DIN EN ISO 15883-7-2016 Washer-disinfectors - Part 7 Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive non-critical thermolabile medic.pdf

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1、October 2016 English price group 19No 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 11.080.10!%n“2577529www.din.deDI

2、N EN ISO 15883-7Washerdisinfectors Part 7: Requirements and tests for washerdisinfectors employing chemical disinfection for noninvasive, noncritical thermolabile medical devices and healthcare equipment (ISO 158837:2016);English version EN ISO 158837:2016,English translation of DIN EN ISO 15883-7:2

3、016-10ReinigungsDesinfektionsgerte Teil 7: Anforderungen und Prfverfahren fr ReinigungsDesinfektionsgerte mit chemischer Desinfektion fr nicht invasive, nicht kritische thermolabile Medizinprodukte und Zubehr imGesundheitswesen (ISO 158837:2016);Englische Fassung EN ISO 158837:2016,Englische bersetz

4、ung von DIN EN ISO 15883-7:2016-10Laveurs dsinfecteurs Partie 7: Exigences et essais pour les laveurs dsinfecteurs destins la dsinfection chimiquedes dispositifs mdicaux thermosensibles, non invasifs et non critiques et des quipements desoins de sant (ISO 158837:2016);Version anglaise EN ISO 158837:

5、2016,Traduction anglaise de DIN EN ISO 15883-7:2016-10Supersedes DIN 589551:200301, DIN 589552:200507, DIN 589553:199809, DIN 589554:200603, DIN 589556:200103 and DIN 589557:200103Supersedes: see belowwww.beuth.deDocument comprises 48 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the Ger

6、man-language original shall be considered authoritative.10.16 DIN EN ISO 15883-7:2016-10 2 A comma is used as the decimal marker. National foreword This document (EN ISO 15883-7:2016) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Te

7、chnical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-09 AA Reinigungs-Desinfektionsgerte. DIN EN ISO 15883 c

8、onsists 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 disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers,

9、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 disinfection for thermolabile endoscopes Part 5: Test soils and methods for demonstrati

10、ng cleaning efficacy Technical Specification Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-in

11、vasive, non-critical thermolabile medical devices and healthcare equipment The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 11737-1 DIN EN ISO 11737-1 ISO 15883-1 DIN EN ISO 15883-1 ISO 15883-2 DIN EN ISO 15883-2 ISO 15883-3 DIN EN ISO 1

12、5883-3 ISO 15883-4 DIN EN ISO 15883-4 ISO/TS 15883-5 DIN ISO/TS 15883-5 IEC 61010-2-040 DIN EN 61010-2-040 (VDE 0411-2-040) DIN EN ISO 15883-7:2016-10 3 Amendments This standard differs from DIN 58955-1:2003-01, DIN 58955-2:2005-07, DIN 58955-3:1998-09, DIN 58955-4:2006-03, DIN 58955-6:2001-03 and D

13、IN 58955-7:2001-03 as follows: a) the DIN 58955 series of standards dealing with decontamination equipment for medical use served as a basis for the new standards project at CEN and ISO; the DIN EN ISO 15883 standards series has been taken as the basis for the document structure; b) terms and defini

14、tions of DIN 58955-1 have been brought in line with DIN EN ISO 15883-1 and ISO/TS 11139; c) requirements for devices, equipment and test methods have been substantially adopted from the DIN 58955 series of standards, but partly increased (see e.g. thermal methods); d) the requirements for devices an

15、d equipment formerly given in DIN 58955-2 are now specified in Clauses 5 and 6 and via reference to DIN EN ISO 15883-1, specific material requirements having been dispensed with to avoid design limitations; e) performance requirements formerly given in DIN 58955-3 are now specified in Clause 4, Subc

16、lauses 6.7 and 6.8 (see also Annex A), and via reference to DIN EN ISO 15883-1; f) requirements for biological indicators formerly given in DIN 58955-4 are now specified primarily in Annexes B to E; g) requirements for operation (commissioning/maintenance) formerly given in DIN 58955-6 and for servi

17、ces supply formerly given in DIN 58955-7 are now specified primarily in Clause 4 and via reference to DIN EN ISO 15883-1; h) the standard has been prepared under a mandate (see Annex ZA). Previous editions DIN 58955-1: 1992-09, 2003-01 DIN 58955-2: 1998-09, 2005-07 DIN 58955-3: 1998-09 DIN 58955-4:

18、1998-09, 2006-03 DIN 58955-6: 2001-03 DIN 58955-7: 2001-03 DIN EN ISO 15883-7:2016-10 4 National Annex NA (informative) Bibliography DIN EN ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products DIN EN ISO 15883-1, Wa

19、sher-disinfectors Part 1: General requirements, terms and definitions and tests DIN EN ISO 15883-2, Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware

20、, etc. DIN EN ISO 15883-3, Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers DIN EN ISO 15883-4, Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolab

21、ile endoscopes DIN ISO/TS 15883-5, Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy 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

