National foreword

This British Standard is the UK implementation of EN 16442:2015.

The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2015.

This European Standard was approved by CEN on 19 December 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Foreword

This document (EN 16442:2015) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2015 and conflicting national standards shall be withdrawn at the latest by September 2015.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Introduction

Endoscope storage cabinets are designed to provide a controlled environment for the storage of endoscope(s) (with or without channels) and, if 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 conducted during automated or manual processing of the endoscope.

The storage cabinet is designed to allow for the safe use of endoscopes at an extended period from the time of processing improving availability for use.

NOTE 1 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 increase the number of endoscopes that can be processed in the washer-disinfector for a defined time period.

NOTE 2 It is strongly recommended to verify the microbiological quality of the endoscopes intended to be stored in the cabinet before installation of the storage cabinet.

NOTE 3 The storage cabinet is not designed to clean and/or disinfect endoscopes and any contaminated endoscope stored in the cabinet can still be contaminated after the storage period.

NOTE 4 Storage cabinets for processed thermolabile endoscopes are not considered as medical devices.

1 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

2 Normative references

3 Terms and definitions

4 Performance requirements

4.1 General

4.2 Storage

4.3 Drying

4.4 Endoscope storage cabinet connectors (ESC connectors)

5 Mechanical and procedure requirements

5.1 Materials - design, manufacture and assembly

5.2 Air quality

5.3 Contamination of the storage cabinet chamber surfaces

5.4 Drying process control

5.5 Endoscope channel aeration system

5.6 Automatic temperature control

5.7 Fault indication/monitoring

5.8 Cycle indicators

5.9 Instruments and control devices

5.10 Temperature indicators

5.11 Relative humidity indicator

5.12 Pressure indicators

5.13 Traceability

5.14 Double-ended storage cabinets

6 Testing for conformity

6.1 General

6.2 Air changes

6.3 Overpressure

6.4 Drying

6.5 Contamination of the inside surfaces of the storage cabinet

6.6 Air quality

6.7 Channel aeration test

6.8 Thermometric testing 1 - chamber and load temperature testing

6.9 Thermometric test 2- chamber and load temperature testing

6.10 Readability

6.11 Tests for air filtration

7 Documentation

8 Information to be supplied with the storage cabinet

8.1 General

8.2 Information to be supplied before delivery

8.3 Marking and labelling

8.4 Packaging

9 Information to be requested from the purchaser by the manufacturer

9.1

9.2

Bibliography

BS EN 16442:2015

Controlled environment storage cabinet for processed thermolabile endoscopes

Current

Published:

31 Mar 2015