IEC 60601-2-11:2013

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

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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

– 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

60601-2-11 © IEC:2013 – 3 –
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
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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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
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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.

– 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.
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.

– 6 – 60601-2-11 © IEC:2013
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
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.
_______________
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

60601-2-11 © IEC:2013 – 7 –
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:
– 8 – 60601-2-11 © IEC:2013
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

60601-2-11 © IEC:2013 – 9 –
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 may contain one or more central processing units connected to sensors or
actuators, for the purpose of control, protection or monitoring.
[SOURCE: IEC 60601-1:2005, 3.91, modified – a note to entry has been added to the
definition.]
– 10 – 60601-2-11 © IEC:2013
201.3.216
QUALIFIED PERSON
person recognised by a competent authority as having the requisite knowledge and training to
perform specified duties
201.3.217
REDUNDANT TIMER COMBINATION
REDUNDANT COMBINATION
combination of two CONTROLLING TIMERS in which both are arranged to TERMINATE IRRADIATION
at the pre-selected time
201.3.218
RELATIVE SURFACE DOSE
ratio of the ABSORBED DOSE on its RADIATION BEAM AXIS at the depth of
0,5 mm to its maximum ABSORBED DOSE on its RADIATION BEAM AXIS, both measured in a
PHANTOM with its surface at a specified distance
ratio of the ABSORBED DOSE on each single RADIATION BEAM AXIS at the
depth of 0,5 mm to the maximum ABSORBED DOSE on the RADIATION BEAM AXIS, both measured
in a PHANTOM with its surface at a specified distance, when all other RADIATION SOURCES are
blocked
201.3.219
REPOSITIONING
movement and adjustment of the STEREOTACTIC frame with respect to the HELMET to alter the
intended TREATMENT VOLUME
201.3.220
REPOSITIONING POINT
retracted position of the HELMET where REPOSITIONING of the frame is possible
201.3.221
REPOSITIONING TIME
added time the ME EQUIPMENT needs to move from the BEAM ON condition to the REPOSITIONING
POINT, to achieve REPOSITIONING and to return from the REPOSITIONING POINT to the BEAM ON
condition
201.3.222
SECONDARY TIMER
CONTROLLING TIMER which is intended to TERMINATE IRRADIATION in the event of failure of the
PRIMARY TIMER
201.3.223
SITE TEST
test of the individual device or ME EQUIPMENT to establish compliance with specified criteria
after installation
201.3.224
STEREOTAXIS
STEREOTACTIC
method for locating points within the human body using an external, three-dimensional frame
of reference
60601-2-11 © IEC:2013 – 11 –
201.3.225
TERMINATION OF IRRADIATION
TERMINATION
TO TERMINATE IRRADIATION
TO TERMINATE
stopping of IRRADIATION with no possibility of re-starting without the re-selection of all
operating conditions
Note 1 to entry: This is the case when
– the pre-selected value of elapsed time is reached; or
– the IRRADIATION was terminated:
• by deliberate manual act;
• by the operation of an INTERLOCK;
• by pre-selected value of gantry angular position in MOVING BEAM RADIOTHERAPY.
201.3.226
TRANSITION TIME
time between when BEAM OFF condition is left until the BEAM ON condition is achieved or vice
versa
201.3.227
TRANSITION RADIATION
dose received during the TRANSITION TIME
201.3.228
TREATMENT
application of a prescribed procedure, or a part thereof, for therapeutic purposes
201.3.229
TREATMENT FIELD
area at the PATIENT'S surface which is to be IRRADIATED
201.3.230
TYPE TEST
test on a representative sample of the equipment with the objective of determining whether
the equipment, as designed and manufactured, can meet the requirements of this standard
[SOURCE: IEC 60601-1:2005, 3.135]
201.3.231
ZERO APPLICATOR
means to bypass the INTERLOCK in a system which includes an interlock against IRRADIATION
without a BEAM APPLICATOR
201.3.232
PASSWORD
sequence of keystrokes that permits OPERATOR access for NORMAL USE or to
reset INTERLOCKS and, with a different sequence of keystrokes, permits access for adjustment
and maintenance
201.4 General requirements
Clause 4 of the general standard applies.

