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sterilization

Standard

ECSS-Q-ST-70-53C - Materials and hardware compatibility tests for sterilization processes (15 November 2008)

Definition

validated process used to render product free from viable micro-organisms

Notes

NOTE In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a micro-organism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero. [ISO 11139]

Relations

ECSS-Q-ST-70-53C — direct effect
ECSS-Q-ST-70-53C — long duration effect
ECSS-Q-ST-70-39C — process
ECSS-S-ST-00-01C — process
ECSS-S-ST-00-01C — product
ECSS-Q-ST-70-53C — sterility assurance level
ECSS-Q-ST-60-12C — validated process

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