22、 and washer-disinfectors used to treat medical materials EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15883-7 March 2016 ICS 11.080.10 English Version Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critic

23、al thermolabile medical devices and healthcare equipment (ISO 15883-7:2016) Laveurs dsinfecteurs - Partie 7: Exigences et essais pour les laveurs dsinfecteurs utilisant la dsinfection chimique pour les dispositifs mdicaux et les quipements de soins thermosensibles non invasifs et non critiques (ISO

24、15883-7:2016) Reinigungs-Desinfektionsgerte - Teil 7: Anforderungen und Prfverfahren fr Reinigungs-Desinfektionsgerte mit chemischer Desinfektion fr nicht invasive, nicht kritische thermolabile Medizinprodukte und Zubehr im Gesundheitswesen (ISO 15883-7:2016) This European Standard was approved by C

25、EN on 8 February 2016. 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 standar

26、ds 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 noti

27、fied 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, Ic

28、eland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, 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 Man

29、agement Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15883-7:2016 EEuropean foreword.4Introduction 141 Scope 152 Normative references . 153 Terms and definitions 164 Performance

30、 requirements 164.1 General 164.2 Cleaning 174.3 Disinfection . 174.4 Final rinsing 194.5 Self-disinfection 194.6 Drying 204.7 Water treatment equipment. 204.7.1 General. 204.7.2 Disinfection of water treatment equipment 204.7.3 Maintenance of piping 215 Mechanical requirements 215.1 Materials Desig

31、n, manufacture, and assembly 215.2 Process verification 216 Testing for conformity . 216.1 General 216.2 Test load . 226.2.1 Loading with standard goods 226.2.2 Loading with special goods . 226.3 Water used for rinsing following disinfection . 226.4 Load dryness 226.4.1 General. 226.4.2 Procedure 22

32、6.4.3 Results 226.5 Thermometric tests . 226.5.1 General. 226.5.2 Load temperature test 226.6 Chemical dosing tests . 236.6.1 General. 236.6.2 Reused process chemicals 236.7 Tests of cleaning efficacy . 236.7.1 General. 236.7.2 Materials 236.7.3 Procedure 246.7.4 Results 246.8 Test of disinfection e

33、fficacy . 246.8.1 General. 246.8.2 Preliminary tests on chemical disinfectants .246.8.3 Self-disinfection tests 256.8.4 Chemical disinfection of the load26Contents PageAnnex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 ai

34、med to be covered 6 Foreword 13.2DIN EN ISO 15883-7:2016-10 EN ISO 15883-7:2016 (E)Annex B (normative) Methods for microbiological evaluation of disinfection of liquid transport system30Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water .35Annex D (normative

35、) Preparation and evaluation of indicators for microbiological testing of the efficacy of chemical disinfection of the load 37Annex E (informative) Examples of test locations for the tests with biological indicators 40Bibliography .447 Documentation 268 Information to be provided by the manufacturer

36、 .269 Marking, labelling, and packaging 2710 Information to be requested from the purchaser by the manufacturer 27Annex A (normative) Summary of test programmes 283DIN EN ISO 15883-7:2016-10 EN ISO 15883-7:2016 (E) European foreword This document (EN ISO 15883-7:2016) has been prepared by Technical

37、Committee ISO/TC 198 “Sterilization of health care products” in collaboration with 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

38、 text or by endorsement, at the latest by September 2016, and conflicting national standards shall be withdrawn at the latest by September 2016. 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

39、responsible for identifying any or all such patent rights. 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 EU Directive(s). For relationship with EU Directive(s), see informative A

40、nnex ZA, which is an integral part of this document. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited appli

41、es. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in th

42、e ISO standard text, this should be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the e

43、xtent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 11737-1 EN ISO 11737-1:2006 + EN ISO 11737-1:2006/AC:2009 ISO 11737-1:200

44、6 + ISO 11737-1:2006/Cor 1:2007 ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009 ISO 15883-1 EN ISO 15883-1:2009 + EN ISO 15883-1:2009/A1:2014 ISO 15883-1:2006 + ISO 15883-1:2006/Amd1:2014 ISO 15883-2 EN ISO 15883-2:2009 ISO 15883-2:2006 ISO 15883-3 EN ISO 15883-3:2009 ISO 15883-3:2006 ISO 15883-4 E

45、N ISO 15883-4:2009 ISO 15883-4:2008 ISO 15883-6 EN ISO 15883-6:2015 ISO 15883-6:2011 ISO/TS 15883-5 CEN ISO/TS 15883-5:2005 ISO/TS 15883-5:2005 IEC 610102-040 EN 61010-2-040:2005 IEC 61010-2-040:2005 4DIN EN ISO 15883-7:2016-10 EN ISO 15883-7:2016 (E)According to the CEN-CENELEC Internal Regulations

46、, 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, L

47、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15883-7:2016 has been approved by CEN as EN ISO 15883-7:2016 without any modification. 5DIN EN ISO 15

48、883-7:2016-10 EN ISO 15883-7:2016 (E) Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 concerning the develo

49、pment of European standards to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the