AAMI ST41-99


Good Hospital Practice: Ethylene Oxide Sterilization and Sterility Assurance
standard by Association for the Advancement of Medical Instrumentation, 07/31/1999

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Covers the safe and effective use of ethylene oxide as a sterilant, with provisions intended to promote the achievement of sterilization with inhospital EO sterilizers, the maintenance of sterility of processed items, and the reduction of occupational exposure to EO.

This 100-page document incorporates two previously published recommended practices: the second edition of “Good hospital practice: Ethylene oxide sterilization and sterility assurance” (ANSI/AAMI ST41-1992) and the third edition of “Good hospital practice: Ethylene oxide gas – Ventilation recommendations and safe use “(ANSI/AAMI ST43-1993). Combining these two recommended practices provides all of AAMI?s recommendations concerning inhospital EO sterilization in a single document for ease of reference. The provisions of the previously published recommended practices have been updated to reflect new regulatory and technological developments, especially with respect to EO monitoring, EO emission control, and new diluents that have come into use as substitutes for chlorofluorocarbon-12 (CFC-12).

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