Sterilization is a validated process used to render product free from viable microorganisms. Depending on the intended use, some semi-critical and all critical medical devices should be sterilized before next use.
Reference standard:
FDA Guidance for industry and Food and Drug Administration Staff Reprocessing medical devices in healthcare setting: Validation Methods and Labeling
AAMI TIR 12: 2020
ISO 17664-1: 2021
ISO 17665-1: 2006
ISO 14937:2009
ISO 11138-1:2017
ASTM E1766-2015 YY/T 0802-2020
GB 18278.1-2015
WS/T 367-2012
WS 310.1-2016
WS 310.2-2016
WS 310.3-2016
Sterilization efficacy test methods
Microbiological method
Moist heat (steam) sterilization, EO sterilization, Hydrogen peroxide sterilization, Dry heat sterilization, Liquid chemical sterilization etc.
