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    CAN CSA-C22 2 NO 60601-2-44-2010 Medical electrical equipment - Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipment for computed tom.pdf

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    CAN CSA-C22 2 NO 60601-2-44-2010 Medical electrical equipment - Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipment for computed tom.pdf

    1、Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomographyAppareils lectromdicaux Partie 2-44 : Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement X d

    2、e tomodensitomtrieCAN/CSA-C22.2 No. 60601-2-44-10(IEC 60601-2-44:2009, IDT)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Corrigendum 1Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance

    3、 of X-ray equipment for computed tomographyCorrigendum 1Appareils lectromdicaux Partie 2-44 : Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement X de tomodensitomtrieCorrigendum 1:2011 (IDT) to National Standard of CanadaCorrigendum 1:2011 (IDT)

    4、 la Norme nationale du CanadaCAN/CSA-C22.2 No. 60601-2-44-10(IEC 60601-2-44:2009, IDT)NOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.CSA Standards Update ServiceCorrigendum 1:2011 toCAN/CSA-C22.2 No. 60601-2-44-10June 2011Title: Medical electrical equipment Part 2-44: Particular requirements for

    5、the basic safety and essential performance of X-ray equipment for computed tomographyPagination: 2 pagesTo register for e-mail notification about any updates to this publicationgo to www.ShopCSA.caclick on E-mail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will

    6、 need to register for updates to this publication is 2420265.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs policy on privacy at www.csagroup.org/legal to find out how we protect your personal information.Service de mise jour desnormesCSACorrigendum 1:2011

    7、 laCAN/CSA-C22.2 n 60601-2-44-10Juin 2011Titre : Appareils lectromdicaux Partie 2-44 : Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement X de tomodensitomtrieNombre de pages : 2 pagesVous devez vous inscrire pour recevoir les avis transmis par

    8、courriel au sujet des mises jour apportes ce document :allez au www.ShopCSA.cacliquez sur Services par courriel en dessous de MON COMPTEcliquez sur Service de mise jour des normes CSA Le numro didentification dont vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 24

    9、20265.Si vous avez besoin daide, veuillez nous contacter par courriel au techsupportcsa.ca ou par tlphone au 416-747-2233.Consultez la politique de la CSA en matire de confidentialit au www.csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.May 2010 Mai 2010 IEC 6060

    10、1-2-44 (Third edition 2009) Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CEI 60601-2-44 (Troisime dition 2009) Appareils lectromdicaux Partie 2-44: Exigences particulires pour la scurit de ba

    11、se et les performances essentielles des quipements rayonnement X de tomodensitomtrie CORRIGENDUM 1 CONTENTS In the list of annexes, instead of: “Annex A” and “Annex B” read: “Annex AA” and “Annex BB” SOMMAIRE Dans la liste des annexes, au lieu de: Annexe A et Annexe B lire : Annexe AA et Annexe BB 2

    12、01.7.9.101 Reference to ACCOMPANYING DOCUMENTS In the 21stdashed item, instead of: Protection against STRAY RADIATION 203.13.101 read: Protection against STRAY RADIATION 203.13.2 201.7.9.101 Rfrence aux DOCUMENTS DACCOMPAGNEMENT Au 21metiret, au lieu de: Protection contre les RAYONNEMENTS PARASITES

    13、203.13.101 lire: Protection contre les RAYONNEMENTS PARASITES 203.13.2 203.5.2.4.1 General requirements for RADIATION dose information In the 2nddash, instead of: subclause 203.13.101 (Statements in the ACCOMPANYING DOCUMENTS) is fulfilled. read: subclause 203.13.2 (Statements in the ACCOMPANYING DO

    14、CUMENTS) is fulfilled. 203.5.2.4.1 Exigences gnrales concernant les informations de dose de RAYONNEMENT Au 2metiret, au lieu de: paragraphe 203.13.101 (Indications dans les DOCUMENTS DACCOMPAGNEMENT) est satisfait. Iire: paragraphe 203.13.2 (Indications dans les DOCUMENTS DACCOMPAGNEMENT) est satisf

    15、ait. Corrigendum 1:2011 to CAN/CSA-C22.2 No. 60601-2-44-10May 2010 Mai 2010 203.11 Protection against RESIDUAL RADIATION In the second line of the replacement, instead of: “.203.13.101.” read: “203.13.2.” 203.11 Protection contre le RAYONNEMENT RSIDUEL Dans la deuxime ligne du remplacement, au lieu

    16、de: “.203.13.101” lire: “.203.13.2” Annex A Choosing LOADING FACTORS for tests In the title, instead of: Annex A read: Annex AA Annexe A Choix des PARAMTRES DE CHARGE pour les essais Dans le titre, au lieu de: Annexe A lire: Annexe AA Annex B Estimating CTDIvolfor scan projection RADIOGRAPHY (SPR) I

    17、n the title, instead of: Annex B read: Annex BB Annexe B Estimation de CTDIvolpour la RADIOGRAPHIE par projection (SPR, scan projection radiography) Dans le titre, au lieu de: Annexe B lire: Annexe BB Corrigendum 1:2011 to CAN/CSA-C22.2 No. 60601-2-44-10ICS 11.040.50 Copyright NoticeThis Amendment t

    18、o the International Standard contains information copyright protected by the International Electrotechnical Commission (IEC). Except as permitted under the laws of Canada, no extract of this Amendment to the International Standard may be reproduced, stored in any retrieval system, or transmitted in

