EN 16442:2015

Controlled environment storage cabinet for processed thermolabile endoscopes

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

Lagerungsschrank mit geregelten Umgebungsbedingungen für aufbereitete, thermolabile Endoskope

Diese Europäische Norm legt die Leistungsanforderungen fest, die für Schränke zum Lagern oder zum Lagern und Trocknen thermolabiler Endoskope nach der maschinellen oder manuellen Aufbereitung gelten.
Die Lagerungsschränke sind dafür ausgelegt, geregelte Umgebungsbedingungen für die Lagerung eines Endoskops/von Endoskopen, mit und ohne Kanälen bereitzustellen, und, wenn erforderlich, ein Endoskop/Endoskope einschließlich der Endoskopkanäle zu trocknen.
Mit der durch den Lagerungsschrank hergestellten geregelten Umgebung wird sichergestellt, dass während der Lagerung keine Verschlechterung der mikrobiologischen Beschaffenheit des Endoskops auftritt. Die Trocknungsfunktion ist dafür vorgesehen, falls erforderlich jegliche Trocknungen im Rahmen des maschinellen oder manuellen Aufbereitungszyklus zu ergänzen.
Diese Europäische Norm gilt für Lagerungsschränke, die die Kanäle und die Außenoberflächen von Endoskopen mit Luft spülen.
ANMERKUNG 1 Der Lagerungsschrank ist eines der Mittel, die den sicheren Gebrauch des Endoskops über einen längeren Zeitraum nach der Aufbereitung erlauben und die Verfügbarkeit für Notfälle verbessern können.
ANMERKUNG 2 Das gründliche Trocknen eines Endoskops in einem Reinigungs-Desinfektionsgerät kann eine verlängerte Zyklusdauer erfordern; die Verwendung eines Lagerungsschrankes mit Trocknungsfunktion kann die Endoskopverfügbarkeit im Gesamtprozess erhöhen.
Der Schrank ist nicht dafür vorgesehen, eine Reinigungs- oder Desinfektionsfunktion bereitzustellen.
Diese Norm gilt nicht für die Verwendung von anderen Chemikalien zur Trocknung und Aufrechterhaltung der Beschaffenheit von Endoskopen während der Lagerung.

Enceinte de stockage à atmosphère contrôlée pour endoscopes thermosensibles traités

La présente Norme européenne définit les exigences de performance qui s’appliquent aux enceintes destinées au stockage, ou au stockage et au séchage d’endoscopes thermosensibles, après le traitement manuel ou automatique de ces derniers.
Les enceintes de stockage sont destinées à fournir une atmosphère contrôlée pour le stockage d'un ou de plusieurs endoscopes (avec ou sans canaux) et, quand cela est nécessaire, pour leur séchage (en incluant leurs canaux).
L’atmosphère contrôlée fournie par l’enceinte de stockage permet de prévenir toute dégradation de la qualité microbiologique de l’endoscope pendant la période de stockage. La fonction de séchage est prévue pour compléter, le cas échéant, tout processus de séchage faisant partie du cycle de traitement manuel ou automatique des endoscopes.
La présente Norme européenne définit les enceintes de stockage qui soufflent les canaux et les surfaces extérieures des endoscopes avec de l'air.
NOTE 1   L'enceinte de stockage est l’un des moyens permettant d’utiliser l’endoscope en toute sécurité pendant une période prolongée à partir de son traitement et d’améliorer sa disponibilité en cas d’urgence.
NOTE 2   Le séchage complet d’un endoscope dans un laveur désinfecteur peut nécessiter un temps de cycle prolongé ; l’utilisation d’une enceinte de stockage dotée d’une fonction de séchage peut améliorer le taux d’utilisation des endoscopes.
L’enceinte n’est pas prévue pour assurer une fonction de lavage ou de désinfection.
La présente Norme européenne n'inclut pas l'utilisation d'autres produits chimiques pour le séchage et le maintien de la qualité des endoscopes pendant le stockage.

