EN 16442:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and procedure requirements
6 Testing for conformity
7 Documentation
8 Information to be supplied with the storage cabinet
9 Information to be requested from the purchaser by the
  manufacturer
Annex A (informative) - Summary of test programmes
Annex B (informative) - Cross-contamination between endoscopes
Annex C (normative) - Methods for evaluation of airborne microbial
        contamination in the storage cabinet
Annex D (informative) - Procedure for parametric performance
        qualification
Annex E (normative) - Internal residual contamination of endoscopes
        after storage
Annex F (normative) - Establishing endoscope type test groups
Annex G (normative) - Establishing endoscope product families
Bibliography

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 1The 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 2Thorough 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