1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationRadiotherapy equipment Coordinates, movements andscalesBS EN 61217:2012National forewordThis British Standard is the UK implementation of EN 61217:2012. It is identical to IEC 61
2、217:2011. It supersedes BS EN 61217:1996+A2:2008, which will be withdrawn on 11 January 2015.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiati
3、on 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 application. The British Standards Institution 2012Published b
4、y BSI Standards Limited 2012 ISBN 978 0 580 68518 7 ICS 11.040.50; 13.280Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2012.Amendments issued since pub
5、licationAmd. No. Date Text affectedBRITISH STANDARDBS EN 61217:2012EUROPEAN STANDARD EN 61217 NORME EUROPENNE EUROPISCHE NORM April 2012 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Ma
6、nagement Centre: Avenue Marnix 17, B - 1000 Brussels 2012 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61217:2012 E ICS 11.040.50; 13.280 Supersedes EN 61217:1996 + A1:2001 + A2:2008English version Radiotherapy equipment - Coor
7、dinates, movements and scales (IEC 61217:2011) Appareils utiliss en radiothrapie - Coordonnes, mouvements et chelles (CEI 61217:2011) Strahlentherapie-Einrichtungen -Koordinaten, Bewegungen und Skalen (IEC 61217:2011) This European Standard was approved by CENELEC on 2012-01-11. CENELEC members are
8、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 national standards may be obtained on application to th
9、e 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 language and notified to the CEN-CENELEC Managem
10、ent 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembour
11、g, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 61217:2012EN 61217:2012 - 2 - Foreword The text of document 62C/530/FDIS, future edition 2 of IEC 61217, prepared by SC 62C, “Equipment for radiotherapy,
12、 nuclear medicine and radiation dosimetry“, of IEC/TC 62, “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61217:2012. The following dates are fixed: latest date by which the document has to be implemented at national level by pu
13、blication of an identical national standard or by endorsement (dop) 2012-10-11 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2015-01-11 This document supersedes EN 61217:1996 + A1:2001 + A2:2008. EN 61217:2012 constitutes a technical revision to
14、 include imager and focus coordinate systems in 3.12. Beyond this subclause, changes were only introduced where needed to include the above coordinate systems. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informativ
15、e 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 USED THROUGHOUT THIS STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED TERMS: SMALL CAPITALS. The verbal forms used in this standard conform
16、 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 requirement or a test is recommend
17、ed 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. 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
18、be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive(s) se
19、e informative Annex ZZ, which is an integral part of this document. BS EN 61217:2012- 3 - EN 61217:2012 Endorsement notice The text of the International Standard IEC 61217:2011 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the fol
20、lowing notes have to be added for the standards indicated: IEC 60976:2007 NOTE Harmonized as EN 60976:2007 (not modified). IEC 61168:1993 NOTE Harmonized as EN 61168:1994 (not modified). BS EN 61217:2012EN 61217:2012 - 4 - Annex ZA (normative) Normative references to international publications with
21、their corresponding European publications 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 (
