IEC 60601-2-54-2009 IEC 60601-2-54 Ed 1 Medical electrical equipment - Part 2-54 Particular requirements for the basic safety and essential performance of X-ray equipment for radio.pdf

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1、 IEC 60601-2-54Edition 1.0 2009-06INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Appareils lectromdicaux Partie 2-54: Exigences particulires po

2、ur la scurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographie et la radioscopie IEC60601-2-54:2009 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publica

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17、ATIONALEMedical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Appareils lectromdicaux Partie 2-54: Exigences particulires pour la scurit de base et les performances essentielles des appareils r

18、ayonnement X utiliss pour la radiographie et la radioscopie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XBICS 11.040.50 PRICE CODECODE PRIXISBN 2-8318-1047-5 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission E

19、lectrotechnique Internationale 2 60601-2-54 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.6 201.1 Scope, object and related standards .7 201.2 Normative references8 201.3 Terms and definitions9 201.4 General requirements .10 201.5 General requirements for testing of ME EQUIPMENT 11 201.6 Classification

20、of ME EQUIPMENT and ME SYSTEMS11 201.7 ME EQUIPMENT identification, marking and documents .11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .17 201.10 Protection against unwanted and excessive radiation HA

21、ZARDS .21 201.11 Protection against excessive temperatures and other HAZARDS .21 201.12 Accuracy of controls and instruments and protection against hazardous outputs .22 201.13 HAZARDOUS SITUATIONS and fault conditions 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).22 201.15 Construction o

22、f ME EQUIPMENT.22 201.16 ME SYSTEMS 22 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .22 202 Electromagnetic compatibility Requirements and tests .22 203 Radiation protection in diagnostic X-ray equipment.23 Annexes .58 Annex C (informative) Guide to marking and labelling requi

23、rements for ME EQUIPMENT and ME SYSTEMS59 Annex AA (informative) Particular guidance and rationale61 Bibliography64 Index of defined terms used in this particular standard65 Figure 203.101 Zone of EXTRA-FOCAL RADIATION .41 Figure 203.102 Discrepancies in covering the IMAGE RECEPTION AREA.43 Figure 2

24、03.103 Discrepancies in visual indication of the X-RAY FIELD .47 Figure 203.104 Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY below the PATIENT SUPPORT) .55 Figure 203.105 Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE ASSEMBLY below the PATIENT SU

25、PPORT) 55 Figure 203.106 Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY above the PATIENT SUPPORT) .56 Figure 203.107 Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE ASSEMBLY above the PATIENT SUPPORT)57 Table 201.101 Distributed ESSENTIAL PERFORMANC

26、E requirements 10 Table 203.101 Tests for verifying reproducibility and linearity 29 60601-2-54 IEC:2009 3 Table 203.102 Loadings for testing AUTOMATIC EXPOSURE CONTROLS.31 Table 203.103 ATTENUATION for the measurement of AIR KERMA .33 Table 203.104 ATTENUATION EQUIVALENT of items in the X-RAY BEAM.

27、49 Table 203.105 Application categories 51 Table 203.106 Requirements for PRIMARY PROTECTIVE SHIELDING 51 Table 203.107 STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY .53 Table 201.C.101 Marking on the outside of ME EQUIPMENT or its parts 59 Table 201.C.102 Subclauses requiring statements in ACCO

28、MPANYING DOCUMENTS.59 4 60601-2-54 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy FOREWORD 1) The International Electrotechnical Comm

29、ission (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

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32、ce 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 intere

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35、tween 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 u

36、sers 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 o

37、ther 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

38、. 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 pat

39、ent rights. International standard IEC 60601-2-54 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. IEC 60601-2-54 has been developed for use with the third edition of IEC 60601-1 (2005). It replaces and

40、supersedes IEC 60601-2-7 and IEC 60601-2-32, as well as IEC 60601-2-28:1993 (currently under revision), all of which were developed to amend earlier editions of IEC 60601-1 and consequently no longer apply to this particular standard. The text of this particular standard is based on the following do

41、cuments: FDIS Report on voting 62B/735/FDIS 62B/750/RVDFull information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. 60601-2-54 IEC:2009 5 This publication has been drafted in accordance with the ISO/IEC Directives, Par

42、t 2. 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

43、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 su

44、bclauses 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 standar

45、d 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 stan

46、dard, 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 permissi

47、ble 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. A list of all parts of the IEC 60601 series, published under t

48、he general title Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publ

49、ication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 6 60601-2-54 IEC:2009 INTRODUCTION This particular standard has been prepared to provide, based on IEC 60601-1:2005 (third edition) and its collaterals, a complete set of safety requirements for ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY. While the previou