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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device digital physical/chemical sterilization process sensor
Definition A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.
Product CodeSBE
Regulation Number 880.2801
Device Class 2

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