercial applications. Known for its reliability and versatility, the 3M 1292 is designed to meet the demands of different industries while providing exceptional bonding strength.

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