CAN CSA-Z15883-2009 Washer-disinfectors - Part 4 Requirements and tests for washerdisinfectors employing chemical disinfection for thermolabile endoscopes (First Edition).pdf

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1、 Reference numberISO 15883-4:2008(E)ISO 2008INTERNATIONAL STANDARD ISO15883-4First edition2008-05-01Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesLaveurs dsinfecteurs Partie 4: Exigences et essais pour les laveur

2、s dsinfecteurs destins la dsinfection chimique des endoscopes thermolabiles National Standard of CanadaCAN/CSA-Z15883-4-09(ISO 15883-4:2008)International Standard ISO 15883-4:2008 (first edition, 2008-05-01) has been adopted withoutmodification (IDT) as CSA Standard CAN/CSA-Z15883-4-09, which has be

3、en approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55491-119-6 March 2009 International Organization for Standardization (ISO), 2008. All rights reserved.NOT FOR RESALE. Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed thro

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34、 particular purpose.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in March 2009 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada

35、L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z15883-4-09Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesRegistered trade-mark of Canadian Standards AssociationReviewed byPrepare

36、d byInternational Organization for StandardizationCAN/CSA-Z15883-4-09Washer-disinfectors Part 4: Requirements and tests for washer-disinfectorsemploying chemical disinfection for thermolabile endoscopesMarch 2009 Canadian Standards Association CSA/3CAN/CSA-Z15883-4-09Washer-disinfectors Part 4: Requ

37、irements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesCSA PrefaceThis is the first edition of CAN/CSA-Z15883-4, Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes, whic

38、h is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-4 (first edition, 2008-05-01). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic

39、 Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.March 2009 Canadian Standards Association 2009All rights reserved. No part of this publication

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42、 416-747-4044.Reference numberISO 15883-4:2008(E)ISO 2008INTERNATIONAL STANDARD ISO15883-4First edition2008-05-01Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesLaveurs dsinfecteurs Partie 4: Exigences et essais po

43、ur les laveurs dsinfecteurs destins la dsinfection chimique des endoscopes thermolabiles ISO 15883-4:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which

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48、 ii ISO 2008 All rights reservedCAN/CSA-Z15883-4-09ISO 15883-4:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Performance requirements 3 4.1 General. 3 4.2 Systems for leak testing 4 4.3 Cleaning

49、. 6 4.4 Disinfecting . 7 4.5 Final (post-disinfection) rinsing 9 4.6 Purging to remove rinse water 9 4.7 Drying. 9 4.8 Self-disinfection 10 4.9 Water treatment equipment . 11 5 Mechanical and process requirements 12 5.1 Materials Design, manufacture and construction. 12 5.2 Device channel irrigation system 12 5.3 Venting and drainage systems 13 5.4 Temperature control. 14 5.5 Process chemicals 14 5.6 Process verification 14 5.7 Dosing systems 14 6 Testing for conformity 14 6.1 General. 14 6.2 Test equipment . 15 6.3 Water