ABSTRACT
The Advancement of Medical Instrumentation Industrial Moist Heat Working Group is drafting a technical information report, which should provide the type of information. The intent and the wording of the International Organization for Standardization (ISO) moist heat document is that product be routinely released parametrically. Sterility testing and biological indicators (BI) are used in cycle development and as an exception for batch release. Comite Europeen de Normalisation (CEN) moist heat ignores BIs, which also neatly removes the need for half cycles. Both CEN and ISO moist heat require that the resistance of the bioburden to the sterilization process be known. The guidance in the Ethylene oxide document provides defined numbers of BI and temperature sensors, based on load volumes, for both validation and routine BI use. These numbers are generally considered to be excessive for large ethylene oxide sterilizers. EN 554 recommends 12 temperature sensors per cubic meter for moist heat.
