EN IEC 62667-2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Medical electrical equipment - Medical light ion beam equipment - Performance characteristics (IEC 62667:2017)BS EN IEC 62667:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN IEC 62667 April 2018 ICS 11.040.60 E

2、nglish Version Medical electrical equipment - Medical light ion beam equipment - Performance characteristics (IEC 62667:2017) Appareils lectromdicaux - Appareils mdicaux par faisceau dions lgers - Caractristiques de performances (IEC 62667:2017) Medizinische elektrische Gerte - Medizinische Leichtio

3、nen-Bestrahlungseinrichtungen - Leistungsmerkmale (IEC 62667:2017) This European Standard was approved by CENELEC on 2017-09-27. 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 sta

4、ndard without any alteration. Up-to-date lists and bibliographical references concerning such national 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

5、 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 status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cr

6、oatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzer

7、land, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CENELEC All rights of exploitation i

8、n any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN IEC 62667:2018 E National forewordThis British Standard is the UK implementation of EN IEC 62667:2018. It is identical to IEC 62667:2017.The UK participation in its preparation was entrusted to Technical Committee CH/62/

9、3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct app

10、lication. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 70599 1ICS 11.040.60Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Com

11、mittee on 30 April 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN IEC 62667:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN IEC 62667 April 2018 ICS 11.040.60 English Version Medical electrical equipment - Medical light ion beam equipment - Perfor

12、mance characteristics (IEC 62667:2017) Appareils lectromdicaux - Appareils mdicaux par faisceau dions lgers - Caractristiques de performances (IEC 62667:2017) Medizinische elektrische Gerte - Medizinische Leichtionen-Bestrahlungseinrichtungen - Leistungsmerkmale (IEC 62667:2017) This European Standa

13、rd was approved by CENELEC on 2017-09-27. 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 concernin

14、g such national 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

15、 into its own 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

16、of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardiz

17、ation Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN IEC 626

18、67:2018 E BS EN IEC 62667:2018EN IEC 62667:2018 (E) 2 European foreword The text of document 62C/693/FDIS, future IEC 62667, prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENE

19、LEC parallel vote and approved by CENELEC as EN IEC 62667:2018. 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) 2018-10-20 latest date by which the national standards con

20、flicting with the document have to be withdrawn (dow) 2021-04-20 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text of t

21、he International Standard IEC 62667:2017 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-2-11:2013 NOTE Harmonized as EN 60601-2-11:2015. IEC 60601-2-17:201

22、3 NOTE Harmonized as EN 60601-2-17:2015. IEC 60601-2-68:2014 NOTE Harmonized as EN 60601-2-68:2015. IEC 60731:2011 NOTE Harmonized as EN 60731:2012. IEC 60976:2007 NOTE Harmonized as EN 60976:2007. IEC 61223-3-5:2004 NOTE Harmonized as EN 61223-3-5:2004. IEC 61267:2005 NOTE Harmonized as EN 61267:20

23、06. IEC 62083:2009 NOTE Harmonized as EN 62083:2009. IEC 62220-1-1:2015 NOTE Harmonized as EN 62220-1-1:2015. IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015. BS EN IEC 62667:2018EN IEC 62667:2018 (E) 3 Annex ZA (normative) Normative references to international publications with their correspond

24、ing European publications The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includ

25、ing any amendments) applies. NOTE 1 Where 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. Pub

26、lication Year Title EN/HD Year IEC 60580 2000 Medical electrical equipment - Dose area product meters EN 60580 2000 IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 +A1 2012 +A1 2013 IEC 60601-2-1 2009 Medical ele

27、ctrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV EN 60601-2-1 2015 +A1 2014 - - IEC 60601-2-64 2014 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and ess

28、ential performance of light ion beam medical equipment EN 60601-2-64 2015 IEC 61217 2011 Radiotherapy equipment - Coordinates, movements and scales EN 61217 2012 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN IEC 62667:2018This page deliberately left blank 2 IEC

29、 62667:2017 IEC 2017 CONTENTS FOREWORD . 6 INTRODUCTION . 8 1 Scope 9 2 Normative references 9 3 Terms and definitions 10 4 Environmental conditions . 17 4.1 General . 17 4.2 Transport and storage . 18 4.3 Facility stability . 18 5 Presentation of information to the USER . 18 5.1 General . 18 5.2 In

