IEC 60601-2-1:2009
(Main)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
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 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators 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 medical electrical equipment. It places limits on the degradation of medical electrical 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. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions:
- alignment with the new relevant collateral standards;
- new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).
Appareils électromédicaux - Partie 2-1: Exigences particulières de sécurité de base et de performances essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV
La CEI 60601-2-1:2009 s'applique à la sécurité de base et aux performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV, et utilisés pour le traitement des patients. La présente norme particulière décrit les exigences auxquelles il convient que les fabricants se conforment dans la conception et la construction des accélérateurs d'électrons utilisés en radiothérapie; elle ne vise pas à définir des exigences de performances optimales. Son objet est d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils électromédicaux. Elle fixe des limites de détérioration des performances des appareils électromédicaux qui seraient la conséquence d'une condition de défaut, pour lesquelles un verrouillage doit entrer en action pour empêcher l'appareil em de continuer à fonctionner. Cette troisième édition annule et remplace la deuxième édition publiée en 1998 et son Amendement 1 (2002). Elle constitue une révision technique. Cette troisième édition aborde les questions suivantes non traitées dans les éditions antérieures:
- l'alignement avec les nouvelles normes collatérales pertinentes;
- les nouvelles technologies en radiothérapie, y compris la radiochirurgie stéréotaxique (SRT) et la radiothérapie stéréotaxique (SRS), la radiothérapie de conformation avec modulation d'intensité de dose (IMRT), les dispositifs d'imagerie numérique et la radiothérapie cinétique (thérapie dynamique).
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IEC 60601-2-1 ®
Edition 3.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
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IEC 60601-2-1 ®
Edition 3.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.60 ISBN 978-2-88910-212-9
– 2 – 60601-2-1 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.7
201.1 Scope, object and related standards .8
201.2 Normative references.10
201.3 Terms and definitions.11
201.4 General requirements .14
201.5 General requirements for testing 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 .21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .22
201.10 Protection against unwanted and excessive radiation HAZARDS .25
201.11 Protection against excessive temperatures and other HAZARDS .47
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .47
201.13 HAZARDOUS SITUATIONS and fault conditions .47
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47
201.15 Construction of ME EQUIPMENT .48
201.16 ME SYSTEMS .48
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS .48
206 Usability.50
Annexes .59
Annex B (informative) Sequence of testing .59
Annex I (informative) ME SYSTEMS aspects .59
Bibliography.60
Index of defined terms .61
Figure 201.101 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION
(201.10.1.2.102.1) .51
Figure 201.102 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION
(201.10.1.2.102.2) .
Figure 201.103 – Elevation view – Application of LEAKAGE RADIATION requirements
(201.10.1.2.103 and 201.10.1.2.104) .53
Figure 201.104 – 24 measurement points for averaging LEAKAGE RADIATION during X-
RADIATION (201.10.1.2.103.2.1) .54
Figure 201.105 – Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during
ELECTRON IRRADIATION (201.10.1.2.103.2.2).55
Figure 201.106 – Measurement points for averaging LEAKAGE RADIATION during
ELECTRON IRRADIATION (201.10.1.2.103.2.2).56
Figure 201.107 – 24 measurement points for averaging LEAKAGE RADIATION outside
area M (201.10.1.2.103.3).57
Figure 201.108 – ME EQUIPMENT movements and scales .58
Table 201.101 – Colours of indicator lights and their meaning for ME EQUIPMENT.16
60601-2-1 © IEC:2009 – 3 –
Table 201.102 – Data required in the technical description to support Clause 201.10
SITE TEST compliance .18
Table 201.103 – Clauses and subclauses in this particular standard that require the
provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and
the technical description .20
Table 201.104 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION (see
Figure 201.101) .39
Table 201.105 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see
Figure 201.102) .39
– 4 – 60601-2-1 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
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 60601-2-1 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 1998 and its
Amendment 1 (2002). It constitutes a technical revision.
60601-2-1 © IEC:2009 – 5 –
This third edition addresses the following issues not covered in previous editions:
– alignment with the new relevant collateral standards;
– new technologies in radiotherapy, including:
• stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT);
• intensity modulated radiotherapy (IMRT);
• electronic imaging devices (e.g. EPID);
• moving beam radiotherapy (dynamic therapy).
The text of this particular standard is based on the following documents:
FDIS Report on voting
62C/474/FDIS 62C/480/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 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.
