EN 16442-2015 en Controlled environment storage cabinet for processed thermolabile endoscopes《放置加工感热内窥镜的受控环境存储柜》.pdf

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1、BSI Standards PublicationBS EN 16442:2015Controlled environmentstorage cabinet for processedthermolabile endoscopesBS EN 16442:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16442:2015. The UK participation in its preparation was entrusted to TechnicalComm

2、ittee 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 applicat

3、ion. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 75809 6 ICS 11.140 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

4、 on 31 March 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16442 March 2015 ICS 11.140 English Version Controlled environment storage cabinet for processed thermolabile endoscopes Enceinte de stockage atmosphre con

5、trle pour endoscopes thermosensibles traits Lagerungschrank mit gergeltn Umgebungsbedingungen fr 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 conditio

6、ns 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

7、 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 standard

8、s 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, Sloven

9、ia, 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 All rights of exploitation in any form and by any means reserved w

10、orldwide for CEN national Members. Ref. No. EN 16442:2015 EBS EN 16442:2015EN 16442:2015 (E) 2 Contents 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

11、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 Automati

12、c 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 con

13、formity 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- chamb

14、er 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

15、 requested from the purchaser by the manufacturer . 25 Annex A (informative) Summary of test programmes . 26 Annex B (informative) Cross-contamination between endoscopes . 28 BS EN 16442:2015EN 16442:2015 (E) 3 Annex C (normative) Methods for evaluation of airborne microbial contamination in the sto

16、rage 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) Establishing endoscope product families 5

17、5 Bibliography . 59 BS EN 16442:2015EN 16442:2015 (E) 4 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, eit

18、her 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

19、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, C

20、zech 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 King

21、dom. BS EN 16442:2015EN 16442:2015 (E) 5 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 p

22、rovided 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 desig

23、ned 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

24、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

25、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. BS EN 16442:2015EN 16442:2015 (E) 6 1 Scope This European

26、 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, an

27、d 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 necess

28、ary, 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 a

29、n 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

30、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 whole or in part, are normatively referenced in

31、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 Part 1: EMF specifications and tolerances (IEC 60584

32、-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 definitions For the purposes of this document the following

33、 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 drying of the endoscope 3.3 drying temperature band ra

34、nge of temperatures expressed as the minimum and the maximum controlled temperatures, which may prevail throughout the load during drying BS EN 16442:2015EN 16442:2015 (E) 7 3.4 endoscope storage cabinet connector ESC connector device used to connect endoscope channels inside the cabinet to the flus

35、hing 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 closure

36、s, 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 qua

37、lity 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 co

38、ntrolled 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 65C. 4 Performance requiremen

39、ts 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.

40、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 prol

41、onged 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 requ

42、irements for information to be provided by the manufacturer are specified in Clause 8. BS EN 16442:2015EN 16442:2015 (E) 8 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. 4.1.4 Throughout the drying phase and/or storage the values

43、 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 microbiological quality of the endoscopes during storage. Tests shall

44、 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). NOTE 1 According to the design of the storage cabinet those

45、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/connections (see Annex B); potential for contamination caus

46、ed 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 storage

47、; potential for growth of the initial contamination of a contaminated endoscope accidentally introduced in the storage cabinet. NOTE 2 EN ISO 14971 establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle and may b

48、e used. 4.2.3 If the storage cabinet does not have a drying phase, it has to be specified that the endoscope (outside surfaces and internal channels) has to be dried before storage see 8.2 j). 4.2.4 Any instructions given by the manufacturer for drying the inside and outside of the endoscope shall c

49、onform to the endoscope manufacturers instructions (on pressure issues, temperature issues, etc.). 4.2.5 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