Indicators

GETINGE ASSURED EO SELF-CONTAINED BIOLOGICAL INDICATOR

The Getinge Assured EO Self-Contained Biological Indicator is for bio-logical testing of ethylene oxide sterilizers. The Self-Contained Biological Indicator contains 106 Bacillus Atrophaeus.

PERFORMANCE CHARACTERISTICS

After exposure to ethylene oxide, the biological indicator, when incubated will indicate either growth or no growth.

Color Change (Biological Vial Process Indicator) :Blue to brown

Color Change (Growth Media):Red to yellow

Color Change (Media if No Growth is Present): No color change

Complete Kill Time:30-45 minutes at 600 mg/L, 60±10% RH, 130°F

Stated Values: alues: (as determined in an EO resistometer) 45 minutes at 600mg/L, 45-60% RH, 130°F

Incubation Time:48 hours at 35-39°C

PHYSICAL CHARACTERISTICS

Dimensions:48mm L x 10mm W

Biological Indicator: 10 Bacillus atrophaeus

Quantity: 50 EO Self-Contained Biological Indicators

ENVIRONMENTAL LIMITATIONS:

Storage: Storage: Store at normal room temperature. Do not dessicate. Do not store near sterilants or other chemicals.

SHELF LIFE

24 months; the expiry date is printed on the product packaging.

STANDARDS CLASSIFICATION

ANSI/AAMI/ISO 11138

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Chemical Indicators :-

Chemical indicator, any substance that gives a visible sign, usually by a colour change, of the presence or absence of a threshold concentration of a chemical species, such as an acid or an alkali in a solution. An example is the substance called methyl yellow, which imparts a yellow colour to an alkaline solution. If acid is slowly added, the solution remains yellow until all the alkali has been neutralized, whereupon the colour suddenly changes to red.

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