Shranjevalni prostor z nadzorovanim okoljem za pripravljene termolabilne endoskope

Predlagani standard določa zahteve glede zmogljivosti prostorov za shranjevanje in sušenje občutljivih endoskopov (SCHE) po samodejni ali ročni pripravi za ponovno uporabo. Shranjevalni prostori zagotavljajo nadzorovano okolje za shranjevanje endoskopov in, kadar je to potrebno, njihovo sušenje, vključno z endoskopskimi kanali. Nadzorovano okolje zagotavlja, da se med shranjevanjem ne poslabša mikrobna kakovost endoskopa. Faza sušenja je namenjena kot dopolnilo, če je to potrebno, vsakemu sušenju, ki je del samodejnega ali ročnega cikla priprave na ponovno uporabo. Prostor ni namenjen za nobeno funkcijo čiščenja oziroma dezinfekcije. OPOMBA 1: Uporaba shranjevalnega prostora lahko dovoljuje varno uporabo endoskopa dlje časa po pripravi za ponovno uporabo in lahko izboljša razpoložljivost za uporabo v sili. OPOMBA 2: Temeljito sušenje endoskopa v pralno-dezinfekcijskem pripomočku lahko zahteva daljši čas cikla; uporaba shranjevalnega prostora pa lahko poveča pretok endoskopov.

General Information

• Status: Published
• Publication Date: 17-Mar-2015
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 8 - Performance requirements and testing for washer-disinfectors
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 19-Nov-2020
• Completion Date: 23-Sep-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 16442:2015 - Controlled environment storage cabinet for processed thermolabile endoscopes

Overview - EN 16442:2015 in brief

EN 16442:2015 is the CEN European Standard that specifies performance and testing requirements for controlled environment storage cabinets for processed thermolabile endoscopes. It covers cabinets that store - and where required, dry - endoscopes after manual or automated reprocessing. The objective is to ensure that storage does not allow deterioration of the endoscope’s microbiological quality; the standard explicitly does not cover cleaning or disinfection functions and notes that these cabinets are not considered medical devices.

Key topics and technical requirements

• Controlled environment and storage: Cabinets must maintain a controlled atmosphere so microbiological quality of endoscopes is not degraded during the storage cycle (see Clause 4).
• Drying function: Optional drying phases and controlled drying temperature bands are specified to supplement drying from washer-disinfectors.
• Channel flushing and aeration: Cabinets covered by EN 16442 flush endoscope channels and external surfaces with air; ESC (endoscope storage cabinet) connectors and channel aeration systems are addressed.
• Air quality and filtration: Requirements and tests for air changes, filtration and airborne microbial contamination (see Clause 6 and Annex C).
• Mechanical, instrumentation and monitoring: Materials, design, temperature/humidity/pressure indicators, cycle/fault indicators, and traceability requirements (Clauses 5 and 8).
• Risk analysis and conformity testing: Manufacturers must perform risk analysis (e.g., cross-contamination, ingress during loading) and confirm performance by tests for drying, contamination of cabinet surfaces, thermometric testing, overpressure, channel aeration and air quality (Clause 6, Annexes B, E).
• Documentation and labelling: Detailed information to be supplied with the cabinet, marking and installation/operational instructions (Clause 8).

Practical applications - who uses this standard

• Endoscope storage cabinet manufacturers: to design and verify compliant products.
• Hospital procurement and clinical engineering: to specify, evaluate and accept cabinets for endoscope reprocessing workflows.
• Infection prevention and control teams / CSSD: to implement storage practices that preserve microbiological quality and support throughput.
• Biomedical and facilities engineers: for installation, validation and maintenance (testing, traceability and monitoring).
• Regulatory and compliance personnel: to align documentation and risk assessments with European normative expectations.

Related standards and references

• EN ISO 14971 (risk management guidance referenced for risk analysis)
• ISO 15883 (washer-disinfectors; thermal disinfection context)
• EN ISO 14644-3, EN 60584-1, EN 60751 (test and instrumentation standards cited in the normative references)

Keywords: EN 16442:2015, controlled environment storage cabinet, processed thermolabile endoscopes, endoscope storage, endoscope drying, channel aeration, microbiological quality.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Shranjevalni prostor z nadzorovanim okoljem za pripravljene termolabilne endoskopeLagerungsschrank mit geregelten Umgebungsbedingungen für aufbereitete, thermolabile EndoskopeEnceinte de stockage à atmosphère contrôlée pour endoscopes thermosensibles traitésControlled environment storage cabinet for processed thermolabile endoscopes11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 16442:2015SIST EN 16442:2015en,fr,de01-maj-2015SIST EN 16442:2015SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16442
March 2015 ICS 11.140 English Version
Controlled environment storage cabinet for processed thermolabile endoscopes
Enceinte de stockage à atmosphère contrôlée pour endoscopes thermosensibles traités
Lagerungsschrank mit geregelten Umgebungsbedingungen für aufbereitete, thermolabile Endoskope 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16442:2015 ESIST EN 16442:2015