– 6 – 60601-2-1 © IEC:2009
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
60601-2-1 © IEC:2009 – 7 –
INTRODUCTION
The use of ELECTRON ACCELERATORS for RADIOTHERAPY purposes may expose PATIENTS to
danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME
EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The ME
EQUIPMENT may also cause danger to persons in the vicinity if the ME EQUIPMENT itself fails to
contain the RADIATION adequately and/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 ELECTRON ACCELERATORS 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 ESSENTIAL PERFORMANCE is maintained to avoid an unsafe
condition. TYPE TESTS that are performed by the MANUFACTURER, and/or SITE TESTS, which are
not necessarily performed by the MANUFACTURER, are SPECIFIED for each requirement. It is
understood that SITE TESTS may or may not be required of the MANUFACTURER, per the
agreement between the MANUFACTURER and end user.
Given that before installation a MANUFACTURER cannot provide SITE TEST data, 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.
This International Standard was first published in 1981. It was amended in 1984 and 1990. A
second edition was published in 1998 and amended in 2002. This third edition is prompted by
the need to align this particular standard with the third edition of the general standard,
IEC 60601-1:2005.
IEC 60976 and IEC/TR 60977 are closely related to this standard. The former specifies test
methods and reporting formats for performance tests of ELECTRON ACCELERATORS for use in
RADIOTHERAPY, with the aim of providing uniform methods for conducting such tests. The latter
is not a standard per se, but suggests performance values, measured per the methods
specified in IEC 60976, that could be achievable with present technology.
– 8 – 60601-2-1 © IEC: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
201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE of
This International Standard applies to the
ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to
50 MeV, 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 ELECTRON ACCELERATORS
– 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, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-
RADIATION and/or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
–1 –1
ABSORBED DOSE RATES between 0,001 Gy × s and 1 Gy × s at 1 m from
• maximum
the RADIATION SOURCE,
• NORMAL TREATMENT DISTANCES (NTDs) between 0,5 m and 2 m from the RADIATION
SOURCE,
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, e.g. STATIONARY RADIOTHERAPY or MOVING
BEAM RADIOTHERAPY,
• 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.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
60601-2-1 © IEC:2009 – 9 –
IEC 61271 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).
IEC 60676 specifies methods of testing and disclosure of functional performance of medical
ELECTRON ACCELERATORS. The standard is intended to facilitate comparisons of accelerator-
based ME EQUIPMENTs of different manufacture. IEC 60676 contains no safety requirements,
and is therefore not required for compliance with this particular standard. It should also be
noted (as stated in the Introduction to IEC 60976:2007) that tests specified in IEC 60976 are
not necessarily appropriate for ensuring that any individual medical ELECTRON ACCELERATOR
conforms to the declared functional performance during the course of its working lifetime.
NOTE 3 IEC/TR 60977, Medical electrical equipment – Medical electron accelerators – Guidelines for functional
performance characteristics, is a related technical report that provides performance guidelines. It shall not be
construed as a standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ELECTRON ACCELERATORS in the range 1 MeV to 50 MeV 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, NOMINAL ENERGY, and ABSORBED DOSE,
• delivers the RADIATION in accordance with the pre-selected relationship of the RADIATION BEAM to the PATIENT,
by utilizing STATIONARY RADIOTHERAPY, MOVING BEAM RADIOTHERAPY, RADIATION 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 apply as modified in Clauses 206. IEC 60601-1-3, IEC 60601-1-8 and 60601-
1-10 do not apply. All other published collateral standards in the IEC 60601-1 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
– 10 – 60601-2-1 © IEC:2009
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 sections, 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 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3
collateral standard, etc.). The changes to the text of the general standard are specified by the
use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the bibliography on page 60.
Addition:
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms (available in
English only)
IEC 61217:1996, Radiotherapy equipment – Coordinates, movements and scales
60601-2-1 © IEC:2009 – 11 –
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, and
IEC/TR 60788:2004 apply, except as follows:
NOTE An index of defined terms is to be found at the end of the document.
Addition:
201.3.201
AMBIENT DOSE EQUIVALENT
H*(10)
DOSE EQUIVALENT at the point of interest in the actual RADIATION FIELD defined as DOSE
EQUIVALENT which would be generated in the associated oriented and expanded RADIATION
FIELD at a depth of 10 mm on the radius of the ICRU sphere which is oriented opposite to the
direction of incident RADIATION
NOTE 1 An oriented and expanded RADIATION FIELD is an idealized RADIATION FIELD which is expanded and in
which the radiation is additionally oriented in one direction.
