EN 61331-1-2014 en Protective devices against diagnostic medical X-radiation - Part 1 Determination of attenuation properties of materials.pdf

1、BSI Standards PublicationProtective devices against diagnostic medical X-radiationPart 1: Determination of attenuation properties of materialsBS EN 61331-1:2014National forewordThis British Standard is the UK implementation of EN 61331-1:2014. It isidentical to IEC 61331-1:2014. It supersedes BS EN

2、61331-1:2002, which willbe withdrawn on 11 June 2017.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee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

3、 onrequest to its secretary.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 74633 8ICS 11.040.50; 13.280Compliance w

4、ith a British Standard 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 61331-1:2014EUROPEAN STA

5、NDARD NORME EUROPENNE EUROPISCHE NORM EN 61331-1 October 2014 ICS 11.040.50 Supersedes EN 61331-1:2002 English Version Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials (IEC 61331-1:2014) Dispositifs de protection radiologique co

6、ntre les rayonnements X pour diagnostic mdical - Partie 1: Dtermination des proprits dattnuation des matriaux (CEI 61331-1:2014) Strahlenschutz in der medizinischen Rntgendiagnostik - Teil 1: Bestimmung von Schwchungseigenschaften von Materialien (IEC 61331-1:2014) This European Standard was approve

7、d by CENELEC on 2014-06-11. CENELEC members are bound to comply with the CEN/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 nationa

8、l standards may be obtained on application to the CEN-CENELEC Management Centre 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

9、language and notified to the CEN-CENELEC Management Centre has the same status 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,

10、France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, 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

11、 Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung 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 61331-1:2014 E BS EN 61331-1:2014

12、EN 61331-1:2014 - 2 - Foreword The text of document 62B/936/FDIS, future edition 2 of IEC 61331-1, 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 61331-1:2014.

13、The following dates are fixed: latest date by which the document has to be implemented 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

14、 This document supersedes EN 61331-1:2002. Attention is drawn to the possibility 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 Internat

15、ional Standard IEC 61331-1:2014 was approved by CENELEC as a European Standard without any modification. IEC 61331-3 NOTE Harmonised as EN 61331-3. BS EN 61331-1:2014- 3 - EN 61331-1:2014 Annex ZA (normative) Normative references to international publications with their corresponding European public

16、ations The following documents, in whole or in part, are normatively 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.

17、NOTE 1 When an International Publication has been modified by 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

18、 IEC 60601-1 2005 Medical electrical equipment - Part 1: General 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 f

19、or basic safety and essential performance - Collateral Standard: 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/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 61331-1:

20、2014 2 IEC 61331-1:2014 IEC 2014 CONTENTS 1 Scope 6 2 Normative references 6 3 Terms and definitions 7 4 Methods to determine the ATTENUATION RATIO 7 4.1 General 7 4.2 NARROW BEAM CONDITION 7 4.2.1 General description 7 4.2.2 AIR KERMA RATE measurements . 7 4.2.3 RADIATION QUALITIES and RADIATION DE

21、TECTOR . 8 4.2.4 Signal to noise condition . 9 4.2.5 ATTENUATION RATIO evaluation. 10 4.3 BROAD BEAM CONDITION . 10 4.3.1 General description 10 4.3.2 AIR KERMA RATE measurements . 10 4.3.3 RADIATION QUALITIES and RADIATION DETECTOR . 10 4.3.4 Signal to noise condition . 11 4.3.5 ATTENUATION RATIO e

22、valuation . 12 4.4 Inverse BROAD BEAM CONDITION . 12 4.4.1 General description 12 4.4.2 AIR KERMA RATE measurements . 12 4.4.3 RADIATION QUALITIES and RADIATION DETECTOR . 13 4.4.4 Signal to noise condition . 14 4.4.5 ATTENUATION RATIO evaluation . 14 4.5 Calculation of the ATTENUATION RATIO for pho

23、ton-emitting radionuclides . 14 4.5.1 Equation . 14 4.5.2 Decay data . 14 4.5.3 Mass ATTENUATION and mass energy-absorption coefficients 14 4.5.4 Verification of the mass- ATTENUATION COEFFICIENTS of the test material 15 5 Determination of ATTENUATION properties . 16 5.1 ATTENUATION RATIO . 16 5.1.1

