1、Medical electrical equipment Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisAppareils lectromdicaux Partie2-33: Exigences particulires pour la scurit de base et les performances essentielles des appareils rsonanc
2、e magntique utiliss pour le diagnostic mdicalCAN/CSA-C22.2 No. 60601-2-33:12(IEC 60601-2-33:2010, IDT)National Standard of CanadaNorme nationale du CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Corrigendum 1Medical electrical equipment Part 2-33: Particular requirements for the basic safet
3、y and essential performance of magnetic resonance equipment for medical diagnosisCorrigendum 1Appareils lectromdicaux Partie 2-33: Exigences particulires pour la scurit de base et les performances essentielles des appareils rsonance magntique utiliss pour le diagnostic mdicalCorrigendum 1:2012 (IDT)
4、 to National Standard of CanadaCorrigendum 1:2012 (IDT) la Norme nationale du CanadaCAN/CSA-C22.2 No. 60601-2-33:12(IEC 60601-2-33:2010, IDT)NOT FOR RESALE. / PUBLICATION NON DESTINE LA REVENTE.Standards Update ServiceCorrigendum 1:2012 toCAN/CSA-C22.2 No. 60601-2-33:12October 2012Title: Medical ele
5、ctrical equipment Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisPagination: 2 pagesTo register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID
6、 that you will need to register for updates to this publication is 2421679.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 your personal information.Service de mise jour des norm
7、esCorrigendum 1:2012 laCAN/CSA-C22.2 n 60601-2-33:12Octobre 2012Titre : Appareils lectromdicaux Partie 2-33: Exigences particulires pour la scurit de base et les performances essentielles des appareils rsonance magntique utiliss pour le diagnostic mdicalNombre de pages : 2 pagesVous devez vous inscr
8、ire pour recevoir les avis transmis par courriel au sujet des mises jour apportes ce document : allez au shop.csa.cacliquez sur Service de mises jour Le numro didentification dont vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 2421679.Si vous avez besoin daide, v
9、euillez nous contacter par courriel au techsupportcsagroup.org ou par tlphone au 416-747-2233.Consultez la politique du Groupe CSA en matire de confidentialit au csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.March 2012 Mars 2012 IEC 60601-2-33 (Third edition 201
10、0) Medical electrical equipment Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis CEI 60601-2-33 (Troisime dition 2010) Appareils lectromdicaux Partie 2-33: Exigences particulires pour la scurit de base et les perf
11、ormances essentielles des appareils rsonance magntique utiliss pour le diagnostic mdical CORRIGENDUM 1 201.3.201 Replace the existing term “B1RMS“ by “B1+RMS“. Replace, in the definition: “B1, the radio frequency magnetic induction“ by “B1+, the MR relevant radiofrequency magnetic induction“ Replace
12、, in the formula, “B1RMS“ by “B1+RMS“ and “B1“ by “B1+“. Table 201.101 List of symbols In the 2ndrow, 1stcolumn replace “B1“ by “B1+“. In the 3rdrow, 1stcolumn replace “B1RMS“ by “B1+RMS“. In the 3rdrow, 3rdcolumn replace “B1“ by “B1+“. 201.7.9.2.101 Instructions for use for MR EQUIPMENT j) Exposure
13、 of the PATIENT to radio frequency magnetic fields In the final dashed item replace “B1RMS“ by “B1+RMS“ 201.3.201 Remplacer le terme existant “B1RMS“ par “B1+RMS“. Remplacer, dans la dfinition: “B1, linduction magntique radiofrquence“ par “B1+, linduction magntique radiofrquence RM pertinente“. Remp
14、lacer, dans la formule, “B1RMS“ par “B1+RMS“ et “B1“ par “B1+“. Tableau 201.101 Liste des symboles Dans la 2meligne, 1recolonne remplacer “B1“ par “B1+“. Dans la 3meligne, 1recolonne remplacer “B1RMS“ par “B1+RMS“. Dans la 3meligne, 3mecolonne remplacer “B1“ par “B1+“. 201.7.9.2.101 Instructions dut
15、ilisation des APPAREILS A RM j) Exposition du PATIENT aux champs magntiques radiofrquence Dans le dernier tiret, remplacer “B1RMS“ par “B1+RMS“. Corrigendum 1:2012 to CAN/CSA-C22.2 No. 60601-2-33:12March 2012 Mars 2012 201.7.9.3.101 Technical description of MR EQUIPMENT b) Compatibility technical sp
16、ecification sheet In the 1stparagraph, 3rddashed item replace “B1RMS“ by “B1+RMS“. 201.12.4.101.2 All operating modes In the 2ndand 3rdsentences of item c) replace “B1RMS“ by“B1+RMS“ in both instances. Annex AA Particular guidance and rationale Concerning 201.3.201 B1RMS In this header replace “B1RM
17、S“ by “B1+RMS“. In the 1st and 2ndparagraphs replace“B1RMS“ by “B1+RMS“ in all 3 instances. In the 2ndparagraph replace the existing formula by the following: 21211|)(|)(|)( tBtBtB+= In the 2ndparagraph replace +1B and1B by +1B and 1B respectively. In the 3rdparagraph replace 0|)(|1=tB by 0|)(|1=tB
18、and |)(|)(|11tBtB+= by |)(|)(|11tBtB+= . In the 4thparagraph replace |1+B by |1+B and |1+= B by |1+= B . Index of defined terms used in this particular standard In the 2ndline replace “B1RMS“ by “B1+RMS“. 201.7.9.3.101 Description technique des APPAREILS RM b) Fiche de spcifications techniques de co
19、mpatibilit Dans le 1eralina, 3metiret remplacer “B1RMS“ par “B1+RMS“. 201.12.4.101.2 Tous modes de fonctionnement Dans les 2meet 3mephrases du point c) remplacer “B1RMS“ par “B1+RMS“ pour les deux cas. Annexe AA Guide particulier et justifications Concernant 201.3.201 B1RMS Dans ce titre remplacer “
