HIGHPOWER Letter to AAMI Regarding FDA Steam BI Requirements

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April 20th, 2015 Association for the Advancement of Medical Instrumentation 4301 N Fairfax Drive Suite 301 Arlington, VA 22203-1633 USA RE: Current FDA Resistance Requirements for Steam Biological Indicators Used in Validation Dear AAMI, In recent conversations with FDA, we became aware that there are now different requirements for the resistance characteristics (D-value and Z-value)… Read more »