I E C 60 60 -2 -3 ® Edition 3.2 201 5-06 C ON S OLI D ATE D VE RS I ON VE RS I ON C ON S OLI D É E colour i n sid e M ed i cal el ectri cal e q u i pm e n t – P art -33 : P arti cu l ar re q u i re m e n ts for th e bas i c s afe ty an d e s sen ti al perform an ce of m ag n e ti c res on an ce eq u i pm en t for m ed i cal d i ag n os i s Ap parei l s él ectrom éd i cau x – P arti e -3 3: Exi g e n ces parti cu l i è res pou r l a s écu ri té d e base et l es perform an ces es se n ti el l es d es apparei l s rés on an ce m ag n éti q u e u ti l i s é s pou r l e d i ag n os ti c 60601 -2-33:201 0-03+AMD1 :201 3-04+AMD2 :201 5-06 CSV(en-fr) m é d i cal T H I S P U B L I C AT I O N I S C O P YRI G H T P RO T E C T E D C o p yri g h t © I E C , G e n e v a , S wi tz e rl a n d All rights reserved Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's member National Committee in the country of the requester If you have any questions about I EC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local I EC member National Committee for further information Droits de reproduction réservés Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur Si vous avez des questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence IEC Central Office 3, rue de Varembé CH-1 21 Geneva 20 Switzerland Tel.: +41 22 91 02 1 Fax: +41 22 91 03 00 info@iec.ch www.iec.ch Ab ou t th e I E C The I nternational Electrotechnical Commission (I EC) is the leading global organization that prepares and publishes I nternational Standards for all electrical, electronic and related technologies Ab o u t I E C p u b l i ca ti o n s The technical content of IEC publications is kept under constant review by the IEC Please make sure that you have the latest edition, a corrigenda or an amendment might have been published I E C Catal og u e - 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webstore i ec ch /csc Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csc@iec.ch I E C 60 60 -2 -3 ® Edition 3.2 201 5-06 C ON S OLI D ATE D VE RS I ON VE RS I ON C ON S OLI D É E colour i n sid e M ed i cal el ectri cal eq u i pm en t – P art -33 : P arti cu l ar req u i rem en ts for th e bas i c s afety an d e s sen ti al pe rform an ce of m ag n e ti c res on an ce eq u i pm en t for m ed i cal d i ag n os i s Ap parei l s é l ectrom é d i cau x – P arti e -3 3: Exi g e n ces parti cu l i è res pou r l a s écu ri té d e base e t l es pe rform an ces es sen ti el l e s d es apparei l s rés on an ce m ag n é ti q u e u ti l i s és pou r l e d i ag n os ti c m é d i cal INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 1 040.55 ISBN 978-2-8322-2743-5 Warn i n g ! M ake s u re th at you obtai n ed th i s p u b l i ca ti on from an au th ori zed d i stri b u tor Atten ti on ! Veu i l l ez vou s ass u rer q u e vou s avez obten u cette pu bl i cati on vi a u n d i stri b u teu r ag ré é ® Registered trademark of the International Electrotechnical Commission I E C 60 60 -2 -3 ® Edition 3.2 201 5-06 RE D LI N E VE RS I ON VE RS I ON RE D LI N E colour i n sid e M ed i cal el ectri cal e q u i pm e n t – P art -33 : P arti cu l ar re q u i re m e n ts for th e bas i c s afe ty an d e s sen ti al perform an ce of m ag n e ti c res on an ce eq u i pm en t for m ed i cal d i ag n os i s Ap parei l s él ectrom éd i cau x – P arti e -3 3: Exi g e n ces parti cu l i è res pou r l a s écu ri té d e base et l es perform an ces es se n ti el l es d es apparei l s rés on an ce m ag n éti q u e u ti l i s é s pou r l e d i ag n os ti c 60601 -2-33:201 0-03+AMD1 :201 3-04+AMD2 :201 5-06 CSV(en-fr) m é d i cal –2– I EC 60601 -2-33:201 +AMD1 : 201 3+AMD2: 201 CSV I EC 201 CONTENTS FOREWORD * I NTRODU CTI ON I NTRODUCTI ON TO AM EN DMENT I NTRODUCTI ON TO AM EN DMENT 201 Scope, obj ect and related standards 201 Norm ative references 201 Terms and definitions 1 201 General requirem ents 201 