CAN CSA-Z15883-2-2009 Washer-disinfectors - Part 2 Requirements and tests for washerdisinfectors employing thermal disinfection for surgical instruments anaesthetic equipment bowls.pdf

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1、 Reference numberISO 15883-2:2006(E)ISO 2006INTERNATIONAL STANDARD ISO15883-2First edition2006-04-15Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware

2、, etc. Laveurs dsinfecteurs Partie 2: Exigences et essais pour laveurs dsinfecteurs destins la dsinfection thermale des instruments chirurgicaux, du matriel danesthsie, des rcipients, des ustensiles et de la verrerie, etc. National Standard of CanadaCAN/CSA-Z15883-2-09(ISO 15883-2:2006)International

3、 Standard ISO 15883-2:2006 (first edition, 2006-04-15) has been adopted withoutmodification (IDT) as CSA Standard CAN/CSA-Z15883-2-09, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55491-073-1 March 2009 International Organization for Standardi

4、zation (ISO), 2006. All rights reserved.NOT FOR RESALE. Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied vi

5、ewpoints and interests to achieve consensus and develop a standard. Although CSA administers the process and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document i

6、s provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringement of any third partys intel

7、lectual property rights. CSA does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA makes no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLU

8、NTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INT

9、ERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY 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 SU

10、CH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA is not undertaking to render professional or other 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

11、this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility whatsoever 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 t

12、hat publishes voluntary standards and related documents. CSA has no power, nor does it undertake, to enforce compliance with the contents of the standards or other documents it publishes. Intellectual property rights and ownershipAs between CSA and the users of this document (whether it be in printe

13、d or electronic form), CSA is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (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

14、 and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure 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 l

15、egal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual property 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 rig

16、hts. CSA shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA f

17、or informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic form:.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 for

18、mat. 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 only 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

19、Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do not 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 he

20、reof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.The Canadian Standards Association (CSA),under whose auspices this National Standard hasbeen produced, was chartered i

21、n 1919 andaccredited by the Standards Council of Canadato the National Standards system in 1973. It is anot-for-profit, nonstatutory, voluntary membershipassociation engaged in standards development andcertification activities.CSA standards reflect a national consensus ofproducers and users includin

22、g manufacturers,consumers, retailers, unions and professionalorganizations, and governmental agencies. Thestandards are used widely by industry and commerceand often adopted by municipal, provincial, andfederal governments in their regulations, particularlyin the fields of health, safety, building a

23、ndconstruction, and the environment.Individuals, companies, and associations acrossCanada indicate their support for CSAs standardsdevelopment by volunteering their time and skillsto CSA Committee work and supporting theAssociations objectives through sustainingmemberships. The more than 7000 commit

24、teevolunteers and the 2000 sustaining membershipstogether form CSAs total membership from whichits Directors are chosen. Sustaining membershipsrepresent a major source of income for CSAsstandards development activities.The Association offers certification and testingservices in support of and as an

25、extension to itsstandards development activities. To ensure theintegrity of its certification process, the Associationregularly and continually audits and inspects productsthat bear the CSA Mark.In addition to its head office and laboratorycomplex in Toronto, CSA has regional branch officesin major

26、centres across Canada and inspection andtesting agencies in eight countries. Since 1919, theAssociation has developed the necessary expertise tomeet its corporate mission: CSA is an independentservice organization whose mission is to provide anopen and effective forum for activities facilitating the

27、exchange of goods and services through the use ofstandards, certification and related services to meetnational and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council o

28、f Canada (SCC) is thecoordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations working towards the furtherdevelopment and improvement of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary

29、standardization as a meansof advancing the national economy, benefiting thehealth, safety, and welfare of the public, assistingand protecting the consumer, facilitating domesticand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (N

30、SC) is a standardprepared or reviewed by an accredited StandardsDevelopment Organization (SDO) and approvedby the SCC according to the requirements 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 cons

31、ensus of a number ofcapable individuals whose collective interests provide,to the greatest practicable extent, a balance ofrepresentation of general interests, producers,regulators, users (including consumers), and otherswith relevant interests, as may be appropriate to thesubject in hand. It normal

32、ly is a standard which iscapable of making a significant and timely contributionto the national interest.Those who have a need to apply standards areencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO whichpublis

33、hes the standard.The responsibility for approving standards asNational Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application

34、 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 particular purpose.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in

35、March 2009 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z15883-2-09Washer-disinfectors Part 2: Requirements and tests for washe

36、r-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.Registered trade-mark of Canadian Standards AssociationReviewed byPrepared byInternational Organization for StandardizationCAN/CSA-Z15883-2-09Washer-disin

37、fectors Part 2: Requirements and tests for washer-disinfectorsemploying thermal disinfection for surgical instruments, anaestheticequipment, bowls, dishes, receivers, utensils, glassware, etc.March 2009 Canadian Standards Association CSA/3CAN/CSA-Z15883-2-09Washer-disinfectors Part 2: Requirements a

38、nd tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.CSA PrefaceThis is the first edition of CAN/CSA-Z15883-2, Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors emp

39、loying thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc., which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-2 (first edition, 2006-04-15). Thi

40、s Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic 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 Ca

41、nada by the Standards Council of Canada.March 2009 Canadian Standards Association 2009All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this Internationa

42、l Standard” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.c

43、sa.caTo purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free 1-800-463-6727 or 416-747-4044.Reference numberISO 15883-2:2006(E)ISO 2006INTERNATIONAL STANDARD ISO15883-2First edition2006-04-15Washer-disinfectors Part 2: Requirements and tests fo

44、r washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. Laveurs dsinfecteurs Partie 2: Exigences et essais pour laveurs dsinfecteurs destins la dsinfection thermale des instruments chirurgicaux, du matr

45、iel danesthsie, des rcipients, des ustensiles et de la verrerie, etc. ISO 15883-2:2006(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 are embedded are li

46、censed 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 Incorporated. Details of

47、 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 that a problem relatin

48、g to it is found, please inform the Central Secretariat at the address given below. ISO 2006 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 mechanical, including photocopying and microfilm, without

49、 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 ii ISO 2006 All rights reservedCAN/CSA-Z15883-2-09ISO 15883-2:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Performance requirements 2 4.1 General. 2 4.2 Cleaning. 3

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