SIST EN 60601-2-64:2015

SLOVENSKI STANDARD
01-september-2015
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Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and
essential performance of light ion beam medical equipment
Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-
Bestrahlungseinrichtungen
Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de thérapie par faisceau ionique lumineux
Ta slovenski standard je istoveten z: EN 60601-2-64:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-64

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-64: Particular requirements
for the basic safety and essential performance of light ion beam
medical electrical equipment
(IEC 60601-2-64:2014)
Appareils électromédicaux - Partie 2-64: Exigences Medizinische elektrische Geräte - Teil 2-64: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils électromédicaux par faisceau wesentlichen Leistungsmerkmale von Leichtionen-
d'ions légers Bestrahlungseinrichtungen
(IEC 60601-2-64:2014) (IEC 60601-2-64:2014)
This European Standard was approved by CENELEC on 2014-10-08. 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 60601-2-64:2015 E
Foreword
The text of document 62C/594/FDIS, future edition 1 of IEC 60601-2-64 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 60601-2-64:2015.

The following dates are fixed:
• latest date by which the document has to be (dop) 2015-11-29
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-29
• latest date by which the national
standards conflicting with the
document have to be withdrawn
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.

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 60601-2-64:2014 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:

IEC 60601-2-68 NOTE Harmonized as EN 60601-2-68.
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
Publication Year Title EN/HD Year
Annex ZA of EN 60601-1:2006 applies except as follows:
Replacement:
IEC 60601-1-2 2014 Medical electrical equipment - EN 60601-1-2 2014
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
Addition:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance
+A1 2012 + A1 2013
+ A1/AC 2014
+A12 2014
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 60601-2-11 2013 Medical electrical equipment - EN 60601-2-11 2015
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 61217 2011 Radiotherapy equipment - Coordinates, EN 61217 2012
movements and scales
ISO/IEC 14165-321 2009 Information technology - Fibre Channel - - -
Part 321: Audio-Video (FC-AV)
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.
IEC 60601-2-64 ®
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-64: Particular requirements for the basic safety and essential

performance of light ion beam medical electrical equipment

Appareils électromédicaux –
Partie 2-64: Exigences particulières pour la sécurité de base et

les performances essentielles des appareils électromédicaux par faisceau

d'ions légers
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.60 ISBN 978-2-8322-1825-9

– 2 – IEC 60601-2-64:2014  IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 45
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 45
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 46
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 46
201.15 Construction of ME EQUIPMENT . 46
201.16 ME SYSTEMS . 46
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 46
201.101 ELECTRONIC IMAGING DEVICES (EID) . 47
206 Usability . 47
Annexes . 50
Annex B (informative) Sequence of testing . 50
Annex I (informative) ME SYSTEMS aspects . 50
Bibliography . 51
Index of defined terms used in this particular standard. 52

Figure 201.101 – PATIENT SUPPORT movements . 48
Figure 201.102 – Diagram illustrating example RADIATION HEAD components and
possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 49
Figure 201.103 – Diagram illustrating distance along PATIENT plane to measure
NON-PRIMARY RADIATION ABSORBED DOSE . 49

Table 201.101 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 17

IEC 60601-2-64:2014  IEC 2014 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Particular requirements for the basic safety
and essential performance of LIGHT ION BEAM ME 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 60601-2-64 has been prepared by subcommittee 62C: Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/594/FDIS 62C/600/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 – IEC 60601-2-64:2014  IEC 2014
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 numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
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.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
IEC 60601-2-64:2014  IEC 2014 – 5 –
INTRODUCTION
The use of LIGHT ION BEAM ME 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
design does not satisfy standards of electrical and mechanical safety. The ME
EQUIPMENT
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 LIGHT ION BEAM ME EQUIPMENT for use in RADIOTHERAPY; 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 where an INTERLOCK then operates
to prevent continued operation of the ME EQUIPMENT.
Clause 201.10 contains limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE
IRRADIATION in order to insure that ESSENTIAL PERFORMANCE is maintained and to avoid an
unsafe condition. TYPE TESTS that are performed by the MANUFACTURER, or SITE TESTS, which
are not necessarily performed by the MANUFACTURER, are SPECIFIED for each requirement. 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 at installation.
Closely related to this standard is IEC 62667 which is currently being developed. It specifies
test methods and reporting formats for performance tests of LIGHT ION BEAM ME EQUIPMENT for
use in RADIOTHERAPY, with the aim of providing uniform methods of doing so. The annex of
IEC 62667 provides forms for presenting performance values, measured per the methods
SPECIFIED.
– 6 – IEC 60601-2-64:2014  IEC 2014
MEDICAL ELECTRICAL EQUIPMENT –

