CAN CSA-C22 2 NO 60601-2-33-2012 Medical electrical equipment - Part 2-33 Particular requirements for the basic safety and essential performance of magnetic resonance equipment for.pdf

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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

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