General requirements for testing of ME EQUI PMENT 201 Classification of ME EQUI PMENT and ME SYSTEMS 201 M E EQUI PMENT identification, marking and documents 201 Protection against electrical HAZARDS from ME EQU I PMENT 32 201 Protection against m echanical HAZARD s of ME EQUI PMENT and ME SYSTEMS 32 201 Protection against unwanted and excessive radiation HAZARDS 33 201 1 Protection against excessive temperatures and other HAZARDS 33 201 Accuracy of controls and instruments and protection against hazardous outputs 33 201 H AZARDOUS SI TUATI ONS and fault conditions 54 201 P ROGRAM MABLE ELECTRI CAL MEDI CAL SYSTEM ( PEMS ) 54 201 Construction of ME EQUI PMENT 54 201 M E SYSTEMS 54 * 201 Electromagnetic compatibility of ME EQUI PMENT and ME SYSTEMS 55 * 202 Electromagnetic com patibility – Requirem ents and tests 55 Annexes 57 Annex D (inform ative) Symbols on m arking 58 Annex AA (inform ative) Particular guidance and rationale 62 Bibliograph y 1 I ndex of defined terms used in this particular standard 31 Figure 201 01 – Gradient waveform and EFFECTI VE STI MULUS DU RATI ON Figure 201 02 – Limits for cardiac and peripheral nerve stim u lation 38 Figure 201 03 – Reduction of WHOLE BODY SAR lim its at high tem peratures 42 Figure 201 04 – Volum e for determ ining the spatial maxim um of gradient output 48 Figure 201 05 – Volum e for determ ining the B stray field 51 Figure 201 D 01 – Signs indicating a transm it onl y RF coil, transm it / receive RF coil and a receive onl y coil Figure AA – Static magnetic fields: flow potentials and retardation 88 Figure AA – Experimental data on PN S threshold of human volunteers in WHOLE BODY MR EQUI PMENT 04 Figure AA – Double logarithm ic plot of experimental threshold values for peripheral nerve stim ulation 05 Figure AA – Response value R( t) generated by convolution of a rectangular stimulus d B /d t and a nerve impulse response function n ( t- θ ) 09 I EC 60601 -2-33: 201 –3– +AMD1 : 201 3+AMD2: 201 CSV I EC 201 Figure AA – Gradient waveform G , stim ulus waveform d B/d t and response value R , for a trapezoid EPI waveform starting at t = 1 Figure AA – Threshold values d B/d t for two gradient waveform s, plotted against EFFECTI VE STI MULUS DU RATI ON 1 Figure AA – Threshold value of d B/d t for a sinusoid gradient waveform , as function of the num ber of half periods in the waveform 1 Figure AA – SAR limits for the exposed mass of a PATI ENT 1 Table 201 01 – List of sym bols and abbreviations Table 201 02 – Rheobase values per type of gradient system 37 Table 201 03 – Weight factors for summation of the m axim um output O i per GRADI ENT U NI T 39 Table 201 04 – Tem perature limits 39 Table 201 05 – SAR lim its for volume transmit coils 40 Table 201 06 – SAR lim its for local transmit coils 41 Table 201 07 – FPO lim its applicable for cylindrical M R SYSTEMS 52 Table 201 D 01 – Example of warning signs and prohibitive signs 58 Table 201 D 02 – RF coil sym bols 60 Table 201 D 03 – MR conditional symbols 61 Table AA – Static field occupational standards Table AA – Overview ph ysiological effects in hum ans, animals and m odel systems, for magnetic-field exposures at field strengths relevant for MRI The im plications of the reported effects are assessed in the last column 77 M R S AF E T Y S I G N S –4– I EC 60601 -2-33:201 +AMD1 : 201 3+AMD2: 201 CSV I EC 201 INTERNATI ONAL ELECTROTECHNI CAL COMMISSI ON M E D I C AL E L E C T RI C AL E Q U I P M E N T – P a rt -3 : P a rti c u l a r re q u i re m e n ts fo r th e b a s i c s a fe t y a n d e s s e n ti a l p e rfo rm a n c e o f m a g n e ti c re s o n a n c e e q u i p m e n t fo r m e d i c a l d i a g n o s i s FOREWORD ) The I nternati on al Electrotechni cal Comm ission (I EC) is a worl d wid e organization for stan dardization com prisin g all n ation al el ectrotechnical comm ittees (I EC National Comm ittees) The object of I EC is to