SIST EN 60601-2-29:2009

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008)

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
RADIOTHERAPY SIMULATORS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

Medizinische elektrische Geräte - Teil 2-29: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Strahlentherapiesimulatoren (IEC 60601-2-29:2008)

Appareils électromédicaux - Partie 2-29: Exigences particulières pour la sécurité de base et performances essentielles des simulateurs de radiothérapie (CEI 60601-2-29:2008)

La CEI 60601-2-29:2008 décrit les exigences auxquelles les fabricants doivent se conformer lors de la conception et de la construction des simulateurs de radiothérapie; elle ne vise pas à définir des exigences de performances optimales. Son objet est d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils électromédicaux. Elle fixe des limites de détérioration des performances des appareils électromédicaux qui seraient la conséquence d'une condition de défaut, telle que la défaillance d'un  composant, pour lesquelles un verrouillage doit entrer en action pour empêcher l'appareil électromédical de continuer à fonctionner. Cette troisième édition annule et remplace la deuxième édition parue en 1999, dont elle constitue une révision technique, qui représente un alignement de cette norme avec la troisième édition de la CEI 60601-1 et ses normes collatérales.

Medicinska električna oprema - 2-29. del: Posebne zahteve za osnovno varnost in bistvene lastnosti radioterapevtskih simulatorjev (IEC 60601-2-29:2008)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI RADIOTERAPEVTSKIH SIMULATORJEV, v nadaljevanju ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

• Status: Published
• Publication Date: 11-Dec-2008
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Dec-2008
• Due Date: 09-Feb-2009
• Completion Date: 12-Dec-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-29:2008 - Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

Relations

• Amended By: SIST EN 60601-2-29:2009/A11:2012 - Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
• Effective Date: 28-Jan-2023
• Replaces: SIST EN 60851-3:2001/A2:2004 - Winding wires - Test methods -- Part 3: Mechanical properties
• Effective Date: 27-Jan-2023
• Replaces: SIST EN 60601-2-29:2002 - Medical electrical equipment -- Part 2-29: Particular requirements for the safety of radiotherapy simulators
• Effective Date: 29-Jan-2023
• Amended By: SIST EN 60601-2-29:2009/A11:2012 - Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
• Effective Date: 11-Oct-2011
• Revised: SIST EN 60601-2-29:2002 - Medical electrical equipment -- Part 2-29: Particular requirements for the safety of radiotherapy simulators
• Effective Date: 08-Nov-2011
• Replaces: SIST EN 60601-2-29:2002 - Medical electrical equipment -- Part 2-29: Particular requirements for the safety of radiotherapy simulators
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-29:2009
01-februar-2009
1DGRPHãþD
SIST EN 60601-2-29:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUDGLRWHUDSHYWVNLKVLPXODWRUMHY,(&
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and
essential performance of radiotherapy simulators (IEC 60601-2-29:2008)
Medizinische elektrische Geräte - Teil 2-29: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Strahlentherapiesimulatoren
(IEC 60601-2-29:2008)
Appareils électromédicaux - Partie 2-29: Exigences particulières pour la sécurité de base
et performances essentielles des simulateurs de radiothérapie (CEI 60601-2-29:2008)
Ta slovenski standard je istoveten z: EN 60601-2-29:2008
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-29:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-2-29:2009

---------------------- Page: 2 ----------------------

SIST EN 60601-2-29:2009

EUROPEAN STANDARD
EN 60601-2-29

NORME EUROPÉENNE
November 2008
EUROPÄISCHE NORM

ICS 11.040.60 Supersedes EN 60601-2-29:1999


English version


Medical electrical equipment -
Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators
(IEC 60601-2-29:2008)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-29: Exigences particulières Teil 2-29: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des simulateurs de radiothérapie von Strahlentherapiesimulatoren
(CEI 60601-2-29:2008) (IEC 60601-2-29:2008)




This European Standard was approved by CENELEC on 2008-11-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, 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 and the United Kingdom.

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

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-29:2008 E

---------------------- Page: 3 ----------------------

SIST EN 60601-2-29:2009
EN 60601-2-29:2008 - 2 -
Foreword
The text of document 62C/423/CDV, future edition 3 of IEC 60601-2-29, 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 Unique Acceptance Procedure and was approved
by CENELEC as EN 60601-2-29 on 2008-11-01.
This European Standard supersedes EN 60601-2-29:1999.
EN 60601-2-29:2008 constitutes a technical revision, which brings EN 60601-2-29 in line with
EN 60601-1:2006 and its collateral standards.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2009-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2011-11-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
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 DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
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.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
Annexes ZA and ZZ have been added by CENELEC.
__________

---------------------- Page: 4 ----------------------

SIST EN 60601-2-29:2009
- 3 - EN 60601-2-29:2008
Endorsement notice
The text of the International Standard IEC 60601-2-29:2008 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 60601-1-3 NOTE  Harmonized as EN 60601-1-3:2008 (not modified).
IEC 60601-1-8 NOTE  Harmonized as EN 60601-1-8:2007 (not modified).
IEC 60601-2-1 NOTE  Harmonized as EN 60601-2-1:1998 (not modified).
__________

---------------------- Page: 5 ----------------------

SIST EN 60601-2-29:2009
EN 60601-2-29:2008 - 4 -
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

Addition to Annex ZA of EN 60601-1:2006:
Publication Year Title EN/HD Year

IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms


1) 2)
IEC 61217 - Radiotherapy equipment - EN 61217 1996
Coordinates, movements and scales


1)
Undated reference.
2)
Valid edition at date of issue.

