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Optional Visual pH Color Change Result
The 1491 BI is normally discarded after the fluorescent result has been recorded. If, however, special studies are desired, 1491 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 24 hours. Any
observation of a yellow color within the vial indicates a positive result.
In the case of a processed 1491 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 24 hours.
Storage
• Best stored in original box under normal room conditions: 59-86ºF (15-30ºC), 35-60% relative humidity (RH).
• Do not store 1491 BIs near sterilants or other chemicals.
Disposal
Dispose of used 1491 BIs according to your health care facility policy. You may wish to steam sterilize any positive biological indicators at 121°C/250°F for at least 30 minutes,
or at 132°C/270°F for 10 minutes in a gravity displacement steam sterilizer, or at 132°C/270°F for 4 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
Caution
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 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
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