Particular requirements for the basic safety
and essential performance of LIGHT ION BEAM ME 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 LIGHT
ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.
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.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively
to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the
selection and DISPLAY of operating parameters can be controlled automatically by
PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in
the range 10 MeV/n to 500 MeV/n,
and
– intended to be
– 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 maintained in accordance with the
recommendations given in the INSTRUCTIONS FOR USE,
– subject to regular quality assurance performance and calibration checks by a QUALIFIED
PERSON.
NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE
ORGANIZATION’S premises.
NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).
NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their
zero positions and the direction of movement with increasing value (see 201.7.4.101).
201.1.2 Object
Replacement:
____________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

IEC 60601-2-64:2014  IEC 2014 – 7 –
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for LIGHT ION BEAM ME EQUIPMENT in the range 10 MeV/n to
500 MeV/n and to SPECIFY tests to check compliance to those requirements.
NOTE The adoption of this standard helps to ensure that the ME EQUIPMENT
– maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS;
– delivers the pre-selected RADIATION TYPE, ENERGY PER NUCLEON, LIGHT ION species, and ABSORBED DOSE;
– delivers pre-selected LIGHT ION BEAMS to the PATIENT, by utilizing LIGHT ION BEAM modifying devices, etc.,
without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.
201.1.3 Collateral standards
Addition:
Collateral standards published after the date of publication of this standard shall only apply
subject to further amendment to this standard.
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 60601-1-6 applies as modified in Clause 206. IEC 60601-1-3, IEC 60601-1-8,
2 3
IEC 60601-1-9 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601-1 series apply as published.
NOTE Collateral standards published after the date of publication of this standard will only apply subject to further
amendment to this standard.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard or 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.
____________
IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for environmentally conscious design
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

– 8 – IEC 60601-2-64:2014  IEC 2014
“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:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
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 60601-2-11:2013, 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 61217:2011, Radiotherapy equipment – Coordinates, movements and scales
ISO/IEC 14165-321:2009, Information technology – Fibre channel – Part 321: Audio video
(FC-AV)
NOTE Informative references are listed in the bibliography.

IEC 60601-2-64:2014  IEC 2014 – 9 –
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1:
2012, IEC 60601-2-1: 2009, and IEC TR 60788:2004 apply, except as follows:
Additional definitions:
201.3.201
APPLICATOR CARRIAGE
the most distal part of the RADIATION HEAD that can not be removed without using tools to
which interchangeable LIGHT ION BEAM APPLICATORS are attached and which may extend
toward and retract away from the ISOCENTRE or ERP.
Note 1 to entry: Colloquially the APPLICATOR CARRIAGE has sometimes been called a snout.
201.3.202
BEAM FLUENCE DISTRIBUTION MONITOR
system to monitor directly or indirectly the FLUENCE distribution of the beam to provide beam
steering or lateral spreading information
Note 1 to entry: This monitor may be used as a surrogate monitor for the DOSE distribution delivered to the
patient.
Note 2 to entry: Examples of BEAM FLUENCE DISTRIBUTION MONITORS include quadrant foil ionization chambers,
concentric ring ionization chambers, multi-strip ionization chambers, scintillator plates, and scanning magnet field
probes.
201.3.203
BEAM FLUX MONITOR
system to monitor the FLUX of the beam
Note 1 to entry: This monitor may be used as a surrogate monitor for the DOSE rate delivered to the patient.
201.3.204
BEAM GATING
allowance or inhibition of IRRADIATION and related equipment movements according to the
status provided by a BEAM GATING SIGNAL
201.3.205
BEAM GATING SIGNAL
signal generated for the purpose of BEAM GATING
EXAMPLE Examples include a respiratory spirometer, electrocardiogram, optical sensor, etc.
201.3.206
CONTROLLING TIMER
device to measure the time during which IRRADIATION occurs and, if a predetermined time is
reached, to TERMINATE IRRADIATION
[SOURCE: IEC 60601-2-1: 2009, 201.3.202]
201.3.207
DOSE MONITOR UNIT
a parameter, reported by the DOSE MONITORING SYSTEM, from which, through a calibration
procedure and with additional information, the ABSORBED DOSE delivered can be calculated
201.3.208
DOSE MONITOR UNIT RATE
DOSE MONITOR UNIT per unit time

