IEC 61331-3-2014 Protective devices against diagnostic medical X-radiation - Part 3 Protective clothing eyewear and protective patient shields《防医疗诊断用X射线的防护装置 第3部分 防护服 护目镜和患者防护罩》.pdf

1、 IEC 61331-3 Edition 2.0 2014-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Protective devices against diagnostic medical X-radiation Part 3: Protective clothing, eyewear and protective patient shields Dispositifs de protection radiologique contre les rayonnements X pour diagnostic mdical Partie 3:

2、 Vtements et lunettes de protection radiologique, crans de protection pour le patient IEC 61331-3:2014-05(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

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20、RNATIONALE Protective devices against diagnostic medical X-radiation Part 3: Protective clothing, eyewear and protective patient shields Dispositifs de protection radiologique contre les rayonnements X pour diagnostic mdical Partie 3: Vtements et lunettes de protection radiologique, crans de protect

21、ion pour le patient INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE U ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-8322-1564-7 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale War

22、ning! 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 IEC 61331-3:2014 IEC 2014 CONTENTS FOREWORD . 5 1 Scope 7 2 Normative references . 7 3 Terms and definitions. 8 4 Gene

23、ral . 9 4.1 ACCOMPANYING DOCUMENTS . 9 4.2 Language of the ACCOMPANYING DOCUMENTS . 9 4.3 General requirement on marking 9 4.4 Design . 9 4.4.1 PROTECTIVE DEVICES for the protection of OPERATORS 9 4.4.2 PROTECTIVE DEVICES for the protection of the PATIENT 10 4.5 Materials 10 4.5.1 Materials effectin

24、g ATTENUATION 10 4.5.2 Cleaning . 10 4.5.3 Touchable surfaces . 10 5 PROTECTIVE APRONS and THYROID COLLARS . 10 5.1 General 10 5.2 Design . 10 5.3 Materials 11 5.4 Dimensions 11 5.5 Marking 12 5.6 Statement of compliance 12 6 PROTECTIVE GLOVES . 13 6.1 General 13 6.2 Design . 13 6.3 Materials 13 6.4

25、 Dimensions 13 6.5 Marking 14 6.6 Statement of compliance 15 7 PROTECTIVE MITTENS . 15 7.1 General 15 7.2 Design . 15 7.3 Materials 15 7.4 Dimensions 15 7.5 Marking 16 7.6 Statement of compliance 16 8 PROTECTIVE GONAD APRONS 17 8.1 General 17 8.2 Design . 17 8.3 Materials 17 8.4 Dimensions 17 8.5 Ma

26、rking 17 8.6 Statement of compliance 18 IEC 61331-3:2014 IEC 2014 3 9 SCROTUM SHIELDS . 18 9.1 General 18 9.2 Design . 18 9.3 Materials 19 9.4 Dimensions 19 9.5 Marking 19 9.6 Statement of compliance 19 10 OVARY SHIELDS . 19 10.1 General 19 10.2 Design . 20 10.3 Materials 20 10.4 Dimensions 20 10.5

27、Marking 20 10.6 Statement of compliance 20 11 SHADOW SHIELDS 21 11.1 General 21 11.2 Design . 21 11.3 Materials 21 11.4 Dimensions 21 11.5 Marking 21 11.6 Statement of compliance 21 12 PROTECTIVE APRONS FOR DENTAL USE 22 12.1 General 22 12.2 Design . 22 12.3 Materials 22 12.4 Dimensions 22 12.5 Mark

28、ing 23 12.6 Statement of compliance 23 13 PROTECTIVE EYEWEAR . 23 13.1 General 23 13.2 Design . 23 13.3 Materials 24 13.4 Marking 24 13.5 Statement of compliance 24 Bibliography 25 Index of defined terms used in this standard 26 Figure 1 Inside dimensions of PROTECTIVE GLOVES 14 Figure 2 Inside mini

29、mum dimensions of PROTECTIVE MITTENS 16 Table 1 Information and examples for marking PROTECTIVE APRONS and THYROID COLLARS 12 Table 2 Standard sizes of PROTECTIVE GLOVES 14 Table 3 Information and examples for marking PROTECTIVE GLOVES 14 Table 4 Information and examples for marking PROTECTIVE MITTE

30、NS . 16 Table 5 Standard sizes of PROTECTIVE GONAD APRONS . 17 4 IEC 61331-3:2014 IEC 2014 Table 6 Information and examples for marking PROTECTIVE GONAD APRONS . 18 Table 7 Information and examples for marking SCROTUM SHIELDS . 19 Table 8 Information and examples for marking OVARY SHIELDS . 20 Table

31、 9 Information and examples for marking SHADOW SHIELDS 21 Table 10 Standard sizes of PROTECTIVE DENTAL APRONS 22 Table 11 Information and examples for marking PROTECTIVE APRONS 23 Table 12 Information and examples for marking PROTECTIVE EYEWEAR . 24 IEC 61331-3:2014 IEC 2014 5 INTERNATIONAL ELECTROT

32、ECHNICAL COMMISSION _ PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION Part 3: Protective clothing, eyewear and protective patient shields FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical

33、 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, Tec

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39、dicated 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 carried out by independent certification bodies.

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42、blication. 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

43、 such patent rights. International Standard IEC 61331-3 has been prepared by subcommittee 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 61331-3, published in 1998. It const

44、itutes a technical revision. This second edition has been adapted to apply to the present technology. It includes a requirement to use a better method for the determination of attenuation properties over a broader and more clinically relevant range of RADIATION QUALITIES appropriate to the use of th

45、e devices. It also covers three additional protective devices, THYROID COLLARS, PROTECTIVE EYEWEAR and PROTECTIVE APRONS FOR DENTAL USE. 6 IEC 61331-3:2014 IEC 2014 The text of this standard is based on the following documents: FDIS Report on voting 62B/938/FDIS 62B/944/RVD Full information on the v

46、oting 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 types are used: requirements and definitions: roman type; informative

47、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 used in this standard conform to usage described in Annex H of the I

48、SO/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

49、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 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 IE