CAN CSA-Z15883-1-2009 Washer-disinfectors - Part 1 General requirements terms and definitions and tests (First Edition Update No 1 September 2009).pdf

《CAN CSA-Z15883-1-2009 Washer-disinfectors - Part 1 General requirements terms and definitions and tests (First Edition Update No 1 September 2009).pdf》由会员分享，可在线阅读，更多相关《CAN CSA-Z15883-1-2009 Washer-disinfectors - Part 1 General requirements terms and definitions and tests (First Edition Update No 1 September 2009).pdf（92页珍藏版）》请在麦多课文档分享上搜索。

1、 Reference numberISO 15883-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO15883-1First edition2006-04-15Washer-disinfectors Part 1: General requirements, terms and definitions and tests Laveurs dsinfecteurs Partie 1: Exigences gnrales, termes et dfinitions et essais National Standard of CanadaCAN/CSA-Z1

2、5883-1-09International Standard ISO 15883-1:2006 (first edition, 2006-04-15) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z15883-1-09, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55491-074-8 March 2009 International

3、Organization for Standardization (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 volunte

4、ers representing varied viewpoints 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 o

5、f liabilityThis document is 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

6、 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 makes no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO

7、 EVENT SHALL CSA, ITS VOLUNTEERS, 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,

8、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 THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISE

9、D 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 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 e

10、ntity. 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 whatsoever arising in any way from any and all use of or reliance on the information contained in this document. CSA is a privat

11、e 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 standards or other documents it publishes. Intellectual property rights and ownershipAs between CSA and the users of this documen

12、t (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 (except as otherwise noted to the contrary), and all inventions and trade secrets that may be contained in this document, whet

13、her or not such inventions 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 C

14、SA 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 property rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be

15、 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 determination of the validity of any such patent rights is entirely their own responsibility.Authorized use of this documentThis document

16、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 form:.load this document onto a computer for the sole purpose of reviewing it;.search and browse this document; and.print this do

17、cument 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 only if this Legal Notice appears on each such copy.In addition, users may not and may not permit others to.alter this document

18、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 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

19、 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 and conditions of this Legal Notice.Update No. 1CAN/CSA-Z15883-1-09September 2009Note: General Instructions for CSA Standards ar

20、e now called Updates. Please contact CSA Information Products Sales or visit www.ShopCSA.ca for information about the CSA Standards Update Service.Title: Washer-disinfectors Part 1: General requirements, terms and definitions and tests originally published March 2009The following revisions have been

21、 formally approved and are marked by the symbol delta () in the margin on the attached replacement pages: Update your copy by inserting these revised pages.Keep the pages you remove for reference.Revised Canadian deviation to Table B.1New NoneDeleted NoneCAN/CSA-Z15883-1-09Washer-disinfectors Part 1

22、: General requirements, terms and definitions and testsSeptember 20096.4.1 GeneralAdd the following to the first paragraphRefer to AAMI TIR34 for guidance on water testing and water quality for washer-disinfectors.6.10.1 GeneralAdd the following noteNote 1A: The test methods and soils specified in I

23、SO/TS 15883-5 are based on national practices in several ISO member countries other than Canada. Canadian users should employ qualified testing services when available through a contracted third party. As a supplement to this testing, or if qualified testing services are not available, commercially

24、available indicators should be regularly used to verify cleaning efficacy.6.11.1 ProcedureAdd the following noteNote 1A: The tests specified in ISO/TS 14644-3 are based on national practices in several ISO member countries other than Canada. As such, these tests of air quality are not available in C

25、anada.Annex A (informative)Test programmeAdd the following to the first paragraph below Figure A.1The testing programme outlined in Table A.1 is a useful reference, but it should be adapted in consultation with the manufacturer or manufacturer-designate to align with this Standard (including the Can

26、adian deviations).Annex B (informative)A0 concept Comparative lethality of moist heat processesAdd the following note below Table B.1Note 1A: The A0 concept is not yet widely used in Canada. In general, the following equivalencies can help users to understand how A0values relate to existing decontam

27、ination and sterilization processes:a) An A0= 60 (i.e., 1 min at 80 C) can be considered equivalent to thermal conditions that would render a device safe to handle or for contact with intact skin. b) An A0= 600 (i.e., 1 min at 90 C) can be considered equivalent to thermal conditions that achieve pas

28、teurization, i.e., rendering a device safe for contact with mucous membranes.c) An A0= 3000 (i.e., 10 min at 90 C) can be considered equivalent to thermal conditions for complete microbial kill. Devices exposed to these thermal conditions should not be used in procedures where sterility is required.

29、CSA/5(Replaces p. CSA/5, March 2009)Standards Update ServiceCAN/CSA-Z15883-1-09March 2009Title: Washer-disinfectors Part 1: General requirements, terms and definitions and testsPagination: 81 pages (CSA/1CSA/5, ivi, and 70 text)To register for e-mail notification about any updates to this publicatio

30、ngo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2419595.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect

31、 your personal information.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 membershipa

32、ssociation 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 commerc

33、eand 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 volunteer

34、ing 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 membershipsrepresent a

35、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 audits and

36、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 tomeet its co

37、rporate 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 informat

38、ion 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 furtherdeve

39、lopment 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 consumer,

40、 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 of CAN-

41、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 general intere

42、sts, 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 areencour

43、aged 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 Street, Suit

44、e 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 particu

45、lar 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 L4W 5N61

46、-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z15883-1-09Washer-disinfectors Part 1: General requirements, terms and definitions and testsRegistered trade-mark of Canadian Standards AssociationReviewed byPrepared byInternational Organization for StandardizationCAN/CSA-Z15

47、883-1-09Washer-disinfectors Part 1: Generalrequirements, terms and definitions and testsMarch 2009 Canadian Standards Association CSA/3CAN/CSA-Z15883-1-09Washer-disinfectors Part 1: General requirements, terms and definitions and testsCSA PrefaceThis is the first edition of CAN/CSA-Z15883-1, Washer-

48、disinfectors Part 1: General requirements, terms and definitions and tests, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 15883-1 (first edition, 2006-04-15). This Standard was reviewed for Canadian adoption by

49、 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 Canada 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 wo