prom ote internati onal co-operation on all q uestions concerni ng stand ardi zati on in the el ectrical an d electronic fi elds To this en d and in additi on to other acti vities, I EC pu blish es I nternational Stan dards, Techn ical Specificati ons, Technical Reports, Publicl y Avail abl e Specificati ons (PAS) an d Guides (hereafter referred to as “I EC Publication(s)”) Th ei r preparation is entrusted to tech nical comm ittees; any I EC N ational Comm ittee interested in the subj ect dealt with m ay partici pate in this preparatory work I nternational, governm ental an d n on governm ental organ izations l iaising with th e I EC also participate i n this preparation I EC collaborates closel y with the I ntern ational Organi zation for Stand ardization (I SO) in accordance with ditions determ ined by agreem ent between th e two organi zati ons 2) The form al decisions or ag reem ents of I EC on tech nical m atters express, as n early as possible, an i nternati onal consensus of opi nion on the rel evant subjects since each technical com m ittee has representati on from all interested I EC N ational Com m ittees 3) I EC Publications have the form of recom m endations for intern ational use an d are accepted by I EC National Com m ittees in that sense While all reasonable efforts are m ade to ensure that the tech nical content of I EC Publications is accu rate, I EC cann ot be h eld responsi ble for th e way in which th ey are used or for an y m isinterpretation by an y en d u ser 4) I n order to prom ote intern ational u niform ity, I EC National Com m ittees und ertake to apply I EC Publications transparentl y to the m axim um extent possible i n their national an d regi on al publicati ons Any d ivergence between an y I EC Publication and the correspondi ng national or regi on al publicati on sh all be clearl y in dicated in the latter 5) I EC itself d oes n ot provi de an y attestation of conform ity I n depend ent certificati on bodies provi de conform ity assessm ent services and, in som e areas, access to I EC m arks of conform ity I EC is not responsi ble for any services carri ed out by ind ependent certification bodi es 6) All users shou ld ensure that th ey have the l atest editi on of thi s publicati on 7) No liability shall attach to I EC or its directors, em ployees, servants or ag ents inclu din g in divi dual experts an d m em bers of its technical com m ittees and I EC Nati on al Com m ittees for any person al i njury, property d am age or other dam age of any nature whatsoever, wheth er di rect or indirect, or for costs (includ i ng leg al fees) and expenses arisi ng out of the publ ication, use of, or relian ce upon, this I EC Publicati on or any other I EC Publications 8) Attention is drawn to th e N orm ative references cited in th is publ ication Use of the referenced publ ications is indispensable for the correct applicati on of this publication 9) Attention is drawn to the possibility that som e of the elem ents of this I EC Publication m ay be the su bject of patent rig hts I EC shall not be held responsibl e for identifyi ng any or all such patent ri ghts D I S C L AI M E R Th i s C o n s o l i d a te d u s er ven i en ce v e rs i o n On l y is th e n ot a re t o b e c o n s i d e re d t h e o ffi c i a l Th i s Con so l i d ated th e t h i rd ed i ti on (2 -0 4) v e rs i o n ( 0-03) [d o cu m e n ts B / 7 /F D I S base e d i ti on an d In th i s m o d i fi e d Red l i n e d el eti on s by ava i l ab l e i n IEC v e rs i o n s S t a n d a rd of th e an d s t a n d a rd [d ocu m en ts an d h as been and i ts p re p a re d fo r am e n d m e n t( s ) d o cu m e n ts o f I E C 6 - - 3 b e a rs t h e e d i t i o n B / 7 /F D I S an d an d B / /R VC ] B /9 / R VD ] Th e n u m ber B /7 /RVD ] , an d te ch n i ca l i ts I t s i s ts of i ts am en d m en t co n ten t is am en d m en t ( 5-0 6) i d en ti cal to th