IEC 60601-2-17:2013

IEC 60601-2-17 ®
Edition 3.0 2013-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-17: Particular requirements for the basic safety and essential performance
of automatically-controlled brachytherapy afterloading equipment

Appareils électromédicaux –
Partie 2-17: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils projecteurs de sources radioactives à chargement
différé automatique utilisés en brachythérapie

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IEC 60601-2-17 ®
Edition 3.0 2013-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-17: Particular requirements for the basic safety and essential

performance of automatically-controlled brachytherapy afterloading equipment

Appareils électromédicaux –
Partie 2-17: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils projecteurs de sources radioactives à

chargement différé automatique utilisés en brachythérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.60 ISBN 978-2-8322-1214-1

– 2 – 60601-2-17  IEC:2013
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing 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 . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 37
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 37
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 40
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 40
201.15 Construction of ME EQUIPMENT . 40
201.16 ME SYSTEMS . 40
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 40
Annex A (informative) General guidance and rationale . 41
Bibliography . 42
Index of defined terms used in this particular standard . 43

Table 201.101 – Colours of lights and their meanings . 14

60601-2-17  IEC:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy
afterloading 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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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 60601-2-17 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 2004. Consideration
has been given to new IEC standards, amendments to existing IEC standards, developments
in technology and clinical usage, and various hazards encountered and envisaged since the
preparation of the first and second editions. This edition constitutes a technical revision which
brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.

– 4 – 60601-2-17  IEC:2013
The text of this particular standard is based on the following documents:
FDIS Report on voting
62C/575/FDIS 62C/579/RVD
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.
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 201.7 includes subclauses 201.7.1, 201.7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and
201.7.2.1 are all subclauses of Clause 201.7).
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.

60601-2-17  IEC:2013 – 5 –
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.
– 6 – 60601-2-17  IEC:2013
INTRODUCTION
The delivery of RADIOTHERAPY over short distances is called BRACHYTHERAPY. BRACHYTHERAPY
is delivered by positioning RADIATION SOURCES within or adjacent to the tissue to be treated.
Historically, RADIOACTIVE SOURCES were handled manually, resulting in IRRADIATION of the
OPERATOR’S hands. AFTERLOADING generally refers to the technique of placing an applicator
into or adjacent to the tissue to be treated, and introducing one or more RADIATION SOURCE(S)
only after the applicator position has been confirmed. This procedure minimizes the time
during which the operator is exposed to the RADIATION SOURCE(S). Manual AFTERLOADING
techniques were developed in the 1950s and are used routinely today for permanent implants,
but less frequently for temporary implants.
Temporary implants require the use of higher dose rates, to ensure that the treatment can be
completed in a length of time easily tolerated by the PATIENT. In the 1980s, automatic remote
AFTERLOADING techniques were developed, that could move a RADIOACTIVE SOURCE or SOURCES
through connecting tubes from a shielded safe to the applicators implanted in the patient.
Because the SOURCE(S) could be moved remotely, the risk of exposure to personnel could be
eliminated.
In 2007 an automatic remote afterloader was introduced that replaced the conventional
RADIOACTIVE SOURCE(S) with an X-ray source. This device otherwise performed similarly to
AFTERLOADERS containing RADIOACTIVE SOURCES. However, the X-ray source could be disabled
when not in use, removing any risk of IRRADIATION. BRACHYTHERAPY devices that employ X-ray
source(s) are subject to the requirements of IEC 60601-2-8, in addition to those of this
standard.
The use of AFTERLOADING ME EQUIPMENT for BRACHYTHERAPY 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 RADIOACTIVE SOURCE(S) adequately within the STORAGE CONTAINER(S), if the X-RAY
TUBE is energized inappropriately, 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 AFTERLOADING ME EQUIPMENT for use in temporary
BRACHYTHERAPY procedures; 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 and at which an INTERLOCK then operates to disable the X-RAY TUBE(S) or
return the RADIOACTIVE SOURCE(S) to the STORAGE CONTAINER(S) and afterwards to prevent
continued operation of the ME EQUIPMENT.