24、 Determination . 16 5.1.2 Indication 16 5.2 BUILD-UP FACTOR . 16 5.2.1 Determination . 16 5.2.2 Indication 16 5.3 ATTENUATION EQUIVALENT 16 5.3.1 Determination . 16 5.3.2 Indication 17 5.4 LEAD EQUIVALENT 17 5.4.1 Determination . 17 5.4.2 Indication 17 5.5 LEAD EQUIVALENT class for a SPECIFIED range

25、 of RADIATION QUALITIES 17 5.5.1 Materials. 17 5.5.2 Standard thicknesses . 17 BS EN 61331-1:2014IEC 61331-1:2014 IEC 2014 3 5.5.3 Conditions for assignment to a LEAD EQUIVALENT class 17 5.5.4 Indication 18 5.6 Homogeneity 18 5.6.1 Determination . 18 5.6.2 Indication 18 6 Statement of compliance . 1

26、8 Annex A (informative) Tables of ATTENUATION RATIOS, BUILD-UP FACTORS and first HALF-VALUE LAYERS 19 Bibliography 24 Index of defined terms used in this International Standard 25 Figure 1 NARROW BEAM CONDITION 9 Figure 2 BROAD BEAM CONDITION . 11 Figure 3 Inverse BROAD BEAM CONDITION . 13 Table 1 S

27、tandard RADIATION QUALITIES for X-RAY BEAMS 15 Table 2 Standard gamma RADIATION QUALITIES according to ISO 4037-1 . 16 Table A.1 ATTENUATION RATIOS FNof lead thicknesses from 0,125 mm to 2 mm calculated for RADIATION QUALITIES of Table 1 according to the formula given in 4.5.4 20 Table A.2 BUILD-UP

28、FACTOR B measured for RADIATION QUALITIES of Table 1 according to the formula given in 5.2.1 for lead thicknesses 0,25 mm, 0,35 mm and 0,50 mm . 21 Table A.3 ATTENUATION RATIOS FNof lead thicknesses from 0,125 mm to 7 mm calculated for RADIATION QUALITIES of Tables 1 and 2 according to the formula g

29、iven in 4.5.4 . 21 Table A.4 First HALF-VALUE LAYERS in mm Al of RADIATION QUALITIES of Table 1 as a function of additional lead filters of different thicknesses in the range from 0,125 mm to 2 mm 22 Table A.5 First HALF-VALUE LAYERS in mm Cu of RADIATION QUALITIES of Table 1 as a function of additi

30、onal lead filters of different thicknesses in the range from 0,125 mm to 4 mm 23 BS EN 61331-1:2014 6 IEC 61331-1:2014 IEC 2014 PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION Part 1: Determination of attenuation properties of materials 1 Scope This part of IEC 61331 applies to materials i

31、n sheet form used for the manufacturing of PROTECTIVE DEVICES against X-RADIATION of RADIATION QUALITIES generated with X-RAY TUBE VOLTAGES up to 400 kV and gamma radiation emitted by radionuclides with photon energies up to 1,3 MeV. This Part 1 is not intended to be applied to PROTECTIVE DEVICES wh

32、en these are to be checked for the presence of their ATTENUATION properties before and after periods of use. This Part 1 specifies the methods of determining and indicating the ATTENUATION properties of the materials. The ATTENUATION properties are given in terms of: ATTENUATION RATIO; BUILD-UP FACT

33、OR; ATTENUATION EQUIVALENT; together with, as appropriate, an indication of homogeneity and mass per unit area. Ways of stating values of ATTENUATION properties in compliance with this part of the International Standard are included. Excluded from the scope of this International Standard are: method

34、s for periodical checks of PROTECTIVE DEVICES, particularly of PROTECTIVE CLOTHING, methods of determining ATTENUATION by layers in the RADIATION BEAM, and methods of determining ATTENUATION for purposes of protection against IONIZING RADIATION provided by walls and other parts of an installation. 2

35、 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, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendm

36、ents) 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 60601-1-3:2008, Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral Stand