22、including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60601-1 + corr. December + corr. December 2005 2006 2007 Medical electrical equipment - Part 1: G
23、eneral requirements for basic safety and essential performance EN 60601-1 + corr. March + A11 2006 2010 2011 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 equ
24、ipment EN 60601-1-3 + corr. March 2008 2010 IEC 60601-2-1 2009 Medical electrical 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 201X1)IEC 60601-2-11 1997 Medical electrical equipment - P
25、art 2-11: Particular requirements for the safety of gamma beam therapy equipment EN 60601-2-11 1997 IEC 60601-2-29 2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators EN 60601-2-29 + A11 2008 2011 IEC/TR 607
26、88 2004 Medical electrical equipment - Glossary of defined terms - - IEC 62083 2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems EN 62083 2009 1)To be published. BS EN 61217:2012- 5 - EN 61217:2012 Annex ZZ (informative) Coverage of Essential
27、Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers the relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC fo
28、r ERs 9.1 and 11.2.1 last sentence only. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standar
29、d. BS EN 61217:2012 2 61217 IEC:2011 CONTENTS INTRODUCTION . 8 1 Scope and object 10 2 Normative references . 10 3 Coordinate systems 10 3.1 General . 10 3.2 General rules 11 3.3 Fixed reference system (“f“) (Figure 1a) 12 3.4 GANTRY coordinate system (“g“) (Figure 4) . 12 3.5 BEAM LIMITING DEVICE o
30、r DELINEATOR coordinate system (“b“) (Figure 5) . 13 3.6 WEDGE FILTER coordinate system (“w“) (Figure 7) 13 3.7 X-RAY IMAGE RECEPTOR coordinate system (“r“) (Figures 6 and 8) 14 3.8 PATIENT SUPPORT coordinate system (“s“) (Figure 9) 14 3.9 Table top eccentric rotation coordinate system (“e“) (Figure
31、s 10 and 11) . 15 3.10 Table top coordinate system (“t“) (Figures 10, 11, 18 and 19) 15 3.11 PATIENT coordinate system (“p“) (Figures 17a and 17b) . 16 3.12 Imager coordinate system (“i“) and focus coordinate system (“o“) . 17 3.12.1 General . 17 3.12.2 The imager coordinate system (“i“) 17 3.12.3 F
32、ocus coordinate system (“o“) . 18 4 Identification of scales and digital DISPLAYS . 18 5 Designation of ME EQUIPMENT movements . 19 6 ME EQUIPMENT zero positions 19 7 List of scales, graduations, directions and DISPLAYS . 20 7.1 General . 20 7.2 Rotation of the GANTRY (Figures 14a and 14b) 20 7.3 Ro
33、tation of the BEAM LIMITING DEVICE or DELINEATOR (Figures 15a and 15b) . 20 7.4 Rotation of the WEDGE FILTER (Figures 7 and 14a) . 20 7.5 RADIATION FIELD or DELINEATED RADIATION FIELD 21 7.5.1 General . 21 7.5.2 Edges of RADIATION FIELD or DELINEATED RADIATION FIELD (Figure 16a) 21 7.5.3 DISPLAY of
34、RADIATION FIELD or DELINEATED RADIATION FIELD (Figures 16a to 16k) 22 7.6 PATIENT SUPPORT isocentric rotation 23 7.7 Table top eccentric rotation . 23 7.8 Table top linear and angular movements . 24 7.8.1 Vertical displacement of the table top 24 7.8.2 Longitudinal displacement of the table top . 24
35、 7.8.3 Lateral displacement of the table top . 24 7.8.4 Pitch of the table top . 24 7.8.5 Roll of the table top . 24 7.9 X-RAY IMAGE RECEPTOR movements 24 7.9.1 X-RAY IMAGE RECEPTOR rotation 24 7.9.2 X-RAY IMAGE RECEPTOR radial displacement from RADIATION SOURCE (SID) . 25 7.9.3 X-RAY IMAGE RECEPTOR
36、 radial displacement from ISOCENTRE 25 BS EN 61217:201261217 IEC:2011 3 7.9.4 X-RAY IMAGE RECEPTOR longitudinal displacement . 25 7.9.5 X-RAY IMAGE RECEPTOR lateral displacement . 25 7.10 Other scales 25 Annex A (informative) Examples of coordinate transformations between individual coordinate syste
37、ms . 57 Annex B (informative) Coordinate transformations between IEC and DICOM PATIENT coordinates . 64 Bibliography 65 Index of defined terms 66 Figure 1a Coordinate systems for an isocentric RADIOTHERAPY EQUIPMENT (see 3.1) with all angular positions set to zero . 27 Figure 1b Translation of origi