---------------------- Page: 6 ----------------------

SIST EN 60601-2-29:2009
- 5 - EN 60601-2-29:2008
Annex ZZ
(informative)

Coverage of Essential Requirements of EC 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 all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
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.

---------------------- Page: 7 ----------------------

SIST EN 60601-2-29:2009

---------------------- Page: 8 ----------------------

SIST EN 60601-2-29:2009
IEC 60601-2-29
Edition 3.0 2008-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-29: Particular requirements for the basic safety and essential performance
of radiotherapy simulators

Appareils électromédicaux –
Partie 2-29: Exigences particulières pour la sécurité de base et les performances
essentielles des simulateurs de radiothérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
T
CODE PRIX
ICS 11.040.60 ISBN 2-8318-9854-4

---------------------- Page: 9 ----------------------

SIST EN 60601-2-29:2009
– 2 – 60601-2-29 © IEC:2008
CONTENTS
FOREWORD.3
INTRODUCTION.5

201.1 Scope, object and related standards .6
201.2 Normative references.7
201.3 Terms and definitions.8
201.4 General requirements.8
201.5 General requirements for testing of ME EQUIPMENT.8
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .8
201.7 ME EQUIPMENT identification, marking and documents.9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.11
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS .11
201.10 Protection against unwanted and excessive radiation HAZARDS.18
201.11 Protection against excessive temperatures and other HAZARDS.18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.19
201.13 HAZARDOUS SITUATIONS and fault conditions.19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19
201.15 Construction of ME EQUIPMENT .19
201.16 ME SYSTEMS .19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .19
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.20
Annex AA (informative) Particular guidance and rationale.21
Bibliography.22
Index of defined terms used in this particular standard.23

Figure 101 – Equipment movements and scales – Rotary GANTRY with identification of
axes 1 to 8, directions 9 to 13, and dimensions 14 and 15 (see accompanying table) .14
Figure 102 – Equipment movements and scales – ISOCENTRIC RADIOTHERAPY SIMULATOR
or TELERADIOTHERAPY ME EQUIPMENT, with identification of axes 1; 4 to 6; 19, of
15
directions 9 to 12; 16 to 18 and of dimensions 14; 15 (see accompanying table).
Figure 103 – Equipment movements and scales – View from RADIATION SOURCE of
TELERADIOTHERAPY RADIATION FIELD or RADIOTHERAPY SIMULATOR DELINEATED RADIATION
FIELD (see accompanying table) .16

Table 201.101 – Description of equipment movements .17
Table 201.C.101 – ACCOMPANYING DOCUMENTS, General .20
Table 201.C.102 – ACCOMPANYING DOCUMENTS, Instructions for use .20
Table 201.C.103 – ACCOMPANYING DOCUMENTS, technical description.20

---------------------- Page: 10 ----------------------

SIST EN 60601-2-29:2009
60601-2-29 © IEC:2008 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators


FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-29 has been prepared by IEC subcommittee 62C:
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical
committee 62: Electrical equipment in medical practice.
This third edition cancels and replaces the second edition published in 1999. This edition
constitutes a technical revision, which brings this standard in line with the third edition of
IEC 60601-1 and its collateral standards.
The text of this particular standard is based on the following documents:
CDV Report on voting
62C/423/CDV 62C/434/RVC

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

---------------------- Page: 11 ----------------------

SIST EN 60601-2-29:2009
– 4 – 60601-2-29 © IEC:2008
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
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.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
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.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex A.
A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

---------------------- Page: 12 ----------------------

SIST EN 60601-2-29:2009
60601-2-29 © IEC:2008 – 5 –
INTRODUCTION
This particular standard establishes requirements to be complied with by MANUFACTURERS in
the design and construction of RADIOTHERAPY SIMULATORS; it does not attempt to define their
optimum performance requirements. Its purpose is to identify those features of design that are
regarded, at the present time, as essential for the safe operation of such ME EQUIPMENT. It
places limits on the degradation of ME EQUIPMENT performance beyond which it can be
presumed that a fault condition exists, for example a component failure, and where an
INTERLOCK then operates to prevent continued operation of the ME EQUIPMENT.

