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Chemical and process indicators
These are a wide variety of chemical sterilization indicators based on reactive inks that change color when exposed to sterilization processes.
Three Main Applications of Chemical Indicators
ISO 11140-1:2014 regulates chemical indicators used for:
- Distinguishing items that have been sterilized from those that have not
- Performing specific tests, such as the Bowie-Dick test
- Assessing the achievement of critical sterilization parameters at the point of placement
The completion of a chemical or process indicator should not be considered as evidence of an acceptable sterility assurance level, but rather as one of several factors to consider when evaluating the acceptability of a sterilization process.
Three Main Categories of Chemical Indicators by Use
ISO 11140-1:2014 divides chemical indicators into six classes, grouped into three main categories based on intended use:
- Process Indicators – Used to distinguish products that have undergone the cycle from those that have not. Example: indicator tape
- Indicators for Specific Tests – For example, the Bowie-Dick test
- Parametric, Integrating, and Emulating Indicators – Designed to respond to critical process parameters and indicate exposure to a set value for each parameter. Example: strips with a color-changing band in response to specific combinations of time, temperature, and steam quality
They are regulated by ISO 11140-1 – Sterilization of health care products: Chemical indicators.
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