EN 16442:2015

Controlled environment storage cabinet for processed thermolabile endoscopes EN 16442:2015

Publication date:   Jul 16, 2015

General information

90.93 Standard confirmed   Nov 19, 2020

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.140   Hospital equipment

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Scope

This European Standard specifies the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing.
The storage cabinets are designed to provide a controlled environment for storage of endoscope(s), with or without channels, and when necessary drying of the endoscope(s), including the endoscope(s) channels.
The controlled environment provided by the storage cabinet ensures that during storage there is no deterioration of the microbiological quality of the endoscope. The drying function is intended to supplement, if necessary, any drying provided as part of the automated or manual processing cycle.
This European Standard specifies storage cabinets which flush the channels and the external surfaces of endoscopes with air.
NOTE 1 The storage cabinet is one of the means that can allow the safe use of the endoscope for an extended period from the time of processing and improve availability for emergency use.
NOTE 2 Thorough drying of an endoscope in a washer-disinfector can require a prolonged cycle time; the use of a storage cabinet including a drying function can enhance throughput of the endoscopes.
The cabinet is not intended to provide any cleaning or disinfection function.
This European Standard does not include the use of other chemicals for drying and maintaining the quality of endoscopes during storage

Life cycle

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PUBLISHED
EN 16442:2015
90.93 Standard confirmed
Nov 19, 2020