EN 60601-2-33:2010

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-33:2010)Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical (CEI 60601-2-33:2010)Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-33:2010SIST EN 60601-2-33:2010en01-december-2010SIST EN 60601-2-33:2010SLOVENSKI
STANDARDSIST EN 60601-2-33:2003/A2:2008SIST EN 60601-2-33:2003/A1:2007SIST EN 60601-2-33:20031DGRPHãþD

EUROPEAN STANDARD EN 60601-2-33 NORME EUROPÉENNE
EUROPÄISCHE NORM October 2010
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2010 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-33:2010 E
ICS 11.040.55 Supersedes EN 60601-2-33:2002 + A1:2005 + A2:2008
English version
Medical electrical equipment -
Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010)
Appareils électromédicaux -
Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical (CEI 60601-2-33:2010)
Medizinische elektrische Geräte -
Teil 2-33: Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik (IEC 60601-2-33:2010)
This European Standard was approved by CENELEC on 2010-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
Foreword The text of document 62B/777/FDIS, future edition 3 of IEC 60601-2-33, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-33 on 2010-10-01. This European Standard supersedes EN 60601-2-33:2002 + A1:2005 + A2:2008. This EN 60601-2-33:2010 is based on the second amendment to EN 60601-2-33:2002. It has also been adapted to EN 60601-1:2006, with technical modifications being introduced where appropriate. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2011-07-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2013-10-01 In this standard, the following print types are used: –
Requirements and definitions: roman type. –
Test specifications: italic type. –
Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. –
TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In 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 7 includes subclauses 7.1, 7.2, etc.); –
“subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: –
“shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; –
“should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; –
“may” is used to describe a permissible way to achieve compliance 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. SIST EN 60601-2-33:2010

- 3 - EN 60601-2-33:2010 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60601-2-33:2010 was approved by CENELEC as a European Standard without any modification. __________
Annex ZA
(normative)
Normative references to international publications with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE
When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.
Clause 2 of the general standard applies except as follows: Publication Year Title EN/HD Year
Replacement:
IEC 60601-1 2005 Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance EN 60601-1 + corr. March
2006 2010
Addition:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March
2007 2010
NEMA MS 4 2006 Acoustic noise measurement procedure for diagnostic magnetic resonance imaging (MRI) devices - -
NEMA MS 8 2008 Characterization of the specific absorption rate (SAR) for magnetic resonance imaging systems - -
- 5 - EN 60601-2-33:2010 Annex ZZ (informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC with the exception of ERs 3, 4, 7.1 and 12.1. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.
IEC 60601-2-33Edition 3.0 2010-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment –
Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Appareils électromédicaux –
Partie 2-33: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XEICS 11.040.55 PRICE CODECODE PRIXISBN 2-8318-1081-8
– 2 – 60601-2-33 © IEC:2010 CONTENTS FOREWORD.54 INTRODUCTION.6H6H7 201.1 Scope, object and related standards.7H7H8 201.2 Normative references.8H8H9 201.3 Terms and definitions.9H9H10 201.4 General requirements.10H10H15 201.5 General requirements for testing of ME EQUIPMENT.11H11H15 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.12H12H15 201.7 ME EQUIPMENT identification, marking and documents.13H13H16 201.8 Protection against electrical HAZARDS from ME EQUIPMENT.14H14H27 201.9 Protection against mechanical HAZARDs of ME EQUIPMENT and ME SYSTEMS.15H15H28 201.10 Protection against unwanted and excessive radiation HAZARDS.16H16H28 201.11 Protection against excessive temperatures and other HAZARDS.17H17H28 201.12 Accuracy of controls and instruments and protection against hazardous outputs.18H18H29 201.13 HAZARDOUS SITUATIONS and fault conditions.19H19H47 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS).20H20H47 201.15 Construction of ME EQUIPMENT.21H21H47 201.16 ME SYSTEMS.22H22H47 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.23H23H47 202 Electromagnetic compatibility – Requirements and tests.24H24H48 Annexes.25H25H48 Annex D (informative)
Symbols on marking.26H26H49 Annex AA (informative)
Particular guidance and rationale.27H27H51 Bibliography.28H28H96 Index of defined terms used in this particular standard.29H29H104
Figure 201.101 – Gradient waveform and EFFECTIVE STIMULUS DURATION.30H30H11 Figure 201.102 – Limits for cardiac and peripheral nerve stimulation.31H31H33 Figure 201.103 – Reduction of WHOLE BODY SAR limits at high temperatures.32H32H37 Figure 201.104 – Volume for determining the spatial maximum of gradient output.33H33H43 Figure 201.105 – Volume for determining the B1 stray field.34H34H46 Figure 201.D.101 – Signs indicating a transmit only RF coil, transmit / receive RF coil and a receive only RF coil.35H35H50 Figure AA.1 – Static magnetic fields: flow potentials and retardation.36H36H68 Figure AA.2 – Experimental data on PNS threshold of human volunteers
in WHOLE BODY MR EQUIPMENT.37H37H83 Figure AA.3 – Double logarithmic plot of experimental threshold values
for peripheral nerve stimulation.38H38H84 Figure AA.4 – Response value R(t) generated by convolution of a rectangular stimulus dB/dt and a nerve impulse response function n(t-θ).39H39H88 Figure AA.5 – Gradient waveform G, stimulus waveform dB/dt and response value R,
for a trapezoid EPI waveform starting at t = 0.40H40H89 SIST EN 60601-2-33:2010

60601-2-33 © IEC:2010 – 3 – Figure AA.6 – Threshold values dB/dt for two gradient waveforms,
plotted against EFFECTIVE STIMULUS DURATION.41H41H89 Figure AA.7 – Threshold value of dB/dt for a sinusoid gradient waveform,
as function of the number of half periods in the waveform.42H42H90 Figure AA.8 – SAR limits for the exposed mass of a PATIENT.43H43H93
Table 201.101 – List of symbols.44H44H15 Table 201.102 – Rheobase values per type of gradient system.45H45H32 Table 201.103 – Weight factor
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