NOTE 2 See also ICRU definition of AMBIENT DOSE EQUIVALENT in ICRU Report 39.
201.3.202
CONTROLLING TIMER
device to measure the time during which IRRADIATION occurs and, if a predetermined time is
reached, TO TERMINATE IRRADIATION
201.3.203
ELECTRON BEAM APPLICATOR
BEAM LIMITING DEVICE for ELECTRON RADIATION beams
201.3.204
ELECTRONIC IMAGING DEVICE
EID
device consisting of one or more RADIATION DETECTORS and associated electronics, which
enables anatomical structures of a PATIENT to be viewed as a digital radiograph at a viewing
screen
[IEC 60976:2007, definition 3.5]
201.3.205
ELECTRONIC PORTAL IMAGING DEVICE
EPID
device consisting of a two-dimensional RADIATION DETECTOR and associated electronics,
placed substantially normal to the RADIATION BEAM AXIS, which enables anatomical structures
of a PATIENT to be viewed as a digital radiograph at a viewing screen, using the medical
ELECTRON ACCELERATOR'S RADIATION BEAM as the RADIATION SOURCE
NOTE 1 The primary function of an EPID is in verification of PATIENT set-up, and so replaces the need for port
films for this same purpose.
[IEC 60976:2007, definition 3.6]
NOTE 2 This definition is not included in IEC/TR 60788.
201.3.206
GANTRY
part of the ME EQUIPMENT supporting the RADIATION HEAD
– 12 – 60601-2-1 © IEC:2009
201.3.207
GEOMETRICAL RADIATION FIELD
geometrical projection of the distal end of the BEAM LIMITING DEVICE on a plane orthogonal to
the REFERENCE AXIS, as seen from the centre of the front surface of the TARGET/ELECTRON
RADIATION window; the GEOMETRICAL RADIATION FIELD may be defined at any distance from the
front surface of the TARGET for X-RADIATION, or from the ELECTRON RADIATION window for
ELECTRON RADIATION
201.3.208
HARD-WIRED
term used where the features of a system can be modified only by physically removing and re-
routing wires
201.3.209
INTENSITY MODULATION RADIATION THERAPY
IMRT
treatment procedure requiring, in general, the coordinated control of photon or electron
fluence, beam orientation relative to the PATIENT, and beam size of the external beam, either
in a continuous or a discrete manner, and as pre-determined by a treatment plan
NOTE The primary purpose of IMRT is to improve the conformity of the dose distribution to the planned TARGET
VOLUME, while minimizing dose to surrounding healthy tissue.
201.3.210
INTERRUPTION OF IRRADIATION/TO INTERRUPT IRRADIATION
stopping of/to stop IRRADIATION and movements with the possibility of continuing without
reselecting operating conditions
201.3.211
MOVING BEAM RADIOTHERAPY
RADIOTHERAPY with any planned displacement of the RADIATION FIELD or PATIENT relative to
each other or with any planned change of ABSORBED DOSE distribution
201.3.212
NOMINAL ENERGY
ENERGY
ENERGY stated by the MANUFACTURER to characterize the RADIATION
BEAM
ENERGY stated by the MANUFACTURER to characterize the radiation BEAM
201.3.213
NORMAL TREATMENT DISTANCE
NTD
SPECIFIED distance measured along the REFERENCE AXIS from the
ELECTRON RADIATION window to the distal end of the ELECTRON BEAM APPLICATOR or to a
SPECIFIED plane
SPECIFIED distance measured along the REFERENCE AXIS from the front surface
of the TARGET to the ISOCENTRE or, for ME EQUIPMENT without an ISOCENTRE, to a SPECIFIED
plane
201.3.214
PASSWORD
sequence of keystrokes that permits OPERATOR access for NORMAL USE or to
reset INTERLOCKS and, with a different sequence of keystrokes, permits access for adjustment
and maintenance
60601-2-1 © IEC:2009 – 13 –
201.3.215
PATIENT SUPPORT
assembly of ME EQUIPMENT that supports the PATIENT
201.3.216
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
201.3.217
QUALIFIED PERSON
person recognised by a competent authority as having the requisite knowledge and training to
perform particular duties
201.3.218
RADIATION TYPE
nature of the waves or corpuscles comprising the RADIATION
NOTE E.g. whether the RADIATION is X-RADIATION or ELECTRON RADIATION.