---------------------- Page: 13 ----------------------

SIST EN 60601-2-29:2009
– 6 – 60601-2-29 © IEC:2008
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators



201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
RADIOTHERAPY SIMULATORS, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for RADIOTHERAPY SIMULATORS [as defined in 201.3.204].
201.1.3 *Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 2 of this particular standard.
The following collateral standard does not apply:
– IEC 60601-1-10.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
—————————
1)
 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance

---------------------- Page: 14 ----------------------

SIST EN 60601-2-29:2009
60601-2-29 © IEC:2008 – 7 –
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of sections, clauses and subclauses of this particular standard corresponds to
that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the
content of Clause 1 of the general standard) or applicable collateral standard with the prefix
“20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in
this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3
collateral standard, etc.). The changes to the text of the general standard are specified by the
use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of the general standard are numbered
starting from 201.101. However due to the fact that definitions in the general standard are
numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning
from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Subclauses or figures which are additional to those of a collateral standard are numbered
starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-
1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the
section, clause or subclause of the general standard or applicable collateral standard,
although possibly not relevant, applies without modification; where it is intended that any part
of the general standard or applicable collateral standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Addition:
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales

---------------------- Page: 15 ----------------------

SIST EN 60601-2-29:2009
– 8 – 60601-2-29 © IEC:2008
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC TR 60788:2004 apply, except as follows:
NOTE An index of defined terms is found beginning on page 23.
Addition:
201.3.201
DELINEATED RADIATION BEAM
that part of the RADIATION BEAM bordered by the shadow cast by the DELINEATORS
201.3.202
DELINEATED RADIATION FIELD
area of the DELINEATED RADIATION BEAM intercepted on a plane perpendicular to the REFERENCE
AXIS
201.3.203
DELINEATOR(S)
means for defining the border(s) of the simulated radiation field
201.3.204
RADIOTHERAPY SIMULATOR
SIMULATOR
ME EQUIPMENT that uses X-RAY EQUIPMENT to simulate geometrically the parameters of
movements and RADIATION FIELDS of RADIOTHERAPY ME EQUIPMENT to assist with the planning of
PATIENT treatments
NOTE This definition does not include:
− CT-simulation devices and MR-simulation devices;
− virtual simulation computer programs;
− imaging modalities that form a part of gamma beam therapy equipment or of electron accelerators.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
Addition:
– a sufficiently low internal impedance to prevent voltage fluctuations exceeding ±5 %
between the on-load and off-load steady states.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.

---------------------- Page: 16 ----------------------

SIST EN 60601-2-29:2009
60601-2-29 © IEC:2008 – 9 –
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.4 Marking of controls and instruments
Additional subclause:
201.7.4.101 Provision of scales and indications for moving parts
a) The following shall be provided:
– a numerical indication of the dimensions of the DELINEATED RADIATION FIELD at a
SPECIFIED distance;
– a visual indication of the RADIATION BEAM and the DELINEATED RADIATION FIELD;
– an indication of the position of the ISOCENTRE;
– means for indicating the FOCAL SPOT TO SKIN DISTANCE;
– an indication of the position of the REFERENCE AXIS on entry to the PATIENT or X-RAY
IMAGE RECEPTOR;
– an indication to the OPERATOR, associated with the angular position of the DELINEATED
RADIATION BEAM, of the possible WEDGE FILTER direction(s) for the RADIOTHERAPY ME
EQUIPMENT being simulated;
– a numerical indication of the distance from the FOCAL SPOT to the IMAGE RECEPTOR
PLANE;
– a numerical indication of the distance from the ISOCENTRE to the FOCAL SPOT when this
parameter is adjustable;
– scale readouts complying with the conventions of IEC 61217, for all available
movements of GANTRY, RADIATION HEAD and BLSs (BEAM LIMITING SYSTEMS),
DELINEATORS, X-RAY IMAGE RECEPTOR and PATIENT SUPPORT.
b) In order to reduce the possibility of error when transferring data between SIMULATORS and
RADIOTHERAPY ME EQUIPMENT having other scale conventions, SIMULATORS may incorporate
additional scale readouts supporting other scale conventions, in which case the scale
convention then being DISPLAYED by the SIMULATOR shall be unambiguous.
Compliance is checked by inspection.
201.7.8.1 Colours of indicator lights
Addition:
Where indicator lights are used on the TREATMENT CONTROL PANEL (TCP), or other CONTROL
PANELS, the colours of the lights shall be in accordance with the following:
– RADIATION BEAM “on” yellow;
– READY STATE green;
– urgent action required in response to an unintended state of
operation red;
– PREPARATORY STATE other colour.
NOTE In the SIMULATOR room, or in other locations, the states “RADIATION BEAM on” and “READY STATE” may need
urgent action or caution; different colours, in accordance with Table 2 of the general standard, may therefore be
used in such locations.
Light emitting diodes (LEDs) are not considered to be indicator lights when:
CONTROL PANEL, all indications for which no particular colour is required are given
– on any
...