e i t s a m e n d m e n ts v e rs i o n , a v e rt i c a l am en d m en ts bei n g o ffi c i a l B / 8 /C D V [d ocu m en ts is an c u rre n t s t ru c k t h ro u g h th i s p u b l i c a ti o n line an d A in th e m a rg i n Ad d i t i o n s s e p a t e an d Fi n al s h o ws w h e re d e l e ti o n s v e rs i o n a re wi th al l th e te c h n i c al d i s p l a ye d ch an g e s in co n ten t re d , wi th accepted is I EC 60601 -2-33: 201 –5– +AMD1 : 201 3+AMD2: 201 CSV I EC 201 International standard I EC 60601 -2-33 has been prepared by I EC subcomm ittee 62B: Diagnostic imaging equipment, of I EC technical committee 62: Electrical equipment in m edical practice This edition of I EC 60601 -2-33 is based on the second amendm ent to Edition I t has also been adapted to the third edition of I EC 60601 -1 (2005), with technical modifications being introduced where appropriate This publication has been drafted in accordance with the I SO/I EC Directives, Part In this standard, the following print types are used: – Requirem ents and definitions: roman type – Test specifica tions: ita lic typ e – I nform ative m ateri al appearing outside of tables, such as n otes, exam ples and references: in sm aller type Norm ative text of tabl es is also in a sm aller type – T ERMS DEFI NED I N C LAUSE OF THE GENERAL STAN DARD , I N THI S PARTI CULAR STANDARD OR AS NOTED : SMALL CAPI TALS I n referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e g Clause includes subclauses , 2, etc ); – “subclause” m eans a num bered subdivision of a clause (e g , 7.2 and are all subclauses of Clause 7) References to clauses within this standard are preceded by the term “Clause” followed by the clause num ber References to subclauses within this particular standard are by num ber onl y I n this standard, the conjunctive “or” is used as an “inclusive or” so a statem ent is true if an y com bination of the conditions is true The verbal forms used in this standard conform to usage described in Annex H of the I SO/I EC Directives, Part For the purposes of this standard, the auxiliary verb: – “shall” m eans that compliance with a requirement or a test is m andatory for compliance with this standard; – “should” means that com pliance with a requirem ent or a test is recomm ended but is not m andatory for com pliance with this standard; – “m ay” is used to describe a perm issible way to achieve com pliance with a requirement or test An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA A list of all parts of the I EC 60601 series, published under the general title: equipm e nt, can be found on the I EC website Me dica l e lectrica l –6– I EC 60601 -2-33:201 +AMD1 : 201 3+AMD2: 201 CSV I EC 201 The committee has decided that the contents of the base publication and its amendments will remain unchanged until the stability date indicated on the I EC web site under "http://webstore iec.ch" in the data related to the specific publication At this date, the publication will be • reconfirmed, • withdrawn, • replaced by a revised edition, or • amended The tents of th e corri gend um of March 201 h ave been i ncl ud ed i n th is copy I M P O RT AN T th a t it – Th e co n ta i n s u n d e rs t a n d i n g c o l o u r p ri n t e r of ' co l ou r c o l o u rs i ts i n si de' wh i ch c o n te n ts l ogo a re U s e rs on th e cover c o n s i d e re d sh ou l d p ag e to t h e re fo re of th i s be p ri n t p u b l i cati on u s e fu l th i s fo r i n d i c ate s th e d ocu m e n t c o rre c t u si n g a – 252 – IEC 6060 -2-3 3: + AM D : + AM D : [2 ] S C H E N C K, Tesl a 649, [2 ] [2 ] [2 ] [2 ] [2 ] [3 ] [3 ] [3 ] [3 ] [3 ] [3 ] [3 ] [3 ] [3 ] JF H e a l th m a g n e ti c fi e l d s and p h ys i o l o g i c a l d u ri n g L YL E , BL , et an d al M o d u l a ti o n l eu kem i c of C a l ci u m T - l ym p h o c yt e s [3 ] H AB E RD I T Z L , [4 ] M AN S F I E L D W P E n z