1、 IEC 61674 Edition 2.0 2012-11 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging Appareils lectromdicaux Dosimtres chambres dionisation et/ou dtecteurs semi-conducteurs utili
2、ss en imagerie de diagnostic rayonnement X IEC61674:2012 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland 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, i
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16、 IEC 61674 Edition 2.0 2012-11 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging Appareils lectromdicaux Dosimtres chambres dionisation et/ou dtecteurs semi-conducteurs utili
17、ss en imagerie de diagnostic rayonnement X INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE W ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-83220-510-5 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechn
18、ique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 61674 IEC:2012 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope and object 7 1.1 Scope 7 1.2 Obje
19、ct . 7 2 Normative references . 7 3 Terms and definitions . 8 4 General requirements . 15 4.1 Performance requirements 15 4.2 REFERENCE VALUES and STANDARD TEST VALUES 15 4.3 General test conditions 16 4.3.1 STANDARD TEST CONDITIONS 16 4.3.2 Statistical fluctuations 17 4.3.3 STABILIZATION TIME . 17
20、4.3.4 Adjustments during test . 17 4.3.5 Batteries 17 4.4 Constructional requirements as related to performance . 18 4.4.1 Components 18 4.4.2 Display 18 4.4.3 Indication of battery condition 18 4.4.4 Indication of polarizing voltage failure 18 4.4.5 Over-ranging . 18 4.4.6 MEASURING ASSEMBLIES with
21、 multiple DETECTOR ASSEMBLIES . 19 4.4.7 Radioactive STABILITY CHECK DEVICE . 19 4.5 UNCERTAINTY of measurement . 20 5 Limits of PERFORMANCE CHARACTERISTICS 20 5.1 Linearity 20 5.2 Repeatability . 20 5.2.1 General . 20 5.2.2 Repeatability in the ATTENUATED BEAM 20 5.2.3 Repeatability in the UNATTENU
22、ATED BEAM 21 5.3 RESOLUTION of reading 21 5.4 STABILIZATION TIME . 21 5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT measurements . 22 5.6 Reset on AIR KERMA and AIR KERMA LENGTH PRODUCT ranges 22 5.7 Effects of LEAKAGE CURRENT . 22 5.7.1 AIR KERMA RATE measurements 22 5.7.
23、2 AIR KERMA and AIR KERMA LENGTH PRODUCT measurements . 22 5.8 Stability . 23 5.8.1 Long term stability . 23 5.8.2 Accumulated dose stability 23 5.9 Measurements with a radioactive STABILITY CHECK DEVICE 23 6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES 24 6.1 General . 24 6.2 Energy depe
24、ndence of RESPONSE 24 61674 IEC:2012 3 6.3 AIR KERMA RATE dependence of AIR KERMA and AIR KERMA LENGTH PRODUCT measurements . 25 6.3.1 MEASURING ASSEMBLY . 25 6.3.2 IONIZATION CHAMBER Recombination losses . 26 6.4 Dependence of DETECTOR RESPONSE on angle of incidence of radiation . 26 6.4.1 Non-CT d
25、etectors 26 6.4.2 CT DETECTORS . 26 6.5 Operating voltage 27 6.5.1 Mains-operated DOSIMETERS 27 6.5.2 Battery-operated DOSIMETERS 27 6.5.3 Mains rechargeable, battery-operated DOSIMETERS 27 6.6 Air pressure . 28 6.7 Air pressure EQUILIBRATION TIME of the RADIATION DETECTOR . 28 6.8 Temperature and h
26、umidity . 28 6.9 Electromagnetic compatibility 29 6.9.1 ELECTROSTATIC DISCHARGE . 29 6.9.2 Radiated electromagnetic fields . 29 6.9.3 CONDUCTED DISTURBANCES induced by bursts and radio frequencies 30 6.9.4 Voltage dips, short interruptions and voltage VARIATIONS . 30 6.10 Field size . 30 6.11 EFFECT
27、IVE LENGTH and spatial uniformity of RESPONSE of CT DOSIMETERS . 30 7 Marking 31 7.1 DETECTOR ASSEMBLY 31 7.2 MEASURING ASSEMBLY 31 7.3 Radioactive STABILITY CHECK DEVICE . 31 8 ACCOMPANYING DOCUMENTS . 31 Annex A (informative) COMBINED STANDARD UNCERTAINTY for dosimeter performance 33 Index of defi
28、ned terms 34 Table 1 REFERENCE and STANDARD TEST CONDITIONS . 16 Table 2 Number of readings required to detect true differences (95 % confidence level) between two sets of instrument readings . 17 Table 3 Maximum values for the COEFFICIENT OF VARIATION, vmax, for measurements in the attenuated beam
29、 21 Table 4 Maximum values for the COEFFICIENT OF VARIATION, vmax, for measurements in the unattenuated beam . 21 Table 5 LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 24 Table 6 Climatic conditions 28 Table A.1 Estimation of COMBINED STANDARD UNCERTAINTY for dosimeter performance 3
30、3 4 61674 IEC:2012 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardi
31、zation 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 Interna
32、tional 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 i
33、n 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
34、 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
35、 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 misin
36、terpretation 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 nation
37、al or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services ca
38、rried out by independent certification bodies. 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 C
39、ommittees 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 draw
40、n 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
41、be held responsible for identifying any or all such patent rights. International Standard IEC 61674 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This second editio
42、n cancels and replaces the first edition of IEC 61674. This edition constitutes a technical revision. The text of this standard is based on the following documents: FDIS Report on voting 62C/551/FDIS 62C/555/RVD Full information on the voting for the approval of this standard can be found in the rep
43、ort on voting indicated in the above table. 61674 IEC:2012 5 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material app
44、earing 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 IEC 60601-1, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. The verbal forms used in this standard conform to usage described
45、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 mandat
46、ory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.
47、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. 6 61674 IEC:2012 INTRODUCTION Diagnostic radiology is the largest contributor to man-made IONIZING RADIATION to which the public is exposed. T
48、he reduction in the exposure received by PATIENTS undergoing medical radiological examinations or procedures has therefore become a central issue in recent years. The PATIENT dose will be minimized when the X-ray producing equipment is correctly adjusted for image quality and radiation output. These
49、 adjustments require that the routine measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT and/or AIR KERMA RATE be made accurately. The equipment covered by this standard plays an essential part in achieving the required accuracy. The DOSIMETERS used for adjustment and control measurements must be of satisfactory quality and must therefore fulfil the special requirements laid down in this standard. 6167
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