38、n Id along Xm, Ym, Zm and rotation around axis Zd parallel to Zm (see 3.2d) 28 Figure 1c Translation of origin Id along Xm, Ym, Zm and rotation around axis Yd parallel to Ym (see 3.2d) . 28 Figure 2 X Y Z right-hand coordinate mother system (isometric drawing) showing , , directions of positive rota
39、tion for daughter system (see 3.2a) 29 Figure 3 Hierarchical structure among coordinate systems (see 3.2c) and 3.2e) . 30 Figure 4 Rotation (g = 15) of GANTRY coordinate system Xg, Yg, Zg in fixed coordinate system Xf, Yf, Zf (see 3.4) . 31 Figure 5 Rotation (b = 15) of BEAM LIMITING DEVICE or DELIN
40、EATOR coordinate system Xb, Yb, Zb in GANTRY coordinate system Xg, Yg, Zg, and resultant rotation of RADIATION FIELD or DELINEATED RADIATION FIELD of dimensions FX and FY (see 3.5) . 32 Figure 6 Displacement of image intensifier type X-RAY IMAGE RECEPTOR coordinate system origin, Ir, in GANTRY coord
41、inate system, by Rx = 8, Ry = +10, Rz = 40 (see 3.7) . 33 Figure 7 Rotation (w = 270) and translation of WEDGE FILTER coordinate system Xw, Yw, Zw in BEAM LIMITING DEVICE coordinate system Xb, Yb, Zb, the BEAM LIMITING DEVICE coordinate system having a rotation b = 345 (see 3.6) . 34 Figure 8 Rotati
42、on (r = 90) and displacement of X-RAYIMAGE RECEPTOR coordinate system Xr, Yr, Zr in GANTRY coordinate system Xg, Yg, Zg (see 3.7) 35 Figure 9 Rotation (s = 345) of PATIENT SUPPORT coordinate system Xs, Ys, Zs in fixed coordinate system Xf, Yf, Zf (see 3.8) . 36 Figure 10 Table top eccentric coordina
43、te system rotation e in PATIENT SUPPORT coordinate system which has been rotated by s in the fixed coordinate system with e = 360 s (see 3.9 and 3.10) . 37 Figure 11a Table top displaced below ISOCENTRE by Tz = 20 cm (see 3.9 and 3.10) . 37 Figure 11b Table top coordinate system displacement Tx = +
44、5, Ty = Le + 10 in PATIENT SUPPORT coordinate system Xs, Ys, Zs rotation (s = 330) in fixed coordinate system Xf, Yf, Zf (see 3.9 and 3.10) 38 Figure 11c Table top coordinate system rotation (e = 30) about table top eccentric system. PATIENT SUPPORT rotation (s = 330) in fixed coordinate system Tx =
45、 0, Ty = Le (see 3.9 and 3.10) 38 Figure 12a Example of BEAM LIMITING DEVICE scale, pointer on mother system (GANTRY), scale on daughter system (BEAM LIMITING DEVICE), viewed from ISOCENTRE (see 3.2f)2) and Clause 4) . 39 Figure 12b Example of BEAM LIMITING DEVICE scale, pointer on daughter system (
46、BEAM LIMITING DEVICE), scale on mother system (GANTRY), viewed from ISOCENTRE (see 3.2f)2) and Clause 4) 40 BS EN 61217:2012 4 61217 IEC:2011 Figure 12c Examples of scales (see Clause 4) . 40 Figure 13a Rotary GANTRY (adapted from IEC 60601-2-1) with identification of axes 1 to 8, directions 9 to 13
47、, and dimensions 14 and 15 (see Clause 5) . 41 Figure 13b ISOCENTRIC RADIOTHERAPY SIMULATOR or TELERADIOTHERAPY EQUIPMENT, with identification of axes 1; 4 to 6; 19, of directions 9 to 12; 16 to 18 and of dimensions 14; 15 (see Clause 5) . 42 Figure 13c View from radiation source of teleradiotherapy
48、 radiation field or radio-therapy simulator delineated radiation field (see Clause 5) . 43 Figure 14a Example of ISOCENTRIC TELERADIOTHERAPY EQUIPMENT (see 7.2 and 7.4) . 44 Figure 14b Example of ISOCENTRIC RADIOTHERAPY SIMULATOR equipment (see 7.2) . 45 Figure 15a Rotated (b = 30) symmetrical recta
49、ngular RADIATION FIELD (FX FY) at NORMAL TREATMENT DISTANCE, viewed from ISOCENTRE looking toward RADIATION SOURCE (see 7.3) . 46 Figure 15b Same rotated (b = 30) symmetrical rectangular RADIATION FIELD (FX FY) at NORMAL TREATMENT DISTANCE, viewed from RADIATION SOURCE (see 7.3) 46 Figure 16a Rectangular and symmetrical RADIATION FIELD or DELINEATED RADIATION FIELD, viewed from RADIATION SOURCE (see 7.5) . 47 Figure 16b Rectan
