1、September 2009DEUTSCHE NORM English price group 23No part of this standard 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 11.080.10!$Ya“154622
2、5www.din.deDDIN EN ISO 15883-4Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employingchemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)English version of DIN EN ISO 15883-4:2009-09Reinigungs-Desinfektionsgerte Teil 4: Anforderungen und Prfverfahren fr R
3、einigungs-Desinfektionsgerte mitchemischer Desinfektion fr thermolabile Endoskope (ISO 15883-4:2008)Englische Fassung DIN EN ISO 15883-4:2009-09SupersedesDIN EN ISO 15883-4:2008-08See start of validitywww.beuth.deDocument comprises 61 pagesDIN EN ISO 15883-4:2009-09 2 Start of validity This standard
4、 takes effect on 1 September 2009. DIN EN ISO 15883-4:2008-08 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for
5、 medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-04-09 AA Reinigungs-Desinfektionsgerte. This standard contains specifications meeting the essential requir
6、ements set out in EU Directive 93/42/EEC on medical devices. DIN EN ISO 15883 consists of the following parts under the general title Washer-disinfectors: Part 1: General requirements, terms and definitions and tests Part 2: Requirements and tests for washer-disinfectors employing thermal disinfecti
7、on for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers Part 4: Requirements and tests for washer-disinfectors employing chemical disinfect
8、ion for thermolabile endoscopes Part 5: Test soils and methods for demonstrating cleaning efficacy Technical Specification Part 6: Requirements and tests for general purpose washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (at
9、 present at the stage of draft) The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 384 DIN ISO 384 ISO 11138-1 DIN EN ISO 11138-1 ISO 11731-2 DIN EN ISO 11731-2 IEC 61010-2-040 DIN EN 61010-2-040 (VDE 0411-2-040) Amendments This standard d
10、iffers from DIN EN ISO 15883-4:2008-08 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and
11、of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. DIN EN ISO 15883
12、-4:2009-09 3 Previous editions DIN EN ISO 15883-4: 2008-08 National Annex NA (informative) Bibliography DIN EN 61010-2-040 (VDE 0411-2-040), Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfe
13、ctors used to treat medical materials DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Part 1: General requirements DIN EN ISO 11731-2, Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts
14、DIN ISO 384, Laboratory Glassware Principles of Design and Construction of Volumetric Glassware DIN EN ISO 15883-4:2009-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15883-4 June 2009 ICS 11.080.10 Supersedes EN ISO 15883-4:2008 English Version Washer
15、-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) Laveurs dsinfecteurs - Partie 4: Exigences et essais pour les laveurs dsinfecteurs destins la dsinfection chimique des endoscopes thermolabiles (ISO 1
16、5883-4:2008) Reinigungs-Desinfektionsgerte - Teil 4: Anforderungen und Prfverfahren fr Reinigungs-Desinfektionsgerte mit chemischer Desinfektion fr thermolabile Endoskope (ISO 15883-4:2008) This European Standard was approved by CEN on 16 May 2009. CEN members are bound to comply with the CEN/CENELE
17、C 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 Management Centre or to any C
18、EN 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 Management Centre has the same status as the official versions. CE
19、N members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sw
20、eden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members
21、. Ref. No. EN ISO 15883-4:2009: EContents Page Foreword .4 Introduction.5 1 Scope6 2 Normative references7 3 Terms and definitions .7 4 Performance requirements.8 4.1 General .8 4.2 Systems for leak testing .9 4.3 Cleaning .11 4.4 Disinfecting 12 4.5 Final (post-disinfection) rinsing.14 4.6 Purging
22、to remove rinse water.14 4.7 Drying .14 4.8 Self-disinfection.15 4.9 Water treatment equipment16 5 Mechanical and process requirements.17 5.1 Materials Design, manufacture and construction .17 5.2 Device channel irrigation system 17 5.3 Venting and drainage systems 18 5.4 Temperature control19 5.5 P
23、rocess chemicals 19 5.6 Process verification 19 5.7 Dosing systems.19 6 Testing for conformity 19 6.1 General .19 6.2 Test equipment20 6.3 Water used for final (post-disinfection) rinsing .20 6.4 Hardness of water used during type testing 20 6.5 Leak test .21 6.6 Channels non-obstruction test 23 6.7
24、 Channels non-connection test.24 6.8 Load dryness .25 6.9 Thermometric tests .25 6.10 Chemical dosing tests 26 6.11 Tests of cleaning efficacy.27 6.12 Test of disinfection efficacy .28 7 Documentation and inspection32 8 Information to be supplied by the manufacturer .32 9 Marking, labelling and pack
