Chemical indicators are analysed in 6 categories according to ISO-11140 standards:
Type I Process indicators: used to distinguish between treated and untreated products and applied to the outside of the package (Exposure bands - labels with indicators). They do not provide information on sterilisation efficiency.
Type II Indicators used in specific tests: Bowie-Dick defines specific tests related to the test
Type III Single variable indicators: Indicators that monitor a single parameter of the sterilisation process such as temperature or time.
Type IV Multivariable indicators: Indicators that can monitor more than one parameter such as temperature/time, time/steam quality, time/steam quality/temperature and can show a 2°C drop in temperature and a 0-25% difference in the tested parameter.
Type V Integrators: Monitor a narrower range than multi-parameter indicators. They can show a 1ºC drop in temperature and 0-15% variation in the parameter under test. Can be used as a colour changing or progressive strip. In order for the integrator to change colour or progress, all the physical conditions necessary to reach certain D and Z values within the circle must be met. These values must be equivalent to or superior to the performance requirements of ISO 11138 for the biological indicator according to ISO 11140-1. However, they cannot replace the biological indicator.
Type VI Emulation indicators: These indicators, called emulators, can show a 1°C drop in temperature and a 0-6% difference in the parameter under test. They are cycle specific indicators. For different sterilisation cycles, emulator indicators produced for those cycles should be used. For example, a type 6 indicator produced for 7 minutes at 134°C cannot be used in a steam steriliser that cycles at 134°C for 5 minutes.
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