EN 61217:2012

SLOVENSKI STANDARD
01-julij-2012
Oprema za radioterapijo - Koordinate, gibanje in skale
Radiotherapy equipment - Coordinates, movements and scales
Strahlentherapie-Einrichtungen - Koordinaten, Bewegungen und Skalen
Appareils utilisés en radiothérapie - Coordonnées, mouvements et échelles
Ta slovenski standard je istoveten z: EN 61217:2012
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 61217
NORME EUROPÉENNE
April 2012
EUROPÄISCHE NORM
ICS 11.040.50; 13.280 Supersedes EN 61217:1996 + A1:2001 + A2:2008

English version
Radiotherapy equipment -
Coordinates, movements and scales
(IEC 61217:2011)
Appareils utilisés en radiothérapie -  Strahlentherapie-Einrichtungen -
Coordonnées, mouvements et échelles Koordinaten, Bewegungen und Skalen
(CEI 61217:2011) (IEC 61217:2011)

This European Standard was approved by CENELEC on 2012-01-11. 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 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 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, 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.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management 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
Foreword
The text of document 62C/530/FDIS, future edition 2 of IEC 61217, 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-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
(dop) 2012-10-11
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2015-01-11

standards conflicting with the
document have to be withdrawn
This document supersedes EN 61217:1996 + A1:2001 + A2:2008.
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.
– Informative 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 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 recommended 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 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) see informative Annex ZZ, which is an integral part of this
document.
- 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 following 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).

Annex ZA
(normative)
Normative references to international publications
with 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 (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 2005 Medical electrical equipment - EN 60601-1 2006
+ corr. December 2006 Part 1: General requirements for basic safety + corr. March 2010
+ corr. December 2007 and essential performance + A11 2011

IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
1)
IEC 60601-2-1 2009 Medical electrical equipment - EN 60601-2-1 201X
Part 2-1: Particular requirements for the basic
safety and essential performance of electron
accelerators in the range 1 MeV to 50 MeV

IEC 60601-2-11 1997 Medical electrical equipment - EN 60601-2-11 1997
Part 2-11: Particular requirements for the
safety of gamma beam therapy equipment

IEC 60601-2-29 2008 Medical electrical equipment - EN 60601-2-29 2008
Part 2-29: Particular requirements for the + A11 2011
basic safety and essential performance of
radiotherapy simulators
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 62083 2009 Medical electrical equipment - Requirements EN 62083 2009
for the safety of radiotherapy treatment
planning systems
1)
To be published.
- 5 - EN 61217:2012
Annex ZZ
(informative)
Coverage of Essential 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 for 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 standard.
IEC 61217 ®
Edition 2.0 2011-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Radiotherapy equipment – Coordinates, movements and scales

Appareils utilisés en radiothérapie – Coordonnées, mouvements et échelles

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.50; 13.280 ISBN 978-2-88912-824-2

– 2 – 61217 © IEC:2011
CONTENTS
FOREWORD . 6
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 or 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") (Figures 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 Focus 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 Rotation 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 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
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 radial displacement from ISOCENTRE . 25

61217 © 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 systems . 57
Annex B (informative) Coordinate transformations between IEC and DICOM PATIENT
coordinates . 64
Bibliography .
...