25、aging33 10 Information to be requested from the purchaser by the manufacturer .33 Annex A (informative) Summary of activities covered by this Part of ISO 15883 34 Annex B (normative) Microbiological testing of the efficacy of chemical disinfection of the load .36 Annex C (informative) Summary of tes
26、t programmes.39 Annex D (normative) Methods for microbiological evaluation of disinfection of liquid transport system 40 2 DIN EN ISO 15883-4:2009-09 EN ISO 15883-4:2009 (E) Annex E (normative) Tests for microbial contamination of post-disinfection rinse water 45 Annex F (informative) Typical specif
27、ications of trumpet valves and connection ports . 46 Annex G (informative) Additional notes on microbiological testing of chemical disinfection processes 51 Bibliography. 53 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC. 5
28、5 3 DIN EN ISO 15883-4:2009-09 EN ISO 15883-4:2009 (E) Foreword The text of ISO 15883-4:2008 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 15883-4:2009 by Techn
29、ical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariatof 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 December 2009, and conflicting national standar
30、ds shall be withdrawn at the latest by March 2010. 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. This document supersedes EN ISO 158
31、83-4:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. A
32、ccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L
33、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15883-4:2008 has been approved by CEN as a EN ISO 15883-4:2009 without any modification. 4 DIN EN ISO 15883-4
34、:2009-09 EN ISO 15883-4:2009 (E) Introduction It is recommended that this introduction be read in conjunction with the introduction to ISO 15883-1. The washer-disinfectors specified in this part of ISO 15883 are intended to process devices which can be immersed in water or aqueous solutions. For som
35、e devices this will require that, prior to processing, relevant parts of the device are protected from immersion in accordance with the device manufacturers operating instructions. Fields of application within the scope of the ISO 15883 series include laboratory, veterinary, dental and pharmaceutica
36、l applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for use with immunologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other pa
37、rts of ISO 15883. Safety requirements for washer-disinfectors are given in IEC 61010-2-040. With respect to the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfectors: a) note that, until verifiable European criteria are adopted, existing n
38、ational regulations concerning the use and/or the characteristics of the washer-disinfectors remain in force; b) this part of ISO 15883 provides no information as to whether the washer-disinfectors may be used without restriction in any of the member states of the EU or EFTA. 5 DIN EN ISO 15883-4:20
39、09-09 EN ISO 15883-4:2009 (E) 1 Scope This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This part of ISO 15883 also specifies the performan
40、ce requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and
41、 performance qualification on first installation), routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this part
42、of ISO 15883. NOTE 2 WDs complying with this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended this method of disinfection. WDs complying with the requirements of this part of IS
43、O 15883 are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006, 4.1.5). The specified performance requirements of this part of ISO 15883 may not ensure th
44、e inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not reac
45、t with the prion protein in a manner that may inhibit its removal or inactivation from the load or washer-disinfector. This part of ISO 15883 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, d
46、isinfecting products, and also by users. 6 DIN EN ISO 15883-4:2009-09 EN ISO 15883-4:2009 (E) 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edi
47、tion of the referenced document (including any amendments) applies. ISO 11731-2, Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts ISO 15883-1:2006, Washer-disinfectors Part 1: General requirements, terms and definiti
48、ons and tests ISO/TS 15883-5:2005, Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy IEC 61010-2-040, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfec
49、tors used to treat medical materials 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following apply. 3.1 air break physical separation in water supply pipes to prevent back syphonage into the water supply from a device connected to it NOTE See EN 1717. 3.2 inoculated carrier supporting material on or in which a defined number of viable test organisms has been deposited ISO 11138-1:2006, definition 3.10 3.3 leak test test intended to establish that the