– 12 – 60601-2-11 © IEC:2013
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.1 TYPE TESTS
Addition:
201.5.1.101 Test grades
TYPE
Test procedures described in this particular standard are classified into three grades of
TEST and two grades of SITE TEST. Their requirements are as follows:
YPE TEST grade A: an analysis of ME EQUIPMENT design, as related to the SPECIFIED
– T
RADIATION safety provisions, and inspection of the RISK MANAGEMENT FILE, which shall
result in a statement included in the technical description, regarding the working principles
or constructional means by which the requirement is fulfilled.
YPE TEST/SITE TEST grade B: visual inspection or functional test or measurement of the
– T
ME EQUIPMENT. The test shall be carried out in accordance with the procedure SPECIFIED In
this particular standard and shall be based on operating states, including fault condition
states, which are achievable only without interference with the circuitry or construction of
the ME EQUIPMENT.
– TYPE TEST/SITE TEST grade C: functional test or measurement of the ME EQUIPMENT. The
test shall be in accordance with the principle SPECIFIED in this particular standard. The SITE
TEST procedure shall be included in the technical description. When the procedure
involves operating states that require interference with circuitry or the construction of the
ME EQUIPMENT, the test should be performed by, or under the direct supervision of, the
or his agent.
MANUFACTURER
NOTE 1 The division between TYPE TEST and SITE TEST enables the testing of the entire functionality including
aspects of the final assembly and installation of the individual EQUIPMENT with and without radioactive sources
loaded .
NOTE 2 The distinction between grade B and grade C tests is that this standard specifies the PROCEDURES for
grade B tests whereas, for grade C tests, the PROCEDURES need to be decided by the MANUFACTURER according to
the design of the particular ME EQUIPMENT, and this standard specifies only the principles.
NOTE 3 It may be beneficial to perform TYPE TEST grade A during the design of the EQUIPMENT.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 Protection against electric shock
Replacement:
ME EQUIPMENT within the scope of this standard shall be CLASS I.
ME EQUIPMENT within the scope of this standard shall have TYPE B APPLIED PART or TYPE BF
APPLIED PART.
NOTE Generally ME EQUIPMENT other than MSSR will have TYPE B APPLIED PARTS but TYPE BF APPLIED PARTS are
not prohibited.
201.6.3 Protection against harmful ingress of water or particulate matter
Replacement:
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Unless otherwise SPECIFIED, ME EQUIPMENT within the scope of this standard shall be ordinary
ME EQUIPMENT (enclosed ME EQUIPMENT without protection against ingress of water).
201.6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT
Replacement:
ME EQUIPMENT within the scope of this standard is not suitable for use in the presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies except as follows:
201.7.2.13 Physiological effects (safety signs and warning statements)
Addition:
The RADIATION HEAD shall be clearly and permanently marked on its outer surface with a
RADIATION warning sign according to IEC TR 60878.
SITE TEST – Grade B – Procedure: visually inspect the RADIATION HEAD.
201.7.2.20 Removable protective means
Addition:
Where the requirements of this item are wholly or partly met by the nature of the installation,
compliance at installation should be checked by inspection in order to prove that all parts are
delivered and installed correctly. The results should be included in the SITE TEST report.
201.7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.3.101 RADIATION HEAD
RADIATION HEAD shall expose symbol 10 of Table D.2 of the
Removal of the covers of the
general standard, “Follow operating instructions”.
Subassemblies that are exposed with the removal of covers and containing radioactive
sources should be marked with RADIATION warning signs according to IEC TR 60878.
201.7.4 Marking of controls and instruments
Additional subclause:
201.7.4.101 Therapy equipment
The following shall be provided:
a) a mechanical scale or a numerical indication for each available movement. This does not
apply in the case of MSSR during the set-up of the PATIENT.
NOTE For MSSR, during set-up of the PATIENT, the PATIENT SUPPORT is not in the position it will be in during
TREATMENT.
b) when applicable, a LIGHT FIELD, with an indication of the position of the REFERENCE AXIS.
This item is not applicable for MSSR;