60601-2-17  IEC:2013 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy
afterloading 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
automatically-controlled BRACHYTHERAPY AFTERLOADING ME 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.
This standard applies to automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT
used for treatment or alleviation of disease.
This standard specifies requirements
a) for automatically-controlled AFTERLOADING ME EQUIPMENT
1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE
SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with
automatically-controlled AFTERLOADING ME EQUIPMENT,
2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in
the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT,
to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION
SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the
reference location,
3) which is designed for connection to a PATIENT, and
4) with which movements of the RADIATION SOURCE(S) are carried out automatically by
the ME EQUIPMENT according to a prescribed programme using a powered mechanism
whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that
are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or
microprocessors) or non-programmable systems and
b) for ME EQUIPMENT intended to be
—————————
The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance

– 8 – 60601-2-17  IEC:2013
1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED
PERSONS by OPERATORS having the required skills for a particular medical application,
for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY;
2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR
USE;
3) subject to regular quality assurance performance and calibration checks by a
QUALIFIED PERSON.
This standard does not specify requirements for SEALED RADIOACTIVE SOURCES. Requirements
for the design of X-RAY TUBES used with the ME EQUIPMENT are specified in other IEC
standards. See for example: IEC 60601-2-28:2010.
The requirements of this standard are based on the assumptions that:
– a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT
PARAMETERS, and
– the SOURCE STRENGTH(S) or the REFERENCE AIR-KERMA RATE of the RADIATION SOURCE(S)
used by the ME EQUIPMENT is (are) known.
This standard includes requirements intended to ensure that the prescribed values of the
TREATMENT PARAMETERS can be achieved by the ME EQUIPMENT, in particular that:
– the selected RADIATION SOURCE(S) is (are) positioned or moved within the SOURCE
APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
– IRRADIATION is performed by the selected RADIATION SOURCE configuration for the selected
duration;
– IRRADIATION is performed by the ME EQUIPMENT without causing unnecessary RISK to the
OPERATOR or other persons in the immediate surroundings.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for automatically-controlled BRACHYTHERAPY AFTERLOADING
ME 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 standard.
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601 series apply as published.
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.
—————————
IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

60601-2-17  IEC:2013 – 9 –
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005+A1:2012, 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
NOTE Informative references are listed in the bibliography on page 42.
Clause 2 of the general standard applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
—————————
A consolidated edition 3.1 exists, including IEC 60601-1:2005 and its Amendment 1:2012.

