BS EN 61331-2-2014 Protective devices against diagnostic medical X-radiation Translucent protective plates《防医疗诊断用X射线的防护装置 半透明防护板》.pdf

1、BSI Standards PublicationProtective devices against diagnostic medical X-radiationPart 2: Translucent protective platesBS EN 61331-2:2014National forewordThis British Standard is the UK implementation of EN 61331-2:2014. It isidentical to IEC 61331-2:2014. It supersedes BS EN 61331-2:2002, which wil

2、lbe withdrawn on 11 June 2017.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its secre

3、tary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 74634 5ICS 11.040.50; 13.280Compliance with a British Standard

4、cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 November 2014.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 61331-2:2014EUROPEAN STANDARD NORME EUROPENNE E

5、UROPISCHE NORM EN 61331-2 October 2014 ICS 11.040.50 Supersedes EN 61331-2:2002 English Version Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates (IEC 61331-2:2014) Dispositifs de protection radiologique contre les rayonnements X pour diagnostic mdical

6、 - Partie 2: Plaques translucides de protection radiologique (CEI 61331-2:2014) Strahlenschutz in der medizinischen Rntgendiagnostik - Teil 2: Durchsichtige Schutzplatten (IEC 61331-2:2014) This European Standard was approved by CENELEC on 2014-06-11. CENELEC members are bound to comply with the CEN

7、/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 CEN-CENELEC Management Cen

8、tre 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 CEN-CENELEC Management Centre has the same stat

9、us as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania

10、, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Nor

11、mung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 61331-2:2014 E BS EN 61331-2:2014EN 61331-2:2014 - 2 - Foreword The text of document 62B/937/FDIS, future edi

12、tion 2 of IEC 61331-2, 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 approved by CENELEC as EN 61331-2:2014. The following dates are fixed: latest date by which the document has to be i

13、mplemented at national level by publication of an identical national standard or by endorsement (dop) 2015-04-24 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2017-06-11 This document supersedes EN 61331-2:2002. Attention is drawn to the possibi

14、lity that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 61331-2:2014 was approved by CENELEC as a European Standa

15、rd without any modification. IEC 60601-2-17:2013 NOTE Harmonised as EN 60601-2-17:2014. BS EN 61331-2:2014- 3 - EN 61331-2:2014 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are nor

16、matively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified b

17、y common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Publication Year Title EN/HD Year IEC 60601-1 2005 Medical electrical equipment - Part 1: Gen

18、eral requirements for basic safety and essential performance EN 60601-1 2006 +EN 60601-1:2006/corrigendum Mar. 2010 2010 +AC 2014 +A11 2011 +A1 2012 +A1 2013 IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Stand

19、ard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 2008 +EN 60601-1-3:2008/corrigendum Mar. 2010 2010 +A1 2013 +A1 2013 +AC 2014 IEC 60601-2-8 2010 Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equip

20、ment operating in the range 10 kV to 1 MV FprEN 60601-2-8 2010 IEC 61331-1 2014 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials EN 61331-1 2014 ISO 3534-1 2006 Statistics_- Vocabulary and symbols_- Part_1: General statistical t

21、erms and terms used in probability - - IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - ISO/IEC Guide 99 2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM) - - BS EN 61331-2:2014 2 IEC 61331-2:2014 IEC 2014 CONTENTS 1 Scop

22、e 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 5.1 Inhomogeneities 7 5.2 Transmittance 7 6 ATTENUATION properties . 7 6.1 Determination of LEAD EQUIVAL

23、ENT 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 used in this International Standard 11 Table 1 Ratio of LEAD EQUIVALENT and minimum thickness for PROT

24、ECTIVE GLASS PLATES 8 Table 2 Information and data for marking PROTECTIVE GLASS PLATES . 8 BS EN 61331-2:2014IEC 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 PL

25、ATES used for RADIATION PROTECTION 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 RAD

26、IATION PROTECTION materials, e.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 acc

27、uracy; optical quality of the 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 applic

28、ation. For dated references, only 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 60601-1:20

29、05/AMD1:2012 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 IEC 60601-1-3:2008/AMD1:2013 IEC 60601-2-8:2010, Medical electrical equipment Part 2-8: Part

30、icular 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, Medical electrical equipment Glossary of defined terms BS EN 61331-2:2014 6 IEC 61331-2:2014 IEC 2014 IEC 61331-1:2014, Protective devices against dia

31、gnostic medical X-radiation Part 1: Determination of attenuation properties of materials ISO/IEC Guide 99:2007, International vocabulary of metrology Basic and general concepts and associated terms (VIM) ISO 3534-1:2006, Statistics Vocabulary and symbols Part 1: General statistical terms and terms u

32、sed in probability 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC/TR 60788:2004, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013, and the following apply. 3.1 PROTECTIVE GLASS PLATE TRANSLUCENT PR

33、OTECTIVE PLATE consisting of mineral glass with SPECIFIED attenuation properties used for manufacturing of optically clear and optically transparent protective shielding Note 1 to entry: Toughening impacts neither the attenuation properties nor optical and geometrical properties of the TRANSLUCENT P

34、ROTECTIVE PLATE consisting of mineral glass 3.2 PROTECTIVE PLASTIC PLATE TRANSLUCENT PROTECTIVE PLATE consisting of translucent plastic material with specified attenuation properties used for manufacturing of optically clear and optically transparent protective shielding 3.3 TRANSLUCENT PROTECTIVE P