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c) a scale or numerical indication of the distance along the REFERENCE AXIS from the front
surface of the RADIATION SOURCE to the surface of the PATIENT (RADIATION SOURCE TO SKIN
DISTANCE). This item is not applicable for MSSR.
The designation, direction of increasing value and zero position of all movements shall comply
with IEC 61217. For MSSR: IEC 61217 shall be used where applicable.
Compliance is checked by inspection.
201.7.8 Indicator lights and controls
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 accord with the requirements in Table 201.101.
Table 201.101 – Colours of TREATMENT CONTROL PANEL
Colour Meaning
Red Urgent action required in response to an unintended state of operation, e.g. if any
TRANSITION TIME or MSSR REPOSITIONING TIME exceeds the specified limits
a
Yellow RADIATION BEAM ON
Yellow flashing SHUTTER or SOURCE CARRIER in an intermediate position. Also for MSSR transition and
repositioning states
a
Green READY STATE
Green BEAM OFF
Any other colour PREPARATORY STATE
a
In the TREATMENT ROOM or at other locations, these states may require urgent action or caution; different
colours, in accordance with Table 2 of the general standard, may therefore be used in such locations.

Visual displays indicating the “meaning” described in Table 201.101 shall adhere to the same
colour scheme. The indicator lights should support the interpretation by colour-blind people.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
Table 201.102 – Subclauses in this particular standard requiring
the provision of information in the ACCOMPANYING DOCUMENTS,
INSTRUCTIONS FOR USE and the technical description
Check reference ACCOMPANYING INSTRUCTIONS FOR USE Technical description
a
DOCUMENTS
1  201.5.1.101
2 201.7.3.101
3 201.7.9
4 201.7.9.2
5 201.7.9.2.1
6 201.7.9.2.9
7  201.7.9.3
8 201.8.8.3
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Check reference ACCOMPANYING INSTRUCTIONS FOR USE Technical description
a
DOCUMENTS
9 201.9.2.2.5 b)
10 201.9.8.101 b)
11 201.10.2.2.2.2
12 201.10.2.2.2.3 b) c) d)
13 201.10.2.2.4.3 d) h) i)
14 201.10.2.2.4.4 d)
15 201.10.2.2.4.5 c)
16 201.10.2.3
17 201.10.2.4.1.2
18 201.10.2.4.2
19 201.10.2.5.4.1
20 201.10.2.5.4.3
21 201.10.2.5.4.4
22 201.10.2.5.5
23 201.14.101 e)
NOTE The numbers in the first column are short references for convenience when checking whether the
information required by each subclause is present.
a The information listed in this column may be in either the INSTRUCTIONS FOR USE or the Technical description
or somewhere else in the ACCOMPANYING DOCUMENTS.

201.7.9.2 INSTRUCTION FOR USE
201.7.9.2.1 General
Addition:
INSTRUCTIONS FOR USE shall state the recommended inspection or replacement intervals for
any parts having a safety function which are subject to impairment caused, during the NORMAL
USE of the ME EQUIPMENT, by the effects of IONISING RADIATION on the dielectric or mechanical
strength of those parts.
If, in order to function safely and correctly, the GAMMA BEAM THERAPY EQUIPMENT or a sub-
assembly thereof needs to dissipate heat at a certain rate, the cooling requirements shall be
given in the INSTRUCTIONS FOR USE, including, as appropriate:
– the maximum rate of heat to be dissipated into the surrounding air for each sub-assembly
which dissipates more than 100 W and which might be located separately on installation;
– flow rates and temperature rises in forced-air cooling systems at the stated maximum
rates of heat dissipation;
– the maximum allowable input temperatures, the minimum allowable flow rates and input
pressures, for the maximum rates of heat dissipation into any cooling medium other than
air;
– other essential requirements, e.g. maximum permissible temperatures at specified places.
201.7.9.2.9 Operating Instructions
Addition:
INSTRUCTIONS FOR USE shall contain:

