DIN EN 16442:2015-05

The recommendation of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute (RKI) on hygiene requirements for the processing of flexible endoscopes and additional endoscopic instruments points out that endoscopes should be stored completely dry, dust-protected and preferably hanging in a special endoscope cabinet close to the workplace. The RKI recommendation does not provide any concrete information on the question of how long processed endoscopes can be stored without contamination. Studies from the USA have shown that if a correctly prepared flexible endoscope (with compressed air drying of the endoscope channels) is properly stored for 5 to 7 days, there is no recontamination and therefore no need for processing immediately before use in routine operation of larger endoscopy units. This standard on controlled environment storage cabinets sets performance requirements and appropriate tests for cabinets that are applicable after automatic or manual processing for storage and drying of thermolabile endoscopes. The controlled environment should ensure that the microbial quality of the endoscope does not deteriorate during storage. The drying function of the storage cabinet for thermolabile endoscopes is designed to take over, if necessary, any additional drying as part of the automatic or manual processing cycle. Among other things, requirements are specified for storage, drying, ambient conditions in the storage cabinet, for example air quality, pressure, temperature, display devices and test methods. The cabinet is not intended to provide any cleaning or disinfection function. The standard has been prepared by Technical Committee CEN/TC 102 "Sterilizers for medical purposes", the secretariat of which is held by DIN. The responsible German Working Committee is NA 063-04-09 AA "Reinigungs-Desinfektionsgeräte" ("Washer-disinfectors") at DIN Standards Committee Medicine (NAMed).