201.3.219
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
201.3.220
RELATIVE SURFACE DOSE
ratio of the ABSORBED DOSE on the REFERENCE AXIS, at the depth of 0,5 mm, to the maximum
ABSORBED DOSE on the REFERENCE AXIS, both measured in a PHANTOM with its surface at a
SPECIFIED distance
201.3.221
SITE TEST
after installation, test of an individual device or ME EQUIPMENT to establish compliance with
SPECIFIED criteria
201.3.222
STEREOTACTIC RADIOTHERAPY
SRT
treatment procedure in which RADIATION BEAMS of generally small size are oriented from
various angles, and precisely positioned relative to a TARGET VOLUME within the PATIENT
NOTE Precise location of the TARGET VOLUME is enabled by use of a three-dimensional frame of reference, which
may include anatomical registration points or markers, and immobilisation methods, or imaging techniques.
201.3.223
STEREOTACTIC RADIOSURGERY
SRS
SPECIFIC version of STEREOTACTIC RADIOTHERAPY, in which a single high dose of RADIATION is
delivered to the TARGET VOLUME, using a STEREOTACTIC FRAME OF REFERENCE in conjunction
with anatomical registration points
201.3.224
STEREOTACTIC FRAME OF REFERENCE
three-dimensional coordinate system for numerical specification of the position of those parts
of a PATIENT anatomy intended for SRS/SRT treatment
– 14 – 60601-2-1 © IEC:2009
201.3.225
TERMINATION OF IRRADIATION
TERMINATE IRRADIATION
stopping of/to stop IRRADIATION and movements, with no possibility of restarting without the
reselection of all operating conditions
NOTE 1 I.e. returning/to return to the PREPARATORY STATE.
NOTE 2 Events that TERMINATE IRRADIATION and stop movements include the following:
• when the pre-selected value of DOSE MONITOR UNITS is reached,
• when the pre-selected value of elapsed time is reached,
• a deliberate manual act,
• the operation of an INTERLOCK,
• in MOVING BEAM RADIOTHERAPY, when the pre-selected value of an angular or linear dimension is exceeded.
201.3.226
TRANSMISSION DETECTOR
RADIATION DETECTOR through which the RADIATION BEAM passes
201.3.227
TYPE TEST
ME EQUIPMENT test by the MANUFACTURER to establish compliance with SPECIFIED criteria for a
particular design of device or ME EQUIPMENT
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
Requirements of 201.10 are identified as ESSENTIAL PERFORMANCE requirements.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.1 TYPE TESTS
Additional subclause:
201.5.1.101 Test grades
Three grades of TYPE TEST and two of SITE TEST procedures are SPECIFIED in 201.10 of 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,
60601-2-1 © IEC:2009 – 15 –
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.
201.5.4 Other conditions
Replacement:
The MANUFACTURER shall state in the ACCOMPANYING DOCUMENTS any additional requirement
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:
201.7.2.4 ACCESSORIES
Addition:
The dimensions of the GEOMETRICAL RADIATION FIELD at NTD and the distance from the distal
end to NTD shall be clearly legible on the outside of all interchangeable and non-adjustable
BEAM LIMITING DEVICES (BLDs) and ELECTRON BEAM APPLICATORS.
Each manually interchangeable WEDGE FILTER shall be clearly marked to establish its identity.
201.7.2.20 Removable protective means
Addition:
Where the requirements of the subclause of the general standard are wholly or partly met by
the nature of the installation, compliance at installation should be checked by inspection; the
results should be included in the SITE TEST report.
201.7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
– 16 – 60601-2-1 © IEC:2009
201.7.3.101 RADIATION HEAD
Removal of the covers of the RADIATION HEAD shall expose symbol 11 of Table D.1 of the
general standard, indicating "Attention, consult ACCOMPANYING DOCUMENTS".
201.7.4 Marking of controls and instruments
Additional subclause:
201.7.4.101 Provision of scales and indications for moving parts
The following shall be provided:
a) a mechanical scale or a numerical indication for each available movement;
b) a means to align the PATIENT with respect to the REFERENCE AXIS (e.g. LIGHT FIELD, lasers
etc.);
c) a means to determine RADIATION SOURCE TO SKIN DISTANCE (e.g. scale, numerical
indication, or lasers).
The designation, direction of increasing value and zero position of all movements shall comply
with IEC 61217 (see Figure 201.108).
Compliance is checked by inspection.
