In the case of a processed 1492V BI, a media and/or Nonwoven Material color change from purple
to yellow indicates a sterilization process failure. A negative pH color change result, i.e., media and
Nonwoven Material remain purple/blue, can be assessed at 48 hours.
13. Record the processed and control BI lot codes and results. Act immediately on any positive results
for processed biological indicators. Determine the cause of the positive biological indicator following
facility policies and procedures. Always retest the sterilizer and do not use sterilizer for processing
loads until qualification testing yields satisfactory results (typically three consecutive cycles
with negative biological indicator results and three consecutive cycles with passing Bowie-Dick
test results).
Storage
•
Best stored under normal room conditions: 59-86ºF (15-30ºC), 35-60% relative humidity.
•
Store away from direct sunlight. Do not store challenge packs near sterilants or other chemicals.
•
After use, the 3M™ Attest™ Steam Chemical Integrator will not change visually within 6 months
when stored at above conditions.
Disposal
Dispose of used 1492V BIs according to your health care facility policy. You may wish to steam sterilize
any positive biological indicators at 270°F (132°C) for 4 minutes or at 275°F (135°C) for 3 minutes in a
dynamic-air-removal steam sterilizer prior to disposal.
For further information, please contact your local 3M representative or contact us at 3M.com and select
your country.
Explanation of Symbols
Symbol Title
Manufacturer
Date of
Manufacture
Use-by date
Batch code
Catalogue
number
Do not re-use
Caution
Steam indicator
For more information, see HCBGregulatory.3M.com
Symbol
Indicates the medical device manufacturer as defined in EU
Directives 90/385/EEC, 93/42/EEC and 98/79/EC. Source: ISO
15223, 5.1.1
Indicates the date when the medical device was manufactured.
Source: ISO 15223, 5.1.3
Indicates the date after which the medical device is not to be
used. Source: ISO 15223, 5.1.4
Indicates the manufacturer's batch code so that the batch or lot
can be identified. ISO 15223, 5.1.5
Indicates the manufacturer's catalogue number so that the
medical device can be identified. ISO 15223, 5.1.6
Indicates a medical device that is intended for one use or for
use on a single patient during a single procedure. Source: ISO
15223, 5.4.2
Indicates the need for the user to consult the instructions for
use for important cautionary information such as warnings and
precautions that cannot, for a variety of reasons, be presented on
the medical device itself. Source: ISO 15223, 5.4.4
Indicates product is designed for use with steam sterilization
processes. Source: ISO 11140-1, 5.6
Description and Reference
7