Biological indicator

Also called: BI, spore test

Biological indicator — A carrier holding a known population of highly resistant bacterial spores, used to test whether a sterilization process actually kills microorganisms.

Steam and hydrogen-peroxide processes are usually challenged with Geobacillus stearothermophilus spores, and ethylene oxide with Bacillus atrophaeus. After the cycle the indicator is incubated; no growth means the spores were inactivated.

Biological indicators are specified in the ISO 11138 series. They are the reference test for validation, implant loads and periodic monitoring, alongside physical records and chemical indicators.

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