Disinfection is used to render a device safe to handle and mitigate the transmission of pathogenic organisms. Disinfection can be included as an optional process step in an instruction for use (IFU) to render devices safe for handling in preparation for the terminal process. This optional disinfection step can be performed by automated (i.e., washer-disinfector) or manual (i.e., disinfectant wipe or immersion in a chemical disinfectant) processes.

Disinfection is a process that destroys pathogens and other microorganisms by physical or chemical means. Disinfection processes, including high-level disinfection, do not ensure the same margin of safety associated with sterilization processes.

The CDC issued Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, which recognizes the following three disinfection levels:

a)  low-level disinfection;  

b)  intermediate-level disinfection;  

c)  high-level disinfection.

Referred Standards:

FDA Guidance for industry and Food and Drug Administration Staff

AAMI TIR 12: 2020

ISO 17664: 2017

ISO 15883-1

ISO 15883-2

WS/T 367-2012  

WS 310.1-2016   

WS 310.2-2016   

WS 310.3-2016   

Disinfection and validation Methods:

Disinfection validation process:

Test duration: 4~6 weeks 

 At least 8 replicate samples used in Disinfection test.