AAMI TIR 13-97

Provides guidance for industrial users of moist heat sterilization including the interrelationship of product and process, the major types of moist heat sterilization cycles, and microbiological and engineering aspects of process development. Also includes information and guidance on validation, vessel equivalency, minimum number of replicate cycles, and decision-making for revalidation, as well as routine processing (process control, change control, preventive maintenance of equipment and safety). Companion document to ANSI/AAMI/ISO 11134.