Document ID:	AAMI-11138-2       Scroll down to access document images

Overview

Title:  Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes Scope:  This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 Degrees C to 65 Degrees C. Status:  Active Adoption Date:  22-MAY-2012         Next Review Due:  29-APR-2035 FSC/Area:  6530 Doc Category:   Association for the Advancement of Medical Instrumentation   Reaffirmation Date:  01-MAY-2025

Responsibilities

Lead Standardization Activity:  DM  DLA Troop Support - Medical Items of Supply     Adopting Activity: MB  Defense Health Agency, Medical Logistics Division Coordination:  Full   Army Custodian:  MD   Office of the Surgeon General   Navy Custodian:  SH   Naval Sea Systems Command (Ship Systems)   Air Force Custodian:  03   HQ USAF Office of the Surgeon General

Revision History

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