IEC 60601-2-64:2014
(Main)Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
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 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of 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, 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. Key words: nuclear medicine, radiation dosimetry.
Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers
L'IEC 60601-2-64:2014 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux par Faisceau d'Ions Légers, désignés ci-après par le terme appareils EM, utilisés pour le traitement des patients. La présente norme particulière, y compris les essais de type et les essais sur le site, s'applique respectivement au fabricant et à certains aspects d'installation des appareils EM par Faisceau d'Ions Légers destinés à être utilisés à des fins de radiothérapie dans la médecine humaine, y compris les appareils dont le choix et l'affichage des paramètres de fonctionnement peuvent être contrôlés automatiquement par des sous-systèmes électroniques programmables qui, en utilisation normale, délivrent un faisceau de rayonnement d'ions légers dont l'énergie par nucléon se situe dans la gamme 10 MeV/n à 500 MeV/n. Mots clé: médecine nucléaire, dosimétrie de radiations.
General Information
Relations
Standards Content (Sample)
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 14
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 55 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.
Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient plus de 30 000 termes et définitions en
Spécifications techniques, Rapports techniques et autres
anglais et en français, ainsi que les termes équivalents dans
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
14 langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.
Recherche de publications IEC - www.iec.ch/searchpub
Glossaire IEC - std.iec.ch/glossary
Plus de 55 000 entrées terminologiques électrotechniques, en
La recherche avancée permet de trouver des publications IEC
en utilisant différents critères (numéro de référence, texte, anglais et en français, extraites des articles Termes et
comité d’études,…). Elle donne aussi des informations sur les Définitions des publications IEC parues depuis 2002. Plus
projets et les publications remplacées ou retirées. certaines entrées antérieures extraites des publications des
CE 37, 77, 86 et CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished
Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just
Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
csc@iec.ch.
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
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.
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
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.
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
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.
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:
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 technical
description, regarding the working principles or constructional means by which the
requirement is fulfilled.
– TYPE TEST/SITE TEST grade B: Visual inspection or functional test or measurement of the ME
EQUIPMENT. The test shall be 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
MANUFACTURER or his agent.
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 end USER.
201.5.4 Other conditions
Replacement:
The MANUFACTURER shall state in the ACCOMPANYING DOCUMENTS any additional requirements
for testing.
201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
201.5.9.2.1 Test finger
Addition:
Where the nature of the installation renders parts inaccessible per the test with the standard
test finger and they can only be made accessible by use of a TOOL, those parts will not be
considered ACCESSIBLE PARTS. The ACCOMPANYING DOCUMENTS shall describe such situations.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
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
201.7.2.4 ACCESSORIES
Addition:
The maximum aperture opening supported by non-PATIENT SPECIFIC BEAM LIMITING DEVICES
(BLD) shall be clearly legible on the outside of all interchangeable and non-adjustable BLDs
and BEAM APPLICATORS.
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...