BS EN 60601-2-44-2009 医用电气设备.计算机断层扫描X射线设备基本安全和基本性能的特殊要求.pdf

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Users are responsible for its correct application. © BSI 2009 ISBN 978 0 580 55588 6 ICS 11.040.50 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2009 Amendments issued since publication Amd. No. Date Text affected BRITISH STANDARDBS EN 60601-2-44:2009 EUROPEAN STANDARD EN 60601-2-44 NORME EUROPÉENNE EUROPÄISCHE NORM May 2009 CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels © 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-44:2009 E ICS 11.040.50 Supersedes EN 60601-2-44:2001 + A1:2003 English version Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009) Appareils electromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie (CEI 60601-2-44:2009) Medizinische elektrische Geräte - Teil 2-44: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgeneinrichtungen für die Computertomographie (IEC 60601-2-44:2009) This European Standard was approved by CENELEC on 2009-05-01. 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, 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. BS EN 60601-2-44:2009 EN 60601-2-44:2009 - 2 - Foreword The text of document 62B/727/FDIS, future edition 3 of IEC 60601-2-44, 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 60601-2-44 on 2009-05-01. This European Standard supersedes EN 60601-2-44:2001 + A1:2003. EN 60601-2-44:2009 constitutes a technical revision primarily related to RADIATION protection and control. 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) 2010-02-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-05-01 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 MDD (93/42/EEC). See Annex ZZ. 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. Annexes ZA and ZZ have been added by CENELEC. _ BS EN 60601-2-44:2009 - 3 - EN 60601-2-44:2009 Endorsement notice The text of the International Standard IEC 60601-2-44:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-2-7 NOTE Harmonized as EN 60601-2-7:1998 (not modified). IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified). IEC 60613 NOTE Harmonized as EN 60613:1990 (not modified). _ BS EN 60601-2-44:2009 EN 60601-2-44:2009 - 4 - 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. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace the reference to IEC 60601-1-3 by: IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 2008 Addition: IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 IEC 61223-3-5 2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment EN 61223-3-5 2004 ISO 12052 - 1) Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management - - 1) Undated reference. BS EN 60601-2-44:2009 - 5 - EN 60601-2-44:2009 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. 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. _ BS EN 60601-2-44:2009 IEC 60601-2-44 Edition 3.02009-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography Appareils électromédicaux Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE X ICS 11.040.50 PRICE CODE CODE PRIX ISBN 2-8318-1032-8 ® Registered trademark of the International Electrotechnical Commission Marque déposée de la Commission Electrotechnique Internationale ® 2 60601-2-44 IEC:2009 CONTENTS FOREWORD.3 201.1 Scope, object and related standards5 201.2 Normative references 7 201.3 Terms and definitions 7 201.4 General requirements12 201.5 General requirements for testing of ME EQUIPMENT.13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS13 201.7 ME EQUIPMENT identification, marking and documents14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT16 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS19 201.10 Protection against unwanted and excessive RADIATION HAZARDS22 201.11 Protection against excessive temperatures and other HAZARDS22 201.12 Accuracy of controls and instruments and protection against hazardous outputs22 201.13 Hazardous situations and fault conditions23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .23 201.15 Construction of ME EQUIPMENT.23 201.16 ME SYSTEMS.23 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS.24 203 General requirements for RADIATION protection in diagnostic X-ray equipment .24 Annexes .38 Annex A (informative) Choosing LOADING FACTORS for tests39 Annex B (informative) Estimating CTDIvol for scan projection RADIOGRAPHY (SPR) 40 Bibliography41 Index of defined terms used in this particular standard42 Figure 201.101 Coordinate system.9 Figure 203.101 Zone of extra-focal RADIATION29 Figure 203.102 Minimum dimensions for STRAY RADIATION measurement32 Table 203.101 Test pattern for CTDIfree air.36 BS EN 60601-2-44:2009 60601-2-44 IEC:2009 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-44 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to RADIATION protection and control. The text of this particular standard is based on the following documents: FDIS Report on voting 62B/727/FDIS 62B/734/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table.