SIST EN 60601-2-11:2015

SLOVENSKI STANDARD
SIST EN 60601-2-11:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-11:1998
SIST EN 60601-2-11:1998/A1:2005
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DJDPDUDGLRWHUDSLMR
Medical electrical equipment - Part 2-11: Particular requirements for basic safety and
essential performance of gamma beam therapy equipment
Medizinische elektrische Geräte - Teil 2-11: Besondere Festlegungen für die
Strahlensicherheit von Gamma-Bestrahlungseinrichtungen
Appareils électromédicaux - Part 2-11: Règles particulières de sécurité de base et de
performances essentielles pour les appareils de gammathérapie
Ta slovenski standard je istoveten z: EN 60601-2-11:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.60 Terapevtska oprema Therapy equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-11:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-11:2015

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SIST EN 60601-2-11:2015


EUROPEAN STANDARD EN 60601-2-11

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.60 Supersedes EN 60601-2-11:1997
English Version
Medical electrical equipment - Part 2-11: Particular requirements
for the basic safety and essential performance of gamma beam
therapy equipment
(IEC 60601-2-11:2013)
Appareils électromédicaux - Part 2-11: Exigences Medizinische elektrische Geräte - Teil 2-11: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Strahlensicherheit von Gamma-
essentielles des appareils de gammathérapie Bestrahlungseinrichtungen
(IEC 60601-2-11:2013) (IEC 60601-2-11:2013)
This European Standard was approved by CENELEC on 2015-04-14. 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, Former Yugoslav Republic of Macedonia, 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
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-11:2015 E

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SIST EN 60601-2-11:2015
EN 60601-2-11:2015
Foreword
The text of document 62C/552/FDIS, future edition 3 of IEC 60601-2-11, 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 EN 60601-2-11:2015.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-01-14
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-11:1997.
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 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-11:2013 was approved by CENELEC as a
European Standard without any modification.
2

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SIST EN 60601-2-11:2015
EN 60601-2-11:2015
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 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.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral Standard: Radiation protection in
diagnostic X-ray equipment
Addition to Annex ZA of EN 60601-1:2006:
IEC 61217 -  Radiotherapy equipment - Coordinates, EN 61217 -
movements and scales
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms

3

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SIST EN 60601-2-11:2015
EN 60601-2-11:2015
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 all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
4

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SIST EN 60601-2-11:2015



IEC 60601-2-11

®


Edition 3.0 2013-01




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical electrical equipment –

Part 2-11: Particular requirements for the basic safety and essential performance

of gamma beam therapy equipment




Appareils électromédicaux –

Partie 2-11: Exigences particulières pour la sécurité de base et les performances


essentielles des appareils de gammathérapie













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX X


ICS 11.040.60 ISBN 978-2-83220-584-6



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-11:2015
– 2 – 60601-2-11 © IEC:2013
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 . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents. 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 20
201.11 Protection against excessive temperatures and other HAZARDS . 38
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 39
201.13 HAZARDOUS SITUATIONS and fault conditions . 39
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTESM (PEMS) . 39
201.15 Construction of ME EQUIPMENT . 40
201.16 ME SYSTEMS . 40
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 40
Annexes . 45
Annex B (informative) Sequence of testing . 45
Index of defined terms used in this particular standard. 46

Figure 201.101 – Leakage radiation . 40
Figure 201.102 – Points for the measurement of average leakage . 42
Figure 201.103 – Test plane orthogonal to the RADIATION BEAM AXIS at the NORMAL
TREATMENT DISTANCE . 43
Figure 201.104 – Location of test points for SITE TEST of item 201.10.2.5.2.2 . 43
Figure 201.105 – Matrix measurement points for beam off and beam on conditions to
be specified at the floor level, ISOCENTER level and 1 m above the ISOCENTER level (see
requirement 201.10.2.4.2) . 44

Table 201.101 – Colours of TREATMENT CONTROL PANEL . 14
Table 201.102 – Subclauses in this particular standard requiring the provision of
information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and the technical
description . 14
Table 201.103 – Subclauses where data is described that is required in the technical
description to support Clause 201.10 site test compliance . 17

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SIST EN 60601-2-11:2015
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-11: Particular requirements for the basic safety
and essential performance of gamma beam therapy equipment

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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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 60601-2-11 has been prepared by 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 of IEC 60601-2-11 published in
1997 and its Amendment 1:2004. 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 standard is based on the following documents:
FDIS Report on voting
62C/552/FDIS 62C/558/RVD

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

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SIST EN 60601-2-11:2015
– 4 – 60601-2-11 © IEC:2013
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.
– 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 collateral 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.
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 stability 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.

