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

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

4、ugh a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA administers the process and establishes rules to promote fairness

5、in achieving consensus, it does not independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warrantie

6、s or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringement of any third partys intellectual property rights. CSA does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA mak

7、es no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENT

8、AL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THE

9、ORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA is not undertaking to render professional or oth

10、er services for or on behalf of any person or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility w

11、hatsoever arising in any way from any and all use of or reliance on the information contained in this document. CSA is a private not-for-profit company that publishes voluntary standards and related documents. CSA has no power, nor does it undertake, to enforce compliance with the contents of the st

12、andards or other documents it publishes. Intellectual property rights and ownershipAs between CSA and the users of this document (whether it be in printed or electronic form), CSA is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks

13、 (except as otherwise noted to the contrary), and all inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or discl

14、osure of this document may violate laws that protect CSAs and/or others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual proper

15、ty rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determinati

16、on of the validity of any such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA for informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic fo

17、rm:.load this document onto a computer for the sole purpose of reviewing it;.search and browse this document; and.print this document if it is in PDF format. Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA to have such copies, and o

18、nly if this Legal Notice appears on each such copy.In addition, users may not and may not permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do n

19、ot agree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms a

20、nd conditions of this Legal Notice.The Canadian Standards Association (CSA),under whose auspices this National Standard hasbeen produced, was chartered in 1919 andaccredited by the Standards Council of Canadato the National Standards system in 1973. It is anot-for-profit, nonstatutory, voluntary mem

21、bershipassociation engaged in standards development andcertification activities.CSA standards reflect a national consensus ofproducers and users including manufacturers,consumers, retailers, unions and professionalorganizations, and governmental agencies. Thestandards are used widely by industry and

22、 commerceand often adopted by municipal, provincial, andfederal governments in their regulations, particularlyin the fields of health, safety, building andconstruction, and the environment.Individuals, companies, and associations acrossCanada indicate their support for CSAs standardsdevelopment by v

23、olunteering their time and skillsto CSA Committee work and supporting theAssociations objectives through sustainingmemberships. The more than 7000 committeevolunteers and the 2000 sustaining membershipstogether form CSAs total membership from whichits Directors are chosen. Sustaining membershipsrepr

24、esent a major source of income for CSAsstandards development activities.The Association offers certification and testingservices in support of and as an extension to itsstandards development activities. To ensure theintegrity of its certification process, the Associationregularly and continually aud

25、its and inspects productsthat bear the CSA Mark.In addition to its head office and laboratorycomplex in Toronto, CSA has regional branch officesin major centres across Canada and inspection andtesting agencies in eight countries. Since 1919, theAssociation has developed the necessary expertise tomee

26、t its corporate mission: CSA is an independentservice organization whose mission is to provide anopen and effective forum for activities facilitating theexchange of goods and services through the use ofstandards, certification and related services to meetnational and international needs.For further

27、information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is thecoordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations working towards the fur

28、therdevelopment and improvement of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary standardization as a meansof advancing the national economy, benefiting thehealth, safety, and welfare of the public, assistingand protecting the c

29、onsumer, facilitating domesticand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a standardprepared or reviewed by an accredited StandardsDevelopment Organization (SDO) and approvedby the SCC according to the requirements

30、 of CAN-P-2.Approval does not refer to the technical content of thestandard; this remains the continuing responsibility ofthe SDO. An NSC reflects a consensus of a number ofcapable individuals whose collective interests provide,to the greatest practicable extent, a balance ofrepresentation of genera

31、l interests, producers,regulators, users (including consumers), and otherswith relevant interests, as may be appropriate to thesubject in hand. It normally is a standard which iscapable of making a significant and timely contributionto the national interest.Those who have a need to apply standards a

32、reencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO whichpublishes the standard.The responsibility for approving standards asNational Standards of Canada rests with theStandards Council of Canada270 Albert Stre

33、et, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability for their

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

40、 may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Sta

41、ndard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.csa.caTo purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free 1-800-463-6727 or

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

44、are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incor

45、porated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event tha

46、t a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanica

47、l, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org

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

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