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ANSI/AAMI/ISO 11737-2:2019

Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Summary

Specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a sterilization process. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2019
Page Count 29
Themes Sterilization—Industrial
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