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SIST EN 60601-2-11:2015
60601-2-11 © IEC:2013 – 5 –
INTRODUCTION
The use of GAMMA BEAM THERAPY EQUIPMENT for RADIOTHERAPY purposes may expose PATIENTS
to danger if the ME equipment fails to deliver the required dose to the PATIENT, or if the
ME equipment design does not satisfy standards of electrical and mechanical safety. The
ME EQUIPMENT may also cause danger to persons in the vicinity if the ME equipment itself fails
to contain the RADIATION adequately or if there are inadequacies in the design of the
TREATMENT ROOM.
This particular standard establishes requirements to be complied with by MANUFACTURERS in
the design and construction of gamma beam therapy equipment. Subclause 201.10.2 states
tolerance limits beyond which INTERLOCKS must prevent, INTERRUPT or TERMINATE IRRADIATION
in order to avoid an unsafe condition. TYPE TESTS which are performed by the MANUFACTURER,
or SITE TESTS, which are not necessarily performed by the MANUFACTURER, are specified for
each requirement.
Subclause 201.10.2 does not attempt to define the optimum performance requirements for a
GAMMA BEAM THERAPY EQUIPMENT for use in RADIOTHERAPY. Its purpose is to identify those
features of design which 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 at
which it can be presumed that a fault condition applies, e.g. a component failure, and where
an INTERLOCK then operates to prevent continued operation of the ME EQUIPMENT.
It should be understood that, before installation, a MANUFACTURER can provide a compliance
certificate relating only to TYPE TESTS. Data available from SITE TESTS should be incorporated
in the ACCOMPANYING DOCUMENTS, in the form of a SITE TEST report, by those who test the
ME EQUIPMENT after installation.
The relationship of this particular standard with IEC 60601-1 (including the amendments) and
the collateral standards is explained in 201.1.3 and 201.1.4.

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MEDICAL ELECTRICAL EQUIPMENT –

Part 2-11: Particular requirements for the basic safety
and essential performance of gamma beam therapy equipment



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 GAMMA
BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment,
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 GAMMA BEAM THERAPY EQUIPMENT.
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 201.2 of this particular standard.
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601-1 series apply as published.
_______________
1
 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

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SIST EN 60601-2-11:2015
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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
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 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 IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 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, figures or tables 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, figures or tables 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 clause or subclause in this particular standard, the 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:
Replacement:

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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 equipment
Addition:
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales
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 46.
Addition:
201.3.201
BEAM OFF
condition in which the RADIATION SOURCE(S) is(are) fully shielded, and are also in a position in
which they can be secured
201.3.202
BEAM ON
condition in which the RADIATION SOURCE(s) is(are) fully exposed for RADIOTHERAPY
201.3.203
CONTROLLING TIMER
TIMER
device to measure the time during which IRRADIATION occurs and, when a predetermined time
is reached, to TERMINATE IRRADIATION
201.3.204
GAMMA BEAM THERAPY EQUIPMENT
RADIONUCLIDE BEAM THERAPY EQUIPMENT, in which the RADIONUCLIDE is a gamma emitter
201.3.205
GANTRY
that part of the ME EQUIPMENT supporting and allowing possible movements of the RADIATION
HEAD
Note 1 to entry: MULTI-SOURCE STEREOTACTIC RADIOTHERAPY (MSSR) equipment usually is not equipped
with a gantry.
201.3.206
GEOMETRICAL FIELD SIZE
geometrical projection of the distal end of the BEAM LIMITING DEVICE on a plane orthogonal to
the RADIATION BEAM AXIS, as seen from the centre of the front surface of the RADIATION SOURCE
Note 1 to entry: The RADIATION FIELD is thus of the same shape as the aperture of the beam limiting device. The
geometrical field size may be defined at any distance from the RADIATION SOURCE.
201.3.207
HELMET
three dimensional multi-source ISOCENTRIC BEAM LIMITING SYSTEM used in MSSR for
TREATMENT VOLUMES within the head or neck

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201.3.208
INTERRUPTION OF IRRADIATION
INTERRUPTION
TO INTERRUPT IRRADIATION
TO INTERRUPT
stopping of/to stop IRRADIATION and movements with the possibility of continuing without
reselecting operating conditions
Note 1 to entry: I.e. a return to the READY STATE.
201.3.209
IRRADIATION FIELD SIZE
FIELD SIZE
dimensions of an area in a plane perpendicular to the radiation beam axis at a
specified distance from the RADIATION SOURCE or at a specified depth in the irradiated object
and defined by specified isodose lines
[SOURCE: IEC TR 60788:2004, rm-37-11]
201.3.210
MOVING BEAM RADIOTHERAPY
RADIOTHERAPY with any planned displacement of the RADIATION FIELD or PATIENT relative to
each other or with any planned change of ABSORBED DOSE distribution
[SOURCE: IEC TR 60788:2004, rm-42-41]
201.3.211
MULTI-SOURCE STEREOTACTIC RADIOTHERAPY
MSSR
RADIOTHERAPY using STEREOTACTIC RADIOTHERAPY procedure using more than one RADIATION
SOURCE
201.3.212
NORMAL TREATMENT DISTANCE
SPECIFIED distance measured along the RADIATION BEAM AXIS from the RADIATION SOURCE to the
ISOCENTRE or, for ME EQUIPMENT without an ISOCENTRE, to a SPECIFIED plane
201.3.213
PRIMARY/SECONDARY TIMER COMBINATION
PRIMARY/SECONDARY COMBINATION
combination of two TIMERS in which one is arranged to be the PRIMARY TIMER and the other is
to be the SECONDARY TIMER
201.3.214
PRIMARY TIMER
controlling timer which is intended to TERMINATE IRRADIATION at the pre-selected time
201.3.215
PROGRAMMABLE ELECTRONIC SUBSYSTEM
PESS
system based on one or more central processing units, including their software and interfaces
Note 1 to entry: These devices m
...