– 10 – IEC 60601-2-64:2014  IEC 2014
201.3.209
DOSE MONITOR UNIT RATE MONITORING SYSTEM
system of devices for the measurement and DISPLAY of a radiation quantity related to DOSE
MONITOR UNIT RATE
201.3.210
DOSE MONITORING SYSTEM
system of devices for the measurement and DISPLAY of a radiation quantity related to the
ABSORBED DOSE
201.3.211
ENERGY PER NUCLEON
the total kinetic energy of the ion divided by the number of nucleons in the nucleus at the
point where the ion enters the RADIATION HEAD before passing through any beam modifiers
201.3.212
EQUIPMENT REFERENCE POINT
ERP
point in space used for referencing dimensions of equipment and performing dosimetry
measurements
Note 1 to entry: Typically the reference point is coincident with the ISOCENTRE. If the beam delivery equipment is
not ISOCENTRIC, then the centre of the PATIENT alignment systems may be used.
Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation "ERP" stands
for "EQUIPMENT REFERENCE POINT" in English.
201.3.213
FLUENCE
particles per unit area
Note 1 to entry: See ICRU 33, ICRU 85a.
201.3.214
FLUX
particles per unit time
Note 1 to entry: See ICRU 33, ICRU 85a.
201.3.215
HARD-WIRED
term used where the features of a system can be modified only by physically removing and
re-routing wires
[SOURCE: IEC 60601-2-1: 2009, 201.3.208]
201.3.216
INTERRUPTION OF IRRADIATION
TO INTERRUPT IRRADIATION
stopping of/to stop IRRADIATION and movements with the possibility of continuing without
reselecting operating conditions
[SOURCE: IEC 60601-2-1: 2009, 201.3.210]
201.3.217
LATERAL SPREADING DEVICE
LSD
device used to increase the lateral (x , y ) dimensions of a small diameter LIGHT ION BEAM
b b
produced by an accelerator
IEC 60601-2-64:2014  IEC 2014 – 11 –
EXAMPLE Examples of spreading devices include a thin metal foil for scattering the ions or a magnet to defocus
the beam or to scan the beam laterally across the intended target.
Note 1 to entry: X and y are defined in IEC 61217:2011.
b b
201.3.218
LIGHT ION
species of ion with an atomic number less than or equal to that of neon (Z ≤ 10) and SPECIFIED
by its number of protons, number of nucleons and ionization state
201.3.219
LIGHT ION BEAM
collection of LIGHT IONS travelling in the same general direction
201.3.220
LIGHT ION BEAM APPLICATOR
device for holding a BEAM LIMITING DEVICE or ACCESSORY close to the PATIENT's skin during
delivery of LIGHT ION beam
Note 1 to entry: Several BEAM APPLICATORS may be available to reduce the weight of apertures lifted by therapists,
decrease the aperture/bolus to skin distance and reduce leakage radiation.
201.3.221
LIGHT ION BEAM DISTRIBUTION SYSTEM
system of components and a control system used to transport the RADIATION from a RADIATION
SOURCE to several TREATMENT stations, experimental stations or beam dumps
EXAMPLE Examples of components include vacuum pipes, magnets, and steering coils.
201.3.222
LIGHT ION RANGE
the depth in a PHANTOM most distant from its surface at which the ABSORBED DOSE is a
SPECIFIED value, given in the ACCOMPANYING DOCUMENTS, of the dose at the nominal
centre-of-modulation depth or of the dose maximum for a non-range-modulated beam, which
is measured on the RADIATION BEAM AXIS in a SPECIFIED RADIATION FIELD and with the surface of
the PHANTOM at a SPECIFIED distance from the ERP without RANGE SHIFTERS or ACCESSORIES
installed in the RADIATION HEAD downstream of the ENERGY PER NUCLEON or range monitoring
system
201.3.223
MODULATED SCANNING
SCANNING MODE wherein a small diameter LIGHT ION BEAM is scanned across a target to create
a field large enough to cover the target such that the intended FLUENCE delivered to the
PATIENT is different at different lateral locations
Note 1 to entry: Various spatial and temporal scanning patterns may be used to generate the modulated FLUENCE
distribution.
201.3.224
NON-PRIMARY RADIATION
RADIATION emitted from the LIGHT ION BEAM ME EQUIPMENT that is not intended to treat the
PATIENT
201.3.225
NORMAL USE
operation, including routine inspection and adjustments by the OPERATOR, and STAND-BY,
according to the instructions for use
Note 1 to entry: NORMAL USE includes PATIENT TREATMENT, equipment calibration, quality assurance procedures,
maintenance, and other procedures performed by the OPERATOR required in preparation for PATIENT TREATMENTS.
[SOURCE: IEC TR 60788:2004, NG, 10.08, modified – A note to entry has been added.]