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 other control
panels, the colours of the lights shall accord with the following:
RADIATION BEAM "on" yellow
READY STATE green
NOTE In the TREATMENT ROOM or at other locations, these states may require urgent action or caution; different
colours, in accordance with the Table 201.101 below, may therefore be used in such locations.
Table 101.101 – Colours of indicator lights and their meaning
for ME EQUIPMENT
Colour Meaning
Red Warning – immediate response by the OPERATOR is required
Yellow Caution – prompt response by the OPERATOR is required
Green Ready for use
Any other colour Meaning other than that of red, yellow or green
Urgent action required in response to an unintended state of operation red
PREPARATORY STATE other colour
201.7.9 ACCOMPANYING DOCUMENTS
Addition:
60601-2-1 © IEC:2009 – 17 –
Data required in the technical description to support Clause 201.10 SITE TEST compliance is
given in Table 201.102.
– 18 – 60601-2-1 © IEC:2009
Table 201.102 – Data required in the technical description to support
Clause 201.10 SITE TEST compliance
Compliance Statement regarding Details of, and results Details of, and results SPECIFIC procedures SPECIFIC procedures
subclause data from TYPE TESTS from, TYPE TESTS from, TYPE TESTS and test conditions and test conditions
grade A grade B grade C for SITE TESTS grade B for SITE TESTS grade C
201.10.1.2.101.1.2 b) d) e) d) a) b) c)
201.10.1.2.101.1.3 a) b) b) c) b)
201.10.1.2.101.1.4 d) e) f) a) b) c) d) e) f)
201.10.1.2.101.1.5 a) b)
201.10.1.2.101.1.6 a) b) c) d) b) c) d)
201.10.1.2.101.1.7 a) b)
201.10.1.2.101.2 a) b) c) a) d) b) c)
201.10.1.2.101.3 b) c) d) e) a) b) c) d) e)
201.10.1.2.101.4 a) b) c) d) e) a) b) c) d) e)
201.10.1.2.101.5 c) c) a) b)
201.10.1.2.101.6 c) f) d) e) a) b) c) d) e) f)
201.10.1.2.101.7.1 a) b)
201.10.1.2.101.7.2 a) c) b)
201.10.1.2.101.7.3.1 † †
201.10.1.2.101.7.3.2 a) c) d) b)
201.10.1.2.101.8 a) b) c) d) e) f) g)
201.10.1.2.101.9 a) a)
201.10.1.2.101.10 e) a) b) c) d) e)
201.10.1.2.101.11 †
201.10.1.2.101.12 a) c) a) b) c) d)
201.10.1.2.101.13 a) a) b)
201.10.1.2.101.14 a) b) a) b)
201.10.1.2.102.1 † †
201.10.1.2.102.2 † †
60601-2-1 © IEC:2009 – 19 –
Compliance Statement regarding Details of, and results Details of, and results SPECIFIC procedures SPECIFIC procedures
subclause data from TYPE TESTS from, TYPE TESTS from, TYPE TESTS and test conditions and test conditions
grade A grade B grade C for SITE TESTS grade B for SITE TESTS grade C
201.10.1.2.102.3 †
201.10.1.2.103.2.1 a) b) c) d) a) b) c) d)
201.10.1.2.103.2.2 c) a) 1), a) 2), b) a) b) c)
201.10.1.2.103.3 †
201.10.1.2.103.4 †
201.10.1.2.103.5 † ← grade A o r grade C test→ † †
201.10.1.2.104.1 a) b) a) b)
201.10.1.2.104.2 †
201.10.1.2.104.3 b) a)
201.10.1.2.104.4 † †
201.10.1.2.104.5 †
201.14.101 † †
201.101.1 †
201.101.2 †
201.101.3 †
201.101.5 †
NOTE † denotes requirement of subclause having no other SPECIFIC identification.
– 20 – 60601-2-1 © IEC:2009
...