– 10 – 60601-2-17  IEC:2013
IEC 60601-2-1:2009, Medical electrical equipment – Part 2-1: Particular requirements for the
basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-8:2010, Medical electrical equipment – Part 2-8: Particular requirements for the
basic safety and essential performance of therapeutic X-ray equipment operating in the range
10 kV to 1 MV
IEC 60601-2-11:2013, Medical electrical equipment - Part 2-11: Particular requirements for
the basic safety and essential performance of gamma beam therapy equipment
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61005:2003, Radiation protection instrumentation – Neutron ambient dose equivalent
(rate) meters
IEC 62083:2009, Medical electrical equipment – Requirements for the safety of radiotherapy
treatment planning systems
201.3 Terms and definitions
For the purposes of this particular standard, the terms and definitions given in
IEC 60601-1:2005+A1:2012 and IEC/TR 60788:2004 apply, except as follows:
NOTE 1 An index of defined terms is found beginning on page 43.
NOTE 2 In this particular standard, IRRADIATION refers to the entire process of exposing the PATIENT to RADIATION
SOURCES in positions and for periods of time appropriate for TREATMENT. TRANSIT times are explicitly excluded from
the TREATMENT TIME.
Addition:
201.3.201
AFTERLOADING
automatically-controlled transfer of one or more SEALED RADIOACTIVE SOURCES or X-ray
sources between a STORAGE CONTAINER or, in the case of X-ray sources, a reference position,
and pre-positioned SOURCE APPLICATORS for BRACHYTHERAPY
201.3.202
ALARM SIGNAL
signal, the purpose of which is to alert the OPERATOR to an abnormal condition in the PATIENT
or the equipment that may develop into a safety HAZARD which requires OPERATOR awareness
or action
201.3.203
BETA SOURCE STRENGTH
ABSORBED DOSE RATE in water at 2 mm along the perpendicular bisector from a RADIATION
SOURCE emitting beta RADIATION
-1
Note 1 to entry: The unit of beta source strength is Gy s at 2 mm.
Note 2 to entry: Multiples (milli, mega, etc.) are permitted.
201.3.204
BRACHYTHERAPY
RADIOTHERAPY using one or more RADIATION SOURCES with the RADIATION SOURCE/SOURCES
inside or close to the TARGET VOLUME
Note 1 to entry: Brachytherapy techniques include interstitial, intracavitary, superficial or intraluminal
radiotherapy.
60601-2-17  IEC:2013 – 11 –
201.3.205
CONTINUATION OF IRRADIATION
CONTINUATION
re-starting IRRADIATION after INTERRUPTION OF IRRADIATION without re-selection
of operating conditions
201.3.206
DWELL TIME
time a RADIATION SOURCE or a RADIATION SOURCE TRAIN remains at a selected TREATMENT
position or the time the BRACHYTHERAPY X-RAY SOURCE remains activated at a selected
TREATMENT position
201.3.207
INITIATION OF IRRADIATION
INITIATION
commencing IRRADIATION from the READY STATE when the READY STATE was attained by
carrying out the selection and confirmation of the operating conditions and not by
INTERRUPTION OF IRRADIATION
201.3.208
NEUTRON SOURCE STRENGTH
ABSORBED DOSE RATE IN WATER of a RADIATION source emitting NEUTRONS
-1
Note 1 to entry: The unit of NEUTRON SOURCE STRENGTH is, for the purposes of this standard, Gy s at 1 cm.
Note 2 to entry: Multiples (milli, mega, etc.) are permitted.
201.3.209
PHOTON SOURCE STRENGTH
REFERENCE AIR KERMA RATE along the perpendicular bisector from a RADIATION SOURCE emitting
PHOTONS
-1
Note 1 to entry: The unit of PHOTON SOURCE STRENGTH is Gy s at 1 m.
Note 2 to entry: Multiples (milli, mega, etc.) are permitted.
201.3.210
RADIOACTIVE SOURCE TRAIN
sequence of SEALED RADIOACTIVE SOURCES, possibly separated by non-RADIOACTIVE spacers,
either permanently combined or selected prior to each IRRADIATION, and used in AFTERLOADING
ME EQUIPMENT
Note 1 to entry: The RADIOACTIVE SOURCE TRAIN is usually selected to give a specified dose distribution.
201.3.211
REFERENCE AIR KERMA RATE
AIR KERMA RATE in air at a reference distance of 1 m, after correction for air ATTENUATION and
scattering

Note 1 to entry: The symbol for REFERENCE AIR KERMA RATE is K '.
R
201.3.212
SOURCE STRENGTH
PHOTON SOURCE STRENGTH, BETA SOURCE STRENGTH, or NEUTRON SOURCE STRENGTH of a
RADIATION SOURCE, whichever is applicable for the intended use of the ME EQUIPMENT
201.3.213
TRANSIT
the process through which the RADIATION SOURCES move from the STORAGE CONTAINER(S) or, in
the case of BRACHYTHERAPY X-RAY SOURCES, a reference position to a treatment position or
move from a treatment position to the STORAGE CONTAINER(S) or reference position

– 12 – 60601-2-17  IEC:2013
201.3.214
TREATMENT PARAMETER
factor that describes one aspect of the irradiation of a PATIENT during RADIOTHERAPY, such as
RADIATION ENERGY, SOURCE STRENGTH, TREATMENT TIME
201.3.215
TREATMENT TIME
the sum of the DWELL TIMES which constitute a TREATMENT
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
IEC 60601-2-8:2010, Medical electrical equipment – Part 2-8: Particular requirements for the
basic safety and essential performance of therapeutic X-ray equipment operating in the range
10 kV to 1 MV applies to AFTERLOADING ME EQUIPMENT that incorporates one or more X-RAY
TUBES.
201.4.3 ESSENTIAL PERFORMANCE
Addition:
Requirements of 201.10.1.2.101, 201.10.1.2.102, 201.10.2.101, and 201.10.2.102 are
identified as ESSENTIAL PERFORMANCE requirements.
201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
Addition:
SUPPLY MAINS in this standard shall be assumed to have the following characteristics:
– 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 ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
Addition:
201.5.101 TYPE TESTS
Appropriate care should be taken to carry out compliance tests safely, for example by using a
non-RADIOACTIVE SOURCE wherever possible. TYPE TESTS described in this particular standard
may also be used by the MANUFACTURER or by the installer as routine tests.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:

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201.6.6 Mode of operation
Replacement:
ME EQUIPMENT within the scope of this standard shall be suitable for CONTINUOUS OPERATION.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.20 Removable protective means
Replacement:
ME EQUIPMENT shall be declared as unsuitable for alternative applications that require the
removal of a protective means to utilise a particular function.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
Addition:
201.7.2.101 General
ME EQUIPMENT shall be provided with permanently affixed and clearly legible markings on
The
the appropriate part showing:
SOURCE STRENGTHS of each of the RADIONUCLIDES for which the ME
a) the maximum total
EQUIPMENT is designed, if the ME EQUIPMENT uses one or more RADIOACTIVE SOURCES;
b) the symbol ISO 361 indicating possible radiation hazard;
c) the requirement for the STORAGE CONTAINER(S) to be located only in a treatment room with
restricted access, if this is specified (see 201.10.2.101.2);
d) additional external supply requirements (e.g. compressed air), if any.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.2.102 ME EQUIPMENT with more than one RADIATION SOURCE
For ME EQUIPMENT with more than one RADIATION SOURCE, the ME EQUIPMENT shall be provided
with a permanently affixed means (e.g. a PESS) by which either the RESPONSIBLE ORGANIZATION
MANUFACTURER can indicate the RADIATION SOURCES and their configurations that can be
or the
selected for each CHANNEL.
Compliance is checked by inspection of the ME EQUIPMENT or the ACCOMPANYING DOCUMENTS.
201.7.2.103 ME EQUIPMENT with RADIOACTIVE SOURCES
Where the ME EQUIPMENT uses RADIOACTIVE SOURCES, it shall be provided with a permanently
affixed means by which either the RESPONSIBLE ORGANIZATION or the MANUFACTURER can
indicate the RADIONUCLIDE(S) that are being kept in the STORAGE CONTAINER(S) and its/their
SOURCE STRENGTH(S) on given date(s).
201.7.2.104 Interchangeable SOURCE APPLICATORS
Each interchangeable SOURCE APPLICATOR shall be permanently marked, or where appropriate,
marked on the packaging, with specific identification.

