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
EN 16442:2015 Referenced Document
EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking*， 2024-04-20 Update
EN 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances*， 2024-04-20 Update
EN 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
EN ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness
EN ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods ISO 14644-3: 2005*， 2024-04-20 Update
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ISO 8573-1:2010 Compressed air - Part 1: Contaminants and purity classes
EN 16442:2015 history
2015EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes