This document provides requirements for sampling, culturing and analysis methods for assessing residual
microbial contamination in clinical use of reusable flexible endoscopes and endoscope valves that are
terminally processed prior to clinical use. It also provides implementation guidance and information on
actions recommended if contamination is detected.
This document does not apply to rigid endoscopes and endocavity ultrasound probes.
Registration number (WIID)
83953
Scope
This document provides requirements for sampling, culturing and analysis methods for assessing residual
microbial contamination in clinical use of reusable flexible endoscopes and endoscope valves that are
terminally processed prior to clinical use. It also provides implementation guidance and information on
actions recommended if contamination is detected.
This document does not apply to rigid endoscopes and endocavity ultrasound probes.