– 12 – IEC 60601-2-64:2014  IEC 2014
201.3.226
OPERATOR
person utilizing an EQUIPMENT individually with or without the aid of an assistant, who controls
some or all functions of the EQUIPMENT in his presence
[SOURCE: IEC TR 60788:2004, rm-85-02]
201.3.227
PATIENT SUPPORT
assembly of ME EQUIPMENT that supports the PATIENT
[SOURCE: IEC TR 60601-2-1:2009, 201.3.215]
201.3.228
PORTAL
collection of one or more pre-programmed treatment segments treated automatically with a
single PATIENT set-up
Note 1 to entry: Segments may consist of treatment beam IRRADIATION, motion of devices, or imaging.
201.3.229
PRE-PROGRAMMED MOVEMENTS
movement of ME EQUIPMENT parts that takes place according to a previously planned
programme without intervention by the OPERATOR during a PATIENT treatment or imaging
201.3.230
PRIMARY/SECONDARY DOSE MONITORING COMBINATION
utilization of two DOSE MONITORING SYSTEMS where one is arranged to be the PRIMARY and the
other the SECONDARY DOSE MONITORING SYSTEM
201.3.231
PROGRAMMABLE RANGE MODULATED PORTAL
PRMP
a LIGHT ION PORTAL in which a RANGE MODULATION DEVICE or program is used to tailor the
DEPTH DOSE distribution by varying the penetration and weighting factors of several
component segments
Note 1 to entry: Typically the DEPTH DOSE distribution is tailored to give a uniform dose distribution over the
depths where the target (tumour) resides.
Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation "PRMP" stands
for "PROGRAMMABLE RANGE MODULATED PORTAL" in English.
201.3.232
RADIATION HEAD
structure from which the RADIATION BEAM emerges
[SOURCE: IEC TR 60788:2004, rm-20-06]
201.3.233
RANGE MODULATION DEVICE
RMD
device used to modulate the penetration of a beam into a PATIENT to tailor the DEPTH DOSE
distribution during the delivery of one PORTAL
Note 1 to entry: The device may consist of a propellor shaped material that spins in the beam, a filter containing a
repeating pattern of metallic ridges (e.g. ridge filter, mini-ridge filter, ripple filter), a cone or set of cones, or a set of
uniform thickness blocks programmable in a binary fashion. Sub-types include discrete and programmable.
Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation "RMD" stands
for "RANGE MODULATION DEVICE" in English.