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201.7.2.105 Rigid SOURCE APPLICATORS
Each rigid SOURCE APPLICATOR with a clinically significant asymmetrical feature (e.g. curved or
partially shielded) and capable of insertion into a PATIENT in different orientations shall be so
marked that its orientation can be identified after insertion unless the ACCOMPANYING
DOCUMENTS contain a recommendation that radiographic or other appropriate checks be
carried out.
Compliance is checked by inspection of the ME EQUIPMENT or the ACCOMPANYING DOCUMENTS.
201.7.8 Indicator lights and controls
201.7.8.1 Colours of indicator lights
Replacement:
Where indicator lights are used on the TREATMENT CONTROL PANEL (TCP), or on other control
panels, the colours of the lights shall accord with those shown in Table 201.101:
Table 201.101 – Colours of lights and their meanings
Colour Meaning
Red – Immediate action required in response to an unintended state of operation
Yellow – RADIOACTIVE SOURCE(S) at the treatment position(s), or X-RAY TUBE(S) energized
Yellow – RADIOACTIVE SOURCE(S) or X-RAY TUBE(S) (if energized) in TRANSIT
(flashing)
Green – READY STATE
White – ME EQUIPMENT switched on but all the operations required to reach the READY STATE not
yet carried out
The status of the ME EQUIPMENT shall be indicated also by means other than the colour; e.g.
by the shape or location of the indicator, or by accompanying text.
For AFTERLOADING ME EQUIPMENT other than that intended to be operated in the vicinity of the
PATIENT, indicator lights in the TREATMENT ROOM, but not on the TCP, to indicate that the
RADIOACTIVE SOURCE(S) is (are) either at the treatment position(s) or in TRANSIT, or that the X-
RAY TUBE(S) is (are) energized, shall be red in colour.
NOTE This colour is required because any OPERATOR in the TREATMENT ROOM observing a red light should take
immediate action.
Compliance is checked by inspection of the ME EQUIPMENT.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 INSTRUCTIONS FOR USE
201.7.9.2.12 Cleaning, disinfection and sterilisation
Addition:
INSTRUCTIONS FOR USE shall also include a warning of the RISK that may arise during wet or
steam sterilisation whereby liquids may become trapped in cavities and subsequently
transferred to other parts of the system. This warning shall include the RISK of corrosive
damage to the SEALED RADIOACTIVE SOURCE(S) or to the BRACHYTHERAPY X-RAY SOURCE(S) and
the SOURCE DRIVE MECHANISM(S) in the event that trapped liquids are present.

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201.7.9.2.15 Environmental protection
Addition:
The instructions for use shall provide instructions for the disposal of SEALED RADIOACTIVE
SOURCE(S).
Additional subclauses:
201.7.9.2.101 Checking INTERLOCKS
INSTRUCTIONS FOR USE shall contain instructions for checking INTERLOCKS and
recommendations for the frequency of such checks.
201.7.9.2.102 Checking the security of couplings and connections
INSTRUCTIONS FOR USE shall contain instructions for the procedures to be carried out to check
the security of the connection, if any, of RADIATION SOURCE(S) to SOURCE DRIVE MECHANISM(S),
and of the couplings of CHANNEL(S) to SOURCE APPLICATOR(S).
201.7.9.2.103 Need for special procedures after a failure of a CONTROLLING TIMER
INSTRUCTIONS FOR USE shall contain an explanation of the need for special procedures after a
failure of a CONTROLLING TIMER (see 201.10.1.2.103.3.2 and 201.10.2.103.2 of this particular
standard).
201.7.9.2.104 Failure of RADIOACTIVE SOURCE to return to the STORAGE CONTAINER
INSTRUCTIONS FOR USE shall contain advice on the recommended procedures to be adopted in
the case of failure of a RADIOACTIVE SOURCE to return to the STORAGE CONTAINER and on any
emergency equipment that may be required.
201.7.9.2.105 TRANSIT ABSORBED DOSE
INSTRUCTIONS FOR USE shall contain information on AIR KERMA (or ABSORBED DOSE) at relevant
reference points during the TRANSIT from the STORAGE CONTAINER or reference position to the
TREATMENT position and the return of a specified RADIATION SOURCE.
INSTRUCTIONS FOR USE shall advise that the expected total TRANSIT dose should be determined
and, if necessary, allowed for in dose calculations.
Where appropriate, INSTRUCTIONS FOR USE shall also contain a warning that the accurate
achievement of the prescribed dose may be compromised if many TRANSITS of the RADIATION
SOURCE(S) from the STORAGE CONTAINER or reference position are carried out during the
treatment.
201.7.9.2.106 Limitations of CHANNELS and SOURCE APPLICATOR(S)
INSTRUCTIONS FOR USE shall state:
– the minimum radii of curvature for specified inside diameters of CHANNEL(S) and SOURCE
APPLICATOR(S) which are allowable for normal operation;
– the conditions of the positional arrangements of CHANNEL(S) and SOURCE APPLICATOR(S)
under which the agreement required by 201.12.1.102.1 of this particular standard is not
achieved, with an explanation of the relation to the clinical purposes for which the
ME EQUIPMENT is specified (see 201.1.1 of this particular standard);
– the nature of any obstacles of CHANNEL(S) and SOURCE APPLICATOR(S) that might impede
the free passage of RADIATION SOURCE(S) or RADIOACTIVE SOURCE TRAIN(S).

