1、 IEC 61331-2 Edition 2.0 2014-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Protective devices against diagnostic medical X-radiation Part 2: Translucent protective plates Dispositifs de protection radiologique contre les rayonnements X pour diagnostic mdical Partie 2: Plaques translucides de prote
2、ction radiologique IEC 61331-2:2014-05(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 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, including ph
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19、 lIEC. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 61331-2 Edition 2.0 2014-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Protective devices against diagnostic medical X-radiatio
20、n Part 2: Translucent protective plates Dispositifs de protection radiologique contre les rayonnements X pour diagnostic mdical Partie 2: Plaques translucides de protection radiologique INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE L ICS 11.040.50 PRICE CODE CO
21、DE PRIX ISBN 978-2-8322-1563-0 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obte
22、nu cette publication via un distributeur agr. 2 IEC 61331-2:2014 IEC 2014 CONTENTS FOREWORD . 3 1 Scope 5 2 Normative references 5 3 Terms and definitions 6 4 Geometrical accuracy of translucent protective plates . 6 4.1 Flatness and minimum thickness 6 4.2 Edges 7 5 Optical quality of material 7 5.
23、1 Inhomogeneities 7 5.2 Transmittance 7 6 ATTENUATION properties . 7 6.1 Determination of LEAD EQUIVALENT 7 6.2 Homogeneity 7 6.3 Minimum thickness and LEAD EQUIVALENT . 7 6.4 Information 8 7 Marking . 8 8 ACCOMPANYING DOCUMENTS 9 9 Statement of compliance . 9 Bibliography 10 Index of defined terms
24、used in this International Standard 11 Table 1 Ratio of LEAD EQUIVALENT and minimum thickness for PROTECTIVE GLASS PLATES 8 Table 2 Information and data for marking PROTECTIVE GLASS PLATES . 8 IEC 61331-2:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ PROTECTIVE DEVICES AGAINST DIAGNOST
25、IC MEDICAL X-RADIATION Part 2: Translucent protective plates 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
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32、dependent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) N
33、o 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
34、 (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 applicat
35、ion 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 61331-2 has been prepared by subcommitt
36、ee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 61331-2, published in 1994. It constitutes a technical revision. This second edition has been adapted to apply to the prese
37、nt technology. The essential changes and extensions are: extension of scope to cover all kinds of TRANSLUCENT PROTECTIVE PLATES and all kinds of RADIATION QUALITIES and GAMMA RADIATION; removal of definition and requirements for TRANSLUCENT PROTECTIVE PLATES for visual imaging; changes of requiremen
38、ts concerning geometrical accuracy and optical quality; changes of requirements concerning determination of LEAD EQUIVALENT and minimal thickness; 4 IEC 61331-2:2014 IEC 2014 changes of requirements concerning information and marking The text of this standard is based on the following documents: FDI
39、S Report on voting 62B/937/FDIS 62B/943/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print t
40、ypes are used: requirements and definitions: roman 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 THIS STANDARD OR AS NOTED: SMALL CAPS. The verbal forms
41、 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 requ
42、irement 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. A list of all parts of the IEC 61331 series, published under the general title Protective devices against diagnostic
43、medical X-radiation, can be found on the IEC website. 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.ch“ in the data related to the specific publication. At this date, the publicat
44、ion will be reconfirmed, withdrawn, replaced by a revised edition, or amended. IEC 61331-2:2014 IEC 2014 5 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION Part 2: Translucent protective plates 1 Scope This part of IEC 61331 applies to TRANSLUCENT PROTECTIVE PLATES used for RADIATION PROTEC
45、TION in X-ray diagnosis and in X-ray therapy. It also applies to TRANSLUCENT PROTECTIVE PLATES used for protection against GAMMA RADIATION in nuclear medicine and BRACHYTHERAPY with automatically-controlled AFTERLOADING equipment. It does not cover other translucent RADIATION PROTECTION materials, e
46、.g. leaded glasses or goggles for protection of the OPERATORS eyes (eye spectacles), leaded face shields, which cover the entire face of the OPERATOR, PATIENT eye protection, and thyroid/neck PROTECTIVE DEVICES. This Part 2 deals with the requirements on geometrical accuracy; optical quality of the
47、material; spectral TRANSMITTANCE; radiation ATTENUATION properties; marking; statement of compliance with this standard. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, o
48、nly the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005/AMD1:2012 IEC 60601-1-3:200
49、8, Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X- ray equipment IEC 60601-1-3:2008/AMD1:2013 IEC 60601-2-8:2010, Medical electrical equipment Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV IEC/TR 60788:2004