30、tended parameters . 18 6 Beam delivery 18 6.1 LIGHT ION species 18 6.2 Energy 18 6.2.1 Method of selection of ENERGY PER NUCLEON or LIGHT ION BEAM RANGE 18 6.2.2 Range of available ENERGIES PER NUCLEON or LIGHT ION BEAM RANGES . 18 6.2.3 Methods of ensuring the ENERGY PER NUCLEON OR LIGHT ION BEAM R

31、ANGE 19 6.2.4 Accuracy of ENERGY PER NUCLEON or LIGHT ION BEAM RANGE 19 6.3 BEAM GATING . 19 6.3.1 Method of BEAM GATING 19 6.3.2 BEAM GATING required input trigger . 19 6.4 GANTRIES 19 6.4.1 GANTRY types 19 6.4.2 GANTRY configurations . 19 6.4.3 GANTRY angle readout . 20 6.5 APPLICATOR CARRIAGE 20

32、6.6 LIGHT ION BEAM APPLICATORS 20 6.7 Adjustable BEAM LIMITING DEVICES (BLDS) . 20 6.7.1 Information to the USER 20 6.7.2 Test . 21 6.8 ISOCENTRE . 21 6.8.1 Information to the USER 21 6.8.2 Test . 22 6.9 LATERAL SPREADING DEVICES (LSDs) 22 6.9.1 Type and order of lateral SPREADING DEVICES in the RAD

33、IATION HEAD . 22 6.9.2 SCANNING MODES for laterally spreading the beam 23 6.9.3 UNIFORM SCANNING . 23 6.9.4 Synchronization types for scanning the beam 23 6.9.5 VIRTUAL SOURCE-TO-AXIS DISTANCES (VSADS) . 23 6.10 Time constraints . 24 6.10.1 General . 24 6.10.2 Maximum IRRADIATION TIME 24 6.10.3 Time

34、 to switch between IRRADIATIONS in different rooms 24 6.10.4 Time to switch beam between RADIATION HEADS with a common ERP 25 6.10.5 Time to switch between two ENERGY PER NUCLEON levels 25 2 IEC 62667:2017 IEC 2017 CONTENTS FOREWORD . 6 INTRODUCTION . 8 1 Scope 9 2 Normative references 9 3 Terms and

35、 definitions 10 4 Environmental conditions . 17 4.1 General . 17 4.2 Transport and storage . 18 4.3 Facility stability . 18 5 Presentation of information to the USER . 18 5.1 General . 18 5.2 Intended parameters . 18 6 Beam delivery 18 6.1 LIGHT ION species 18 6.2 Energy 18 6.2.1 Method of selection

36、 of ENERGY PER NUCLEON or LIGHT ION BEAM RANGE 18 6.2.2 Range of available ENERGIES PER NUCLEON or LIGHT ION BEAM RANGES . 18 6.2.3 Methods of ensuring the ENERGY PER NUCLEON OR LIGHT ION BEAM RANGE 19 6.2.4 Accuracy of ENERGY PER NUCLEON or LIGHT ION BEAM RANGE 19 6.3 BEAM GATING . 19 6.3.1 Method

37、of BEAM GATING 19 6.3.2 BEAM GATING required input trigger . 19 6.4 GANTRIES 19 6.4.1 GANTRY types 19 6.4.2 GANTRY configurations . 19 6.4.3 GANTRY angle readout . 20 6.5 APPLICATOR CARRIAGE 20 6.6 LIGHT ION BEAM APPLICATORS 20 6.7 Adjustable BEAM LIMITING DEVICES (BLDS) . 20 6.7.1 Information to th

38、e USER 20 6.7.2 Test . 21 6.8 ISOCENTRE . 21 6.8.1 Information to the USER 21 6.8.2 Test . 22 6.9 LATERAL SPREADING DEVICES (LSDs) 22 6.9.1 Type and order of lateral SPREADING DEVICES in the RADIATION HEAD . 22 6.9.2 SCANNING MODES for laterally spreading the beam 23 6.9.3 UNIFORM SCANNING . 23 6.9.