    19、any form or by any means, electronic, photocopying, recording, or otherwise, without prior permission from the Standards Council of Canada (SCC). Requests for permission to reproduce this Amendment to the International Standard or parts thereof should be addressed to Manager, Technical Document Cent

    20、re Standards Council of Canada 270 Albert Street, Suite 200 Ottawa, Ontario K1P 6N7 The Canadian adoption of this Amendment to the International Standard contains information copyright protected by the Canadian Standards Association. All rights reserved. No part of this adopted Amendment may be repr

    21、oduced in any form whatsoever without the prior permission of the publisher. IEC material is reprinted with permission. Requests for permission to reproduce this adopted Amendment or parts thereof should be addressed to Manager, Sales Canadian Standards Association 5060 Spectrum Way, Suite 100 Missi

    22、ssauga, Ontario L4W 5N6Copyright violators will be prosecuted to the full extent of the law. Avis de droits dauteur Cet amendement la Norme internationale contient des renseignements qui sont la proprit de la Commission lectrotechnique Internationale (CEI) et qui sont protgs par des droits dauteur.

    23、Sous rserve de ce qui est permis par les lois du Canada, aucune partie de cet amendement la Norme internationale ne peut tre reproduite, conserve dans un systme dextraction ou transmise dans quelque format que ce soit et par quelque moyen que ce soit, lectronique, photocopie, enregistrement ou autre

    24、, sans la permission pralable du Conseil canadien des normes (CCN). Les demandes dautorisation de reproduction de cet amendement la Norme internationale ou de parties de cet amendement devraient tre adresses : Chef, Centre de documentation technique Conseil canadien des normes 270, rue Albert, burea

    25、u 200 Ottawa (Ontario) K1P 6N7 Cette modification adopte par le Canada contient des renseignements qui sont la proprit de lAssociation canadienne de normalisation et qui sont protgs par les droits dauteur. Tous droits rservs. Aucune partie de cette modification adopte ne peut tre reproduite par quel

    26、que moyen que ce soit sans la permission pralable de lorganisme qui la publie. Le matriel appartenant la CEI est reproduit avec la permission de la CEI. Les demandes dautorisation de reproduction de cette modification adopte ou de parties de cette modification devraient tre adresses : Chef, Ventes A

    27、ssociation canadienne de normalisation 5060, Spectrum Way, bureau 100 Mississauga (Ontario) L4W 5N6 Toute personne qui se rend coupable dune infraction lgard du droit dauteur sera poursuivie dans toute la mesure permise par la loi. PRINTED IN CANADAIMPRIMEAU CANADA100%The Canadian Standards Associat

    28、ion (CSA) prints its publications on Rolland Enviro100, which contains 100% recycled post-consumer fibre, is EcoLogo and Processed Chlorine Free certified, and was manufactured using biogas energy.LAssociation canadienne de normalisation (CSA) imprime ses documents sur du papier Rolland Enviro100. I

    29、l sagit dun papier homologu co-Logo qui a t fabriqu 100 % avec des fibres postconsommation par un processus aliment au biogaz et trait selon un procd certifi sans chlore.CSA Standards Update ServiceCAN/CSA-C22.2 No. 60601-2-44-10January 2010Title: Medical electrical equipment Part 2-44: Particular r

    30、equirements for the basic safety and essential performance of X-ray equipment for computed tomographyPagination: 103 pages (CSA/1CSA/13 and 90 text)To register for e-mail notification about any updates to this publicationgo to www.ShopCSA.caclick on E-mail Services under MY ACCOUNTclick on CSA Stand

    31、ards Update ServiceThe List ID that you will need to register for updates to this publication is 2420265.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs policy on privacy at www.csagroup.org/legal to find out how we protect your personal information.Service

    32、 de mise jour desnormesCSACAN/CSA-C22.2 n 60601-2-44-10Janvier 2010Titre : Appareils lectromdicaux Partie 2-44 : Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement X de tomodensitomtrieNombre de pages : 103 pages (CSA/1 CSA/13 et 90 pages de tex

    33、te)Vous devez vous inscrire pour recevoir les avis transmis par courriel au sujet des mises jour apportes ce document :allez au www.ShopCSA.cacliquez sur Services par courriel en dessous de MON COMPTEcliquez sur Service de mise jour des normes CSA Le numro didentification dont vous avez besoin pour

    34、vous inscrire pour les mises jour apportes ce document est le 2420265.Si vous avez besoin daide, veuillez nous contacter par courriel au techsupportcsa.ca ou par tlphone au 416-747-2233.Consultez la politique du CSA en matire de confidentialit au www.csagroup.org/legal pour savoir comment nous protg

    35、eons vos renseignements personnels.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 viewpoints and interest

    36、s 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 is provided without an

    37、y 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 intellectual property righ

    38、ts. 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 VOLUNTEERS, MEMBERS, SUBS

    39、IDIARIES, 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 INTERRUPTION, LOST OR DA

    40、MAGED 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 SUCH DAMAGES, INJURY, L

    41、OSS, 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 this document is dire

    42、cted 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 that publishes volunta

    43、ry 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 printed or electronic form)

    44、, 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 and trade secrets ar

    45、e 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 legal redress for such

    46、 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 rights. CSA shall not be

    47、 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 for informational and

    48、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 format. Limited copies o

    49、f 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 Legal Notice from the att


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