1、May 2015 Translation by DIN-Sprachendienst.English price group 22No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11
2、.140!%B_“2315860www.din.deDDIN EN 16442Controlled environment storage cabinet for processed thermolabileendoscopes;English version EN 16442:2015,English translation of DIN EN 16442:2015-05Lagerungsschrank mit geregelten Umgebungsbedingungen fr aufbereitete, thermolabileEndoskope;Englische Fassung EN
3、 16442:2015,Englische bersetzung von DIN EN 16442:2015-05Enceinte de stockage atmosphre contrle pour endoscopes thermosensibles traits;Version anglaise EN 16442:2015,Traduction anglaise de DIN EN 16442:2015-05www.beuth.deDocument comprises 61 pagesIn case of doubt, the German-language original shall
4、 be considered authoritative.04.15 DIN EN 16442:2015-05 2 A comma is used as the decimal marker. National foreword This document (EN 16442:2015) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in
5、 its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-09 AA Reinigungs-Desinfektionsgerte. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16442 March 2015 ICS 11.140 English Version Controlled environment storage cabinet for proces
6、sed thermolabile endoscopes Enceinte de stockage atmosphre contrle pour endoscopes thermosensibles traits Lagerungsschrank mit geregelten Umgebungsbedingungen fr aufbereitete, thermolabile Endoskope This European Standard was approved by CEN on 19 December 2014. CEN members are bound to comply with
7、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 Managem
8、ent 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 statu
9、s 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,
10、 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN A
11、ll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16442:2015 EContents 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 Dryi
12、ng . 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 ae
13、ration 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
14、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
15、.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 Pac
16、kaging 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 EN 16442:2015 (E) DIN EN 16442:2015-05 2 Annex C (normative) Methods for evaluation of airborne
17、microbial contamination in the storage cabinet31 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) Establi
18、shing endoscope product families 55 Bibliography . 59 EN 16442:2015 (E) DIN EN 16442:2015-05 3 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
19、 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 ma
20、y 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
21、, 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,
22、Switzerland, Turkey and the United Kingdom. EN 16442:2015 (E) DIN EN 16442:2015-05 4 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 endosco
23、pe(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
24、 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
25、 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.
26、 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. EN 16442:2015
27、 (E) DIN EN 16442:2015-05 5 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 stor
28、age 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 dry
29、ing 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 t
30、hat 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 e
31、nhance 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 The following documents, in
32、 whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 60584-1:2013, Thermocouples Par
33、t 1: EMF specifications and tolerances (IEC 60584-1:2013) EN 60751:2008, Industrial platinum resistance thermometers and platinum temperature sensors (IEC 60751:2008) EN ISO 14644-3:2005, Cleanrooms and associated controlled environments Part 3: Test methods (ISO 14644-3:2005) 3 Terms and definition
34、s For the purposes of this document the following terms and definitions apply. 3.1 drying function additional feature of a storage cabinet carried out in the sequence as regulated by the automatic controller to remove moisture 3.2 drying phase part of the storage cycle that is dedicated to the dryin
35、g of the endoscope 3.3 drying temperature band range of temperatures expressed as the minimum and the maximum controlled temperatures, which may prevail throughout the load during drying EN 16442:2015 (E) DIN EN 16442:2015-05 6 3.4 endoscope storage cabinet connector ESC connector device used to con
36、nect 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
37、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
38、 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 te
39、mperatures 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 spe
40、cified in ISO 15883-1 is 65C. 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 deteriora
41、tion 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 a
42、n 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 cabinet
43、s meet the specified requirements. 4.1.2 Detailed requirements for information to be provided by the manufacturer are specified in Clause 8. EN 16442:2015 (E) DIN EN 16442:2015-05 7 4.1.3 The value of any process variable shall be pre-set and adjustment shall require the use of a key, code or tool.
44、4.1.4 Throughout the drying phase and/or storage the values and rate of change in temperature, pressure or any other process variable shall be within limits which will not cause damage to the device(s) stored in the storage cabinet. 4.2 Storage 4.2.1 The storage cabinet shall maintain the microbiolo
45、gical quality of the endoscopes during storage. Tests shall be performed according to Annex E. 4.2.2 A risk analysis with consideration of the different parameters on the storage cabinet performance shall be performed and the means used to minimize the identified risks shall be verified (see 6.1). N
46、OTE 1 According to the design of the storage cabinet those parameters can include: potential for contamination between different endoscopes stored simultaneously (see Annex B); ingress of contamination during loading and/or unloading; potential for contamination caused by accessories and connectors/
47、connections (see Annex B); potential for contamination caused by endoscopes accessories; environmental conditions (e.g. temperature, humidity, etc.) where the storage cabinet is installed; potential for contamination caused by improper air quality in the storage compartment; potential for contamination caused by inefficient drying procedure prior to st
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