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

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

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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

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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