ABSTRACT

In 1994, the Association for the Advancement of Medical Instrumentation (AAMI) adopted ISO 11134, “Sterilization of Health Care Products—Requirements for Validation and Routine Control—Industrial Moist Heat Sterilization” as the replacement for ANSI/AAMI ST25-1987, “Guideline for Industrial Moist Heat Sterilization of Medical Products.” Unlike its sister document concerning industrial ethylene oxide (EO), ANSI/AAMI ISO 11135, AAMI/ISO 11134 contains virtually no specific requirements or guidance in the area of validation. For example, there is no mention of the number of temperature-monitoring locations or the number of repetitive runs. The writers considered this a notable achievement; however, it has lead to numerous requests for assistance. (It should be noted that ST25 does not provide this type of guidance either.)