37、ard: Radiation protection in diagnostic X-ray equipment IEC 60601-1-3:2008/AMD1:2013 IEC/TR 60788:2004, Medical electrical equipment Glossary of defined terms BS EN 61331-1:2014IEC 61331-1:2014 IEC 2014 7 Monographie BIPM-5:2013, Table of Radionuclides1NISTIR 5632:2004, Tables of X-Ray Mass Attenuat

38、ion Coefficients and Mass Energy-Absorption Coefficients (version 1.4) on-line, cited 2014-01-30 Available at http:/www.nist.gov/pml/data/xraycoef/23 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/A

39、MD 1:2012, IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 and the following apply. 3.1 ATTENUATION RATIO ratio of the value of a SPECIFIED RADIATION QUANTITY in the centre of a SPECIFIED RADIATION BEAM of SPECIFIED RADIATION QUALITY, with the attenuating material under consideration outside the

40、 beam, to the value at the same position and under the same conditions with this attenuating material placed in the beam 4 Methods to determine the ATTENUATION RATIO 4.1 General There are four different conditions described in this standard to determine ATTENUATION RATIOS, F: FNATTENUATION RATIO mea

41、sured with a NARROW BEAM CONDITION (4.2) FBATTENUATION RATIO measured with a BROAD BEAM CONDITION (4.3) FIBATTENUATION RATIO measured with an inverse BROAD BEAM CONDITION (4.4) FN,RATTENUATION RATIO calculated for a photon-emitting radionuclide, R (4.5) 4.2 NARROW BEAM CONDITION 4.2.1 General descri

42、ption The ATTENUATION RATIO FNfor a given test material (or test object) shall be measured according to the arrangement for NARROW BEAM CONDITION as shown in Figure 1. This arrangement is designed to measure the ATTENUATION of the X-RAY BEAM only due to primary photons. The probability that secondar

43、y photons such as fluorescence photons or Compton scattered photons from the test object reach the RADIATION DETECTOR is minimized. The aperture in the DIAPHRAGM shall be just large enough to produce the smallest beam covering the radiation detector. An additional DIAPHRAGM (number 5 in Figure 1) sh

44、all be used to shield the RADIATION DETECTOR from SCATTERED RADIATION produced in the test object. The distance a from the test object to the reference point of the RADIATION DETECTOR on the beam axis shall be at least ten times the diameter d of the detector or ten times the diameter t of the RADIA

45、TION BEAM at the distal surface of the test object , whatever is larger, i.e. a 10 max(d,t). The minimal distance of the wall or the floor from the detector (position 6 in the Figure 1) in the direction of the beam shall be 700 mm. 4.2.2 AIR KERMA RATE measurements The AIR KERMA RATE shall be measur

46、ed under three different conditions with the same RADIATION DETECTOR at the same position, where _ 1Bureau International de Poids et Mesures, Pavillon de Breteeuil, F-92310 Svres, ISBN 92-822-2204-7 (set). 2National Institute of Standards and Technology (NIST), U.S.Department of Commerce. BS EN 6133

47、1-1:2014 8 IEC 61331-1:2014 IEC 2014 0Kdenotes the AIR KERMA RATE without the test object in the RADIATION BEAM; 1Kthe AIR KERMA RATE with the test object in the RADIATION BEAM; BKthe AIR KERMA RATE with the test object in the beam replaced by a sheet of material of the same shape with an ATTENUATIO

48、N RATIO greater than 105.The same constant dose rate of the primary beam shall be used for the three measurements. If the mean dose rate of the primary beam varies by more than 0,2 % during the measurements, a monitor shall be used to normalize the three measurements to the same primary beam dose ra

49、te. 4.2.3 RADIATION QUALITIES and RADIATION DETECTOR The RADIATION QUALITIES used for the measurements shall be selected from Table 1 . The RADIATION DETECTOR shall be calibrated in terms of AIR KERMA. The quotient 0Kdivided by 1Kshall be known with a relative standard uncertainty not more than 2 %. NOTE The AIR KERMA RESPONSE of the RADIATION DETECTOR can be measured with e.g. NARROW BEAM qualities and the RESPONSE can be plotted as a function of Al or Cu H