Sterilization of health care products. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Sterilization of health care products. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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1   Scope

1.1   This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.