Page
Foreword . 4 Introduction . 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions . 6 4 Performance requirements . 7 4.1 General . 7 4.2 Storage . 8 4.3 Drying . 8 4.4 Endoscope storage cabinet connectors (ESC connectors) . 9 5 Mechanical and procedure requirements . 9 5.1 Materials – design, manufacture and assembly . 9 5.2 Air quality . 10 5.3 Contamination of the storage cabinet chamber surfaces . 11 5.4 Drying process control . 11 5.5 Endoscope channel aeration system . 12 5.6 Automatic temperature control . 13 5.7 Fault indication/monitoring . 13 5.8 Cycle indicators . 14 5.9 Instruments and control devices . 14 5.10 Temperature indicators . 15 5.11 Relative humidity indicator . 15 5.12 Pressure indicators . 15 5.13 Traceability . 16 5.14 Double-ended storage cabinets . 16 6 Testing for conformity . 17 6.1 General . 17 6.2 Air changes . 17 6.3 Overpressure . 17 6.4 Drying . 18 6.5 Contamination of the inside surfaces of the storage cabinet . 19 6.6 Air quality . 19 6.7 Channel aeration test . 21 6.8 Thermometric testing 1 – chamber and load temperature testing. 21 6.9 Thermometric test 2- chamber and load temperature testing . 22 6.10 Readability . 22 6.11 Tests for air filtration . 22 7 Documentation . 22 8 Information to be supplied with the storage cabinet . 22 8.1 General . 22 8.2 Information to be supplied before delivery . 23 8.3 Marking and labelling . 25 8.4 Packaging . 25 9 Information to be requested from the purchaser by the manufacturer . 25 Annex A (informative) Summary of test programmes . 26 Annex B (informative) Cross-contamination between endoscopes . 28 SIST EN 16442:2015

in the storage cabinet . 31 Annex D (informative) Procedure for parametric performance qualification . 32 Annex E (normative) Internal residual contamination of endoscopes after storage . 38 Annex F (normative) Establishing endoscope type test groups . 46 Annex G (normative) Establishing endoscope product families . 55 Bibliography . 59
ESC connector device used to connect endoscope channels inside the cabinet to the flushing system 3.5 endoscope surrogate device item designed to represent construction elements of endoscope specific characteristics affecting the flow conditions in an endoscope Note 1 to entry: Construction elements can include channel length and diameter, connectors, channel separators, port closures, return valves, etc. 3.6 processing activity including cleaning, disinfection and sterilization (if necessary and applicable), to prepare a new or used medical device for its intended use 3.7 storage cabinet equipment controlled by an automatic control system that maintains the microbiological quality of processed thermolabile endoscope 3.8 storage cycle time between connecting and disconnecting the endoscope(s) inside the storage cabinet Note 1 to entry:
A storage cycle can include a drying phase. 3.9 storage temperature band range of temperatures expressed as the minimum and the maximum controlled temperatures, which may prevail throughout the load during storage 3.10 thermolabile damaged by exposure to temperatures within the range used for thermal disinfection Note 1 to entry: The minimum temperature for thermal disinfection specified in ISO 15883-1 is 65°C. 4 Performance requirements 4.1 General 4.1.1 Storage cabinets are designed to provide a controlled environment for storage of endoscopes (with or without channels). The controlled environment provided by the cabinet shall ensure that during storage there is no deterioration of the microbiological quality of the endoscope. An optional drying function is intended to supplement, if necessary, any drying provided as part of the automated or manual processing cycle The cabinet is not intended to provide any cleaning or disinfection function. NOTE 1 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. NOTE 2 Table A.1 gives a summary of the tests and Clause 6 on the test methods that can be used to check that the storage cabinets meet the specified requirements. 4.1.2 Detailed requirements for information to be provided by the manufacturer are specified in Clause 8. SIST EN 16442:2015

Any requirements regarding the quality of the air supplied to the storage cabinet (see 5.2) shall be specified [see 8.2 f) 1)]. 4.2.6 The maximum storage time in the storage cabinet shall be determined [see 8.2 c)] NOTE The maximum storage time can be limited by national or regional recommendations or regulations. 4.3 Drying For storage cabinets that provide a drying function [see 8.2 d) 1)] the following requirements apply: a) The time required to dry the endoscopes [see 8.2 d) 4)] shall be specified when tested according to 6.4 and shall not exceed 3 hours. NOTE 1 Drying times can be different according to the type of endoscope involved. NOTE 2 3 hours is an acceptable drying time to reduce the potential risk of growth of microorganisms present in endoscope channels. SIST EN 16442:2015
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