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201.7.9.2.107 Check for contamination
Where appropriate, INSTRUCTIONS FOR USE shall contain recommendations regarding
appropriate checks for leakage of radioactive material from the RADIOACTIVE SOURCE(S).
201.7.9.2.108 Asymmetric SOURCE APPLICATOR check
Where appropriate (see 201.7.2.105), INSTRUCTIONS FOR USE shall contain a recommendation
that radiographic or other checks be carried out on the orientation of asymmetric SOURCE
APPLICATOR(S).
201.7.9.2.109 Functional checks and maintenance
INSTRUCTIONS FOR USE shall contain recommendations to the RESPONSIBLE ORGANIZATION on
the regular functional checks to be performed and the required maintenance of the
ME EQUIPMENT that should ensure continued safe use, particularly on the maintenance of the
SOURCE DRIVE MECHANISM.
Where appropriate, the INSTRUCTIONS FOR USE shall include recommendations to carry out
tests using non-RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES that are not
energized.
201.7.9.2.110 Limitations on source transitions
The INSTRUCTIONS FOR USE shall contain the maximum number of transitions of the RADIATION
SOURCE(S) and of the inactive (dummy) source(s), if present, from the STORAGE CONTAINER or
reference position to the SOURCE APPLICATOR and back to the STORAGE CONTAINER or reference
position. The INSTRUCTIONS FOR USE shall also explain the necessary next steps when the limit
is reached; e.g. replacement of source or cable. If no limit on number of transitions is
imposed, the INSTRUCTION FOR USE shall state this.
201.7.9.2.111 Checking the SOURCE STRENGTH(S) of the RADIATION SOURCE(S)
Where appropriate, INSTRUCTIONS FOR USE shall contain a recommendation that a
measurement be made from which the SOURCE STRENGTH of each newly received RADIATION
SOURCE can be determined with sufficient accuracy and compared with any values used
internally by the ME EQUIPMENT.
201.7.9.3 Technical description
201.7.9.3.1 General
Addition:
The technical description shall state:
a) whether the ME EQUIPMENT is specified and intended for use only with the STORAGE
CONTAINER(S) in a TREATMENT ROOM with restricted access (see 201.10.2.101.2);
b) the RADIONUCLIDE(S), if any, the corresponding maximum SOURCE STRENGTH(S) of the
RADIOACTIVE SOURCE(S) for which the ME EQUIPMENT is designed and the corresponding
LEAKAGE RADIATION from the STORAGE CONTAINER;
c) the range of permissible configurations for the RADIOACTIVE SOURCE TRAIN(S), if any;
d) whether it is permissible to use RADIOACTIVE SOURCES from other suppliers, in which case
dimensions and tolerances of the capsules for the RADIOACTIVE SOURCES shall be stated;
e) whether it is permissible to use BRACHYTHERAPY X-RAY SOURCES from other suppliers, in
which case dimensions and tolerances of the BRACHYTHERAPY X-RAY SOURCES shall be
stated;
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f) the international standards whose requirements the RADIATION SOURCES should meet,
together with any other specific requirements;
g) whether it is permissible to have SOURCE APPLICATORS from other suppliers, in which case
relevant dimensions
...