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a) a list of all INTERLOCKS and other RADIATION safety devices, and explanation of their
function;
b) instructions for checking the operation of these devices;
c) a recommendation of the frequency with which such checks should be made;
d) dimensional drawings necessary for the use of the ME EQUIPMENT;
NOTE 1 For instance, due to the use of accessories.
e) instructions for the procedure to put the ME EQUIPMENT into the BEAM OFF condition in an
emergency (see 201.10.2.2.2.3);
NOTE 2 The instructions for use are used to practice emergency routines
f) the numerical value of the TRANSITION TIMES from the BEAM OFF to BEAM ON condition and
the BEAM ON to BEAM OFF condition and the proportion of the TRANSITION TIME for which the
RADIATION SOURCE is exposed (see 201.10.2.2.4.3);
g) a description of the functioning of the PRIMARY TIMER. In the case of a REDUNDANT TIMER
COMBINATION the functioning of both TIMERS shall be given (see 201.10.2.2.4.3);
h) a description of the functioning of the SECONDARY TIMER if it may be caused to TERMINATE
IRRADIATION in special therapy techniques (see 201.10.2.2.4.5);
i) a description of the levels of the RELATIVE SURFACE DOSE on the RADIATION BEAM AXIS for
any ACCESSORY provided by the MANUFACTURER if those levels exceed the values specified
in 201.10.2.3;
j) a description of the circumstances and the levels to be expected if, for non-square fields,
the levels specified in 201.10.2.4 are exceeded. This item is not applicable for MSSR;
k) a description of the parts of the ME EQUIPMENT ENCLOSURE where the ABSORBED DOSE due
to LEAKAGE RADIATION exceeds the levels specified in 201.10.2.4.2 b) and a statement of
the level to be expected;
l) instructions for emergency procedures to be adopted after failure of the SHUTTER or
SOURCE CARRIER actuating means (see 201.10.2.5.4.1);
m) a statement of the dimensions of the RADIATION SOURCE cavity and the outer dimensions of
the RADIATION SOURCE for which the ME EQUIPMENT can be used;
n) a statement of the positions on the RADIATION HEAD where wipe tests are recommended to
be performed and the results of such tests undertaken by the MANUFACTURER (see
201.10.2.5.4.4.), and
o) information on radioactive material used in the construction of the ME EQUIPMENT as
required in 201.10.2.5.
201.7.9.3 Technical description
201.7.9.3.1 General
Addition:
To assist the RESPONSIBLE ORGANIZATION'S RADIOLOGICAL PROTECTION adviser, the following
data shall be provided:
a) The RADIONUCLIDE(S) for which that particular ME EQUIPMENT is designed.
b) The maximum RADIATION SOURCE ACTIVITY for each RADIONUCLIDE for which the
ME EQUIPMENT is capable of meeting the requirements of this standard. The maximum
RADIATION SOURCE ACTIVITY may depend on the source geometry and construction.
c) The maximum ABSORBED DOSE RATE for the maximum cross-section of the RADIATION BEAM
at a distance of 1 m from the RADIATION SOURCE for each RADIONUCLIDE for which the
requirements of this standard are met. In case of MSSR the maximum ABSORBED DOSE
RATE for the maximum cross-section of the RADIATION BEAM at the ISOCENTRE or at the
centre of the common volume defined by all the RADIATION BEAMS for each RADIONUCLIDE
for which the requirements of this standard are met.

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d) The location, with reference to an accessible point on the RADIATION HEAD, of the centre of
the front surface of the RADIATION SOURCE in both the BEAM ON and BEAM OFF conditions.
This item is not applicable for MSSR.
e) The NORMAL TREATMENT DISTANCE and maximum GEOMETRICAL FIELD SIZE available at the
NORMAL TREATMENT DISTANCE.
f) The available directions of the RADIATION BEAM.
g) The TRANSITION TIMES from the BEAM OFF to BEAM ON condition and from the BEAM ON to
BEAM OFF condition and the proportion of the TRANSITION TIMES for which the RADIATION
SOURCE is EXPOSED.
h) Matrix measurement points for radiation levels for BEAM ON and BEAM OFF conditions at the
floor level and at 0,5 m, 1,0 m, 1,5 m and 2 m above the floor level in MSSR (see Figure
201.105).
Table 201.103 –Subclauses where data is described that is required
in the technical description to support Clause 201.10 site test compliance

Compliance Statement Details of, Details of, SPECIFIC SPECIFIC
subclause regarding data and results and results procedures and procedures an
...