39、4 Synchronization types for scanning the beam 23 6.9.5 VIRTUAL SOURCE-TO-AXIS DISTANCES (VSADS) . 23 6.10 Time constraints . 24 6.10.1 General . 24 6.10.2 Maximum IRRADIATION TIME 24 6.10.3 Time to switch between IRRADIATIONS in different rooms 24 6.10.4 Time to switch beam between RADIATION HEADS w

40、ith a common ERP 25 6.10.5 Time to switch between two ENERGY PER NUCLEON levels 25 BS EN IEC 62667:2018IEC 62667:2017 IEC 2017 3 6.10.6 Time to switch between two LIGHT ION species . 25 6.10.7 Time to TERMINATE and INTERRUPT IRRADIATION . 26 6.10.8 Time to restart IRRADIATION 26 6.10.9 Start-up time

41、 26 6.10.10 Time for shutdown . 26 6.11 Maintenance . 27 7 DOSE MONITORING SYSTEM 27 7.1 General . 27 7.2 Standard test conditions for testing DOSE MONITORING SYSTEMS . 27 7.3 Reproducibility of MU delivery . 27 7.3.1 Information to the USER 27 7.3.2 Test . 27 7.4 Proportionality of MU delivery . 28

42、 7.4.1 Requirement 28 7.4.2 Information to the USER 29 7.4.3 Test . 29 7.5 Off-axis response of beam FLUX monitor for MODULATED SCANNING . 30 7.5.1 Information to the USER 30 7.5.2 Test . 30 7.6 Dependence of MU delivery on angular position 31 7.6.1 Information to the USER 31 7.6.2 Test . 31 7.7 Sta

43、bility of MU DELIVERY . 32 7.7.1 Stability of MU DELIVERY throughout the day . 32 7.7.2 Stability of MU DELIVERY throughout the week . 33 8 DEPTH DOSE characteristics 34 8.1 DEPTH DOSE distributions for NON-RANGE MODULATED PORTALS 34 8.1.1 Information to the USER 34 8.1.2 Test . 34 8.2 Range modulat

44、ing techniques . 35 8.2.1 Type and sequence of range MODULATION DEVICES in RADIATION HEAD . 35 8.2.2 Discrete RANGE MODULATION DEVICE 35 8.2.3 Programmable RANGE MODULATION DEVICE 35 8.3 RANGE MODULATED PORTAL DEPTH DOSE distributions 36 8.3.1 Information to the USER 36 8.3.2 Test . 36 8.4 Stability

45、 OF LIGHT ION BEAM RANGE 37 8.4.1 Stability of LIGHT ION BEAM RANGE throughout an IRRADIATION 37 8.4.2 Dependence of LIGHT ION BEAM RANGE on GANTRY rotation 37 9 Lateral profiles of LIGHT ION PORTALS 38 9.1 Lateral profiles of LIGHT ION PORTALS for systems that use scatterers or UNIFORM SCANNING . 3

46、8 9.1.1 General . 38 9.1.2 Flatness of LIGHT ION PORTALS 39 9.1.3 Symmetry of LIGHT ION PORTALS 39 9.1.4 Lateral PENUMBRA 40 9.2 Lateral profiles of LIGHT ION PORTALS for systems that use MODULATED SCANNING 40 BS EN IEC 62667:2018 4 IEC 62667:2017 IEC 2017 9.2.1 Information to the USER 40 9.2.2 Test

47、 . 40 10 LIGHT ION PORTAL with energy and FLUENCE modulation (EFM) . 41 10.1 Information to the USER . 41 10.2 Beam characteristics and dosimetry system performance for small delivered doses 41 11 Time to irradiate SPECIFIED volumes . 41 11.1 Information to the USER . 41 11.2 Test 42 12 Indication o

48、f RADIATION FIELDS 42 12.1 APPLICATOR CARRIAGE extension indicator 42 12.1.1 Information to the USER 42 12.1.2 Test . 42 12.2 Multi-element BLD element position indications 42 12.2.1 Information to the USER 42 12.2.2 Test . 42 12.3 Indication of THE LIGHT ION REFERENCE AXIS 43 12.3.1 General . 43 12

49、3.2 Indication on entry to the PATIENT 43 12.3.3 Indication of the LIGHT ION REFERENCE AXIS on distal side of PATIENT . 44 12.4 LIGHT FIELD-indicator . 44 12.4.1 Information to USER 44 12.4.2 Test . 44 13 PATIENT SUPPORTS . 45 13.1 General . 45 13.2 TABLE TOPS . 45 13.2.1 General . 45 13.2.2 Available TABLE TOPS . 45 13.2.3 Extent of movements of TABLE TOP relative to PATIENT SUPPORT 45 13.2.4 Positional deviation of the TABLE TOP surface during longitudinal motion 46 13.2.5 Positional deviation of the TABLE TOP surface durin