This document provides requirements for sampling, analysis and culturing methods for the determination of endoscope contamination level in clinical use, including routine sampling used for monitoring the microbiological quality of patient ready endoscopes, validation, performance qualification and verification of the effectiveness of the endoscope processing. It also provides implementation guidance and information on actions recommended in case a contamination is detected.
This document does not apply to rigid endoscopes, and endocavity ultrasound probes.
Registration number (WIID)
89497
Scope
This document provides requirements for sampling, analysis and culturing methods for the determination of endoscope contamination level in clinical use, including routine sampling used for monitoring the microbiological quality of patient ready endoscopes, validation, performance qualification and verification of the effectiveness of the endoscope processing. It also provides implementation guidance and information on actions recommended in case a contamination is detected.
This document does not apply to rigid endoscopes, and endocavity ultrasound probes.
