Sterilization Validation and Routine Control: Insight from ISO TC 198 Documents

Abstract

Sterilization, disinfection and decontamination methods are widely used to inactivate microorganisms, some of which can be harmful to humans. Sterilization validation is regulated globally by the International Organization for Standardization (ISO), particularly through Technical Committee (TC) 198, which addresses sterilization validation and routine control. These processes are crucial for ensuring the scientific and rational inactivation of microorganisms contributing to safer practices worldwide. Typically, Biological Indicators (BIs) are used for sterilization efficiency assessment. This paper will discuss sterilization validation, routine control and key considerations for their implementation in detail.

Keywords: Sterilization; Disinfection; Validation; Routine control; Biological indicator; International organization for standardization; Bioburden; D value