IEC 60601-2-64:2014  IEC 2014 – 13 –
201.3.234
RANGE SHIFTER
range modifying device that has a constant thickness at all positions lateral to the central axis
of the beam
201.3.235
REDUNDANT DOSE MONITORING COMBINATION
utilization of two DOSE MONITORING SYSTEMS where both systems are arranged to TERMINATE
IRRADIATION according to the pre-selected number of DOSE MONITOR UNITS
201.3.236
SCANNING MODE
method of delivering a scanned beam to generate a laterally broad field
Note 1 to entry: Types of SCANNING MODES include: UNIFORM SCANNING and MODULATED SCANNING.
201.3.237
SITE TEST
after installation, test of an individual device or ME EQUIPMENT to establish compliance with
SPECIFIED criteria
Note 1 to entry: It is understood that SITE TESTS shall be performed but may or may not be performed by the
MANUFACTURER, per the agreement between the MANUFACTURER and the end USER.
[SOURCE: IEC 60601-2-1:2009, 201.3.221, modified – The note to entry has been added.]
201.3.238
TABLE TOP
an exchangeable device attached to the patient positioner to which registration and
immobilization devices are attached and upon which the patient is placed.
201.3.239
TECHNICAL DOCUMENTATION
documentation that enables the conformity of the product with the requirements of the
standard(s) to be assessed
Note 1 to entry: This may include schedule drawings when a certification body is involved.
Note 2 to entry: It covers the design, manufacture and operation of the product and may contain:
– a general description;
– design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
– descriptions and explanations necessary for the understanding of drawings and layouts and the operation of
the product;
– a list of the standards referred to in the Ex certificate, applied in full or in part, and descriptions of the
solutions adopted to meet the requirements of the standards;
– results of design calculations made, examinations carried out, etc.;
– test reports
Note 3 to entry: The technical description includes information derived from the TECHNICAL DOCUMENTATION.
[SOURCE: ISO/IEC 80079-34:2011, 3.12, modified – A third note to entry has been added.]
201.3.240
TERMINATION OF IRRADIATION
TERMINATE IRRADIATION
stopping of/to stop IRRADIATION and movements, with no possibility of restarting without
returning to the PREPARATORY STATE
Note 1 to entry: Examples of events that may TERMINATE IRRADIATION and stop movements include:
– when the pre-selected value of DOSE MONITOR UNITS is reached,

– 14 – IEC 60601-2-64:2014  IEC 2014
– when the pre-selected value is reached in the termination system independent of the DOSE MONITORING
SYSTEM,
– by a deliberate manual act,
– by the operation of an INTERLOCK, or
– in MODULATED SCANNING, when pre-programmed scanning pattern is completed
[SOURCE: IEC 60601-2-11:2013, 201.3.225, modified – The wording of both the definition
and the note to entry is slightly different.]
201.3.241
TRANSMISSION DETECTOR
RADIATION DETECTOR through which the LIGHT ION BEAM passes
[SOURCE: IEC 60601-2-1:2009, 201.3.226, modified – The term "RADIATION BEAM" has been
replaced by "LIGHT ION BEAM".]
201.3.242
TYPE TEST
test on a representative sample of the equipment with the objective of determining if the
equipment, as designed and manufactured, can meet the requirements of this standard
[SOURCE: IEC 60601-1:2005, 3.135]
201.3.243
UNIFORM SCANNING
SCANNING MODE wherein a RADIATION BEAM is scanned laterally in a pre-defined pattern to
produce a field large enough to treat the target such that the FLUX of the beam is not
intentionally changed throughout the lateral scan so that the resultant dose distribution within
the field is uniform
Note 1 to entry: The scanning may be accomplished by changing the current in electromagnets through which the
beam passes or permanent magnets mechanically rotated or translated.
201.3.244
USER
when used in an IEC standard on eletromedical EQUIPMENT, organization or individual
responsible for the use and maintenance of the EQUIPMENT
[SOURCE: IEC TR 60788:2004, rm-85-01]
201.4 General requirements
Clause 4 of the general standard applies.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies except as follows:
201.5.1 TYPE TESTS
Replacement of the title:
201.5.1 TYPE TESTS and SITE TESTS
Additional subclause:
IEC 60601-2-64:2014  IEC 2014 – 15 –
201.5.1.101 Test grades
Three grades of TYPE TEST and two grades of SITE TEST procedures are SPECIFIED in this
particular standard. Their requirements are as follows:
– TYPE TEST grade A: An analysis of ME EQUIPMENT design, as related to the SPECIFIED
RADIATION safety provisions, which shall result in a statement included in the
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