ym e an d San M C L AU C H L A N , 981 , 67, 50 a cti vi t y i n M O RR I S , PG K A W AU G H , J N e w Y o rk : P E RS S O N , Th e B i o m a g n eti c B RR NMR e ffe c t s e ffe c t s , Ac a d e m i c an d In S AU N D E R S , RD , an d 984, In NMR FG B i o l o g i ca l TS , im aging I m ag i n g in S H E L L O C K, fi e l d [4 ] [4 ] an d an d H on F e ffe c t s J S, As s o c FG , P h ys fo u r- 992, D , ch a n g e T S H ON G , fi e l d in E m b r yo n i c CT to CZ d oes Imaging , Med , Annual ou abai n in c yc l o t ro n Meeting Nature , 967, In 21 3, of the p 72 W AU G H , P re s s , ch e m i ca l 73 J S., ed 982 Sci Prog re a c t i o n s DJ , of D J and , m i ce , 990, T E N F O RD E , s ta ti o n a ry m a g n e ti c AN D n ot 990, S H E L L O C K, a ffe c t 8, and s a fe t y a s p e c ts of of P h ys i c s NMR D e p t , cl i n i ca l L a s a re t t e t British i m ag i n g a s p e c ts B i o l o g i ca l In of m a g n eti c e ffe c t s T H O M AS , an d S R , p h ys i c a l an d D I XO N , M ed i ca l G O RD O N CJ E ffe c t Magn Reson Med , and of i m ag i n g s a fe t y RL , a s p e cts eds M o n o g p h of NMR in N o 4, N ew p 93-54 an d R re s o n a n c e p 43 -261 xe n o p u s , 984, l a e vi s of 986, D R AN S F I E L D , D K 71 , u n d er a ,5 3, T s ta t i c m a g n eti c p 644-647 M a g n e ti c fi e l d i n d u ce d p 01 s ta t i c m a g n eti c fi e l d s up to p 584 -58 43 TS B i o e l e c t ri c fi e l d s FG p ro p e rt i e s of fro g Radiat Environ Biophys S h o rt - t e rm s o m a t o - s e n s o r y- e v o k e d p 65-6 h a z a rd s Ra d i a ti o n Naturwissenschaften 67, , Seminars on Biomedical Applications a s p e c ts s a fe t y 5(4), TF m an d e ve l o p m e n t Advances in Magnetic Resonance h e a l th ed S we d e n : and 986, O L D E N B O U RG , J Appl Phys G AF F E Y , an d 54 989, S C H AE F E R , t e m p e t u r e UENO, A u n d e r ca l ci u m Ac a d e m i c on ed P o te n ti a l B RR, s p e c t ro s c o p y b o d y t e m p e t u re e xp o s u re [5 ] , 982 S a fe t y p 48 B U D I N G E R, i n - vi vo S P E RB E R, 6, 34 [5 ] Am e r fi e l d s B i om ed i ci n e fi e l d s Medicine: Instrumentation and Clinical Applications Y o rk : [4 ] wh o l e - b o d y p 51 N e w Yo rk : W AU G H , Lun d , S M I TH , 40(2), Magnetic Resonance Quarterly T E N F O RD E , ca n a va l i n Twelfth 990, m a g n eti c B E RT I L , , [4 ] NMR of T X, by m a g n e ti c m a g n e t i c fi e l d s S u ppl S T AH L B E R G , exa m i n a ti o n s Medical Bulletin S H E L L O C K, , high P re s s , of Nuclear Magnetic Resonance [4 ] to 529 Suppl cl i n i ca l [4 ] An to n i o , Advances in Magnetic Resonance to of the co n d i ti o n s , U p ta ke e xp os e d Abstracts Bioelectromagnetics Society [4 ] e x p o s u re Annals of the New York Academy of Sciences M RI 201 Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé Supprimé re s o n a n c e [4 ] of h u m an I EC p 85-301 n o rm a l [4 ] e ffe c t s CSV e x p o s u re to p o te n ti a l s in a , ,5 m an s ci a ti c 983, Tesl a n e rv e s 22, d u ri n g p 61 -7 s ta ti c m a g n e ti c Magnetic Resonance IEC 060 -2-33 : + AM D : + AM D : [5 ] H ON G , CZ , AT K I N S , [5 ] C O O K, [5 ] [5 ] [5 ] PW o f m a l i g n a n t, B AR N O T H Y , M F EI SELEI N , J E , 8, to p 1 B U D I N G E R, K AN A L , th e DE H u m an TF , E , u n d er B RI S T O L , T h i rd KAY, A M , 96 7, C l i n i co [6 ] C U N H A, E ffe c t s G p 21 of ta i l n e rve 21 m a g n e ti c E ffe c t Nature m i ce In Plen um MW fi e l d s S., H A L B AC H , m a g n eti c 966, 21 , on , cel l u l a r Vo l N ew fi e l d s th e of Biological ed p 09 e ffe c t s on p 43 MF., 964, B i ol og i ca l p 383 Field : of , B a rn o t h y, P re s s , 32, M C RO B B I E D., i m p l i ca ti o n s fo r m a g n eti c YE N , C K m e e ti n g , and fi e l d s 8, 26 m a g n 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