20、B1RMS“ par “B1+RMS“. Dans les 1eret 2me alinas remplacer “B1RMS“ par “B1+RMS“ pour les trois cas. Dans le 2mealina remplacer la formule existante par la suivante: 21211|)(|)(|)( tBtBtB+= Dans le 2mealina remplacer +1B et1B respectivement par +1B et 1B . Dans le 3mealina remplacer 0|)(|1=tB par 0|)(|
21、1=tB et |)(|)(|11tBtB+= par |)(|)(|11tBtB+= . Dans le 4mealina remplacer |1+B par |1+B et |1+= B par |1+= B . Index des termes dfinis utiliss dans la prsente norme particulire A la 2meligne remplacer “B1RMS“ par “B1+RMS“. Corrigendum 1:2012 to CAN/CSA-C22.2 No. 60601-2-33:12CSA Standards Update Serv
22、iceCAN/CSA-C22.2 No. 60601-2-33:12February 2012Title:Medical electrical equipment Part2-33: Pa rticular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisPagination:232 pages (CSA/1CSA/13 and 219 text)To register for e-mail notification
23、about any updates to this publicationgo on-line to shop.csa.caclick on E-mail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publication is 2421679.If you require assistance, please e-mail techsupportcsa.ca or call 416-747
24、-2233.Visit CSAs policy on privacy at csagroup.org/legal to find out how we protect your personal information.Service de mise jour desnormesCSACAN/CSA-C22.2 n 60601-2-33:12Fvrier 2012Titre :Appareils lectromdicaux Part ie2-33: Exigences particulires pour la scurit de base et les performances essenti
25、elles des appareils rsonance magntique utiliss pour le diagnostic mdicalNombre de pages :232 pages (CSA/1 CSA/13 et 219 pages de texte)Vous devez vous inscrire pour recevoir les avis transmis par courriel au sujet des mises jour apportes ce document :allez au shop.csa.cacliquez sur Services par cour
26、riel 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 2421679.Si vous avez besoin daide, veuillez nous contacter par courriel au techsupportcsa.ca ou par tlphone a
27、u 416-747-2233.Consultez la politique de la CSA en matire de confidentialit au csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process
28、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 in achieving consensus, it does not independen
29、tly 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 warranties or conditions concerning this documents fitn
30、ess 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 makes no representations or warranties regarding
31、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 INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES,
32、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 THEORY OF LIABILITY, ARISING OUT OF OR RESULTING
33、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 other services for or on behalf of any person or
34、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 whatsoever arising in any way from any and all
35、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 standards or other documents it publishes. Intel
36、lectual 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 (except as otherwise noted to the contrary),
37、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 disclosure of this document may violate laws that p
38、rotect 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 property rights in this document.Patent rightsAttent
39、ion 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 determination of the validity of any such patent rights i
40、s 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 form:.load this document onto a computer for the
41、 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 only if this Legal Notice appears on each such
42、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 not agree with any of the terms and conditions
43、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 and conditions of this Legal Notice.Avis juridi
44、que concernant les normesLes normes de lAssociation canadienne de normalisation (CSA) sont labores selon un processus consensuel approuv par le Conseil canadien des normes. Ce processus rassemble des volontaires reprsentant diffrents intrts et points de vue dans le but datteindre un consensus et dla
45、borer une norme. Bien que la CSA assure ladministration de ce processus et dtermine les rgles qui favorisent lquit dans la recherche du consensus, elle ne met pas lessai, ni nvalue ou vrifie de faon indpendante le contenu de ces normes.Exclusion de responsabilitCe document est fourni sans assertion,
46、 garantie ni condition explicite ou implicite de quelque nature que ce soit, y compris, mais non de faon limitative, les garanties ou conditions implicites relatives la qualit marchande, ladaptation un usage particulier ainsi qu labsence de violation des droits de proprit intellectuelle des tiers. L
47、a CSA ne fournit aucune garantie relative lexactitude, lintgralit ou la pertinence des renseignements contenus dans ce document. En outre, la CSA ne fait aucune assertion ni ne fournit aucune garantie quant la conformit de ce document aux lois et aux rglements pertinents.LA CSA, SES VOLONTAIRES, SES
48、 MEMBRES, SES FILIALES OU SES SOCITS AFFILIES DE MME QUE LEURS EMPLOYS, LEURS DIRIGEANTS ET LEURS ADMINISTRATEURS NE PEUVENT EN AUCUN CAS TRE TENUS RESPONSABLES DE TOUTE BLESSURE, PERTE OU DPENSE OU DE TOUT PRJUDICE DIRECT, INDIRECT OU ACCESSOIRE, Y COMPRIS, MAIS NON DE FAON LIMITATIVE, TOUT PRJUDICE SPCIAL OU CONSCUTIF, TOUTE PERTE DE RECETTES OU DE CLIENTLE, TOUTE PERTE DEXPLOITATION, TOUTE PERTE OU ALTRATION DE DONNES OU TOUT AUTRE PRJUDICE CONOMIQ
