Symbol Glossary - 3M Attest Manual De Instrucciones

Act immediately on any positive results for processed BIs. Determine the cause of the positive BI
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 BI results and three consecutive cycles with passing Bowie-Dick
test results).
Optional Visual pH Color Change Result
The 1492V BI is normally discarded after the fluorescent result has been recorded. If, however,
special studies are desired, 1492V BIs may be further incubated for a visual pH color change
result. After activation and during incubation, the white Nonwoven Material will absorb the
bromocresol purple indicator, the pH-sensitive indicator dye in the growth media, and appear
blue. In the case of the positive control BI a yellow color change of the growth media and/or
Nonwoven Material will appear within 48 hours. Any observation of a yellow color within the vial
indicates a positive result.
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.
Storage
• Best stored under normal room conditions: 59-86ºF (15-30ºC).
• Store away from direct sunlight. Do not store challenge packs near sterilants or
other chemicals.
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.

Symbol Glossary

Symbol Title
Manufacturer
Date of
Manufacture
Use-by date
Batch code
Catalogue
number
Do not re-use
Steam
indicator
For more information see, HCBGregulatory.3M.com
Symbol Description and Reference
Indicates the medical device manufacturer as defined in Medical
Device Regulation (EU) 2017/745 formerly EU Directive 93/42/
EEC. 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. Source : ISO 15223, 5.1.5
Indicates the manufacturer's catalogue number so that the
medical device can be identified. Source : 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 product is designed for use with steam sterilization
processes. Source: ISO 11140-1, 5.6
5