35、LATE plate consisting of translucent material with SPECIFIED attenuation properties used for manufacturing of optically clear and optically transparent protective shielding 3.4 TRANSMITTANCE ratio of the transmitted radiant flux in the range of visible light to the incident flux in the range of visi

36、ble light in the given conditions Note 1 to entry: SI unit: 1. In the practice of the glass-industry it is usual to specify the transmittance in terms of %. SOURCE: IEC 60825-14:2004, 2.69, modified the definition has been modified to specify the “range of visible light“ and the note to entry has be

37、en expanded to address an aspect of the glass industry. 4 Geometrical accuracy of translucent protective plates 4.1 Flatness and minimum thickness On each of the two surfaces of a TRANSLUCENT PROTECTIVE PLATE all points shall be contained between two parallel planes 0,3 mm apart. The actual thicknes

38、s of a TRANSLUCENT PROTECTIVE PLATE shall not be less than the minimum thickness over its entire area. BS EN 61331-2:2014IEC 61331-2:2014 IEC 2014 7 The minimum thickness of TRANSLUCENT PROTECTIVE PLATES shall be indicated in units of millimetres (mm). NOTE The minimum thickness of the plate over it

39、s entire area is relevant for the effectiveness of RADIATION PROTECTION. 4.2 Edges The edges of PROTECTIVE GLASS PLATES shall be chamfered. 5 Optical quality of material 5.1 Inhomogeneities Streaks, bubbles, inhomogeneities and faults of the surface which prevent optical clarity should not occur. 5.

40、2 Transmittance PROTECTIVE GLASS PLATES shall have a TRANSMITTANCE equal to or greater than 80 % at a glass thickness of 10 mm for light of a wavelength of 550 nm. The UNCERTAINTY of test methods for determination of TRANSMITTANCE shall not exceed 2 %. This UNCERTAINTY applies to a CONFIDENCE LEVEL

41、of 95 %. 6 ATTENUATION properties 6.1 Determination of LEAD EQUIVALENT NOTE The RADIATION PROTECTION shielding needed for a special purpose is usually estimated in thickness of lead. Therefore it is necessary to know the LEAD EQUIVALENT of the TRANSLUCENT PROTECTIVE PLATE. The LEAD EQUIVALENT of a T

42、RANSLUCENT PROTECTIVE PLATE shall be determined and specified according to the methods described in IEC 61331-1. LEAD EQUIVALENT shall be measured by use of the NARROW BEAM CONDITION or BROAD BEAM CONDITION for appropriate standard RADIATION QUALITIES chosen from Tables 1 and 2 of IEC 61331-1. If a

43、measurement is not possible because of a lack of suitable radiation sources, e.g. for special photon-emitting RADIONUCLIDES, they shall be calculated according to the methods described in IEC 61331-1. The chosen condition shall be indicated according to 6.4 and Clause 7, whereby N stands for NARROW

44、BEAM CONDITION, B stands for BROAD BEAM CONDITION and C is used in case of calculated LEAD EQUIVALENT . Both conditions are allowed, but the end user has to decide which condition is the most suitable one for its application for RADIATION PROTECTION shielding. 6.2 Homogeneity The value of the LEAD E

45、QUIVALENT shall not be less than the specified value over the entire area of a TRANSLUCENT PROTECTIVE PLATE. 6.3 Minimum thickness and LEAD EQUIVALENT NOTE 1 TRANSLUCENT PROTECTIVE PLATES are usually ordered by their LEAD EQUIVALENT. Therefore it is useful to know the relation between a given minimu

46、m thickness and the corresponding LEAD EQUIVALENT. The ratio of the LEAD EQUIVALENT as determined according to 6.1 and the minimum thickness as determined according to 4.1 of a PROTECTIVE GLASS PLATE shall not be less than 0,22 for all RADIATION QUALITIES listed in Table 1 of IEC 61331-1 with X-RAY

47、TUBE VOLTAGES 50 kV to 150 kV. Examples of minimum thicknesses and their LEAD EQUIVALENT are given in Table 1. BS EN 61331-2:2014 8 IEC 61331-2:2014 IEC 2014 NOTE 2 The exact value of the ratio of the LEAD EQUIVALENT and the minimum thickness of a PROTECTIVE GLASS PLATE depends on the RADIATION QUAL

48、ITY. Table 1 Ratio of LEAD EQUIVALENT and minimum thickness for PROTECTIVE GLASS PLATES Minimum thickness mm LEAD EQUIVALENT mm Pb Ratio of LEAD EQUIVALENT and minimum thickness 3,5 0,77 0,22 5 1,10 0,22 6 1,32 0,22 7 1,54 0,22 8,5 1,87 0,22 10 2,20 0,22 6.4 Information Information about the LEAD EQ

49、UIVALENT shall be provided in mm Pb together with the method used for the determination and the RADIATION QUALITY or radionuclide for which it is SPECIFIED to be used. Either the information shall be provided in the form of ACCOMPANYING DOCUMENTS or it shall be ensured that the information can be obtained by using the marking according to Clause 7. If care must be taken in the use of cleaning agents, sufficient guidance for proper cleaning shall be contained in the ACCOMPANYING