IEC 60601-2-1 ®
Edition 3.1 2014-07
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
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IEC 60601-2-1 ®
Edition 3.1 2014-07
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-1771-9
IEC 60601-2-1 ®
Edition 3.1 2014-07
REDLINE VERSION
VERSION REDLINE
colour
inside
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
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
– 2 – IEC 60601-2-1:2009
+AMD1:2014 CSV IEC 2014
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 14
201.5 General requirements for testing 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 . 21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 47
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 47
201.13 HAZARDOUS SITUATIONS and fault conditions . 48
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 48
201.15 Construction of ME EQUIPMENT . 49
201.16 ME SYSTEMS . 49
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 49
206 Usability . 50
Annexes . 60
Annex B (informative) Sequence of testing . 60
Annex I (informative) ME SYSTEMS aspects . 60
Bibliography . 61
Index of defined terms . 62
Figure 201.101 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION
(201.10.1.2.102.1) . 52
Figure 201.102 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION
(201.10.1.2.102.2) . 53
Figure 201.103 – Elevation view – Application of LEAKAGE RADIATION requirements
(201.10.1.2.103 and 201.10.1.2.104) . 54
Figure 201.104 – 24 measurement points for averaging LEAKAGE RADIATION during X-
RADIATION (201.10.1.2.103.2.1) . 55
Figure 201.105 – Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during
ELECTRON IRRADIATION (201.10.1.2.103.2.2) . 56
Figure 201.106 – Measurement points for averaging LEAKAGE RADIATION during
ELECTRON IRRADIATION (201.10.1.2.103.2.2) . 57
Figure 201.107 – 24 measurement points for averaging LEAKAGE RADIATION outside
area M (201.10.1.2.103.3). 58
Figure 201.108 – ME EQUIPMENT movements and scales . 59
+AMD1:2014 CSV IEC 2014
Table 201.101 – Colours of indicator lights and their meaning for ME EQUIPMENT . 16
Table 201.102 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 18
Table 201.103 – Clauses and subclauses in this particular standard that require the
provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and
the technical description . 20
Table 201.104 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION (see
Figure 201.101) . 40
Table 201.105 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see
Figure 201.102) . 40
– 4 – IEC 60601-2-1:2009
+AMD1:2014 CSV IEC 2014
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD
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This Consolidated version of IEC 60601-2-1 bears the edition number 3.1. It consists of
the third edition (2009-10) [documents 62C/474/FDIS and 62C/480/RVD] and its
amendment 1 (2014-07) [documents 62C/532/CDV and 62C/562/RVC]. The technical
content is identical to the base edition and its amendment.
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions and deletions are displayed in red, with
deletions being struck through. A separate Final version with all changes accepted is
available in this publication.
This publication has been prepared for user convenience.
+AMD1:2014 CSV IEC 2014
International Standard IEC 60601-2-1 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 addresses the following issues not covered in previous editions:
– alignment with the new relevant collateral standards;
– new technologies in radiotherapy, including:
• stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT);
• intensity modulated radiotherapy (IMRT);
• electronic imaging devices (e.g. EPID);
• moving beam radiotherapy (dynamic therapy).
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this 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.
– 6 – IEC 60601-2-1:2009
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The committee has decided that the contents of the base publication and its amendment 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 publication using a colour printer.
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INTRODUCTION
The use of ELECTRON ACCELERATORS 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 and/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 ELECTRON ACCELERATORS 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
in order to insure ESSENTIAL PERFORMANCE is maintained to avoid an unsafe
IRRADIATION
condition. TYPE TESTS that are performed by the MANUFACTURER, and/or SITE TESTS, which are
not necessarily performed by the MANUFACTURER, are SPECIFIED for each requirement. It is
understood that SITE TESTS may or may not be required of the MANUFACTURER, per the
agreement between the MANUFACTURER and end user.
Given that before installation a MANUFACTURER cannot provide SITE TEST data, data available
SITE TESTS should be incorporated in the ACCOMPANYING DOCUMENTS, in the form of a SITE
from
TEST report, by those who test the ME EQUIPMENT at installation.
This International Standard was first published in 1981. It was amended in 1984 and 1990. A
second edition was published in 1998 and amended in 2002. This third edition is prompted by
the need to align this particular standard with the third edition of the general standard,
IEC 60601-1:2005.
IEC 60976 and IEC/TR 60977 are closely related to this standard. The former specifies test
methods and reporting formats for performance tests of ELECTRON ACCELERATORS for use in
RADIOTHERAPY, with the aim of providing uniform methods for conducting such tests. The latter
is not a standard per se, but suggests performance values, measured per the methods
specified in IEC 60976, that could be achievable with present technology.
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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
201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to
PATIENTS.
50 MeV, used for treatment of
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively
to the manufacture and some installation aspects of ELECTRON ACCELERATORS
– 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, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-
RADIATION and/or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
–1 –1
• maximum ABSORBED DOSE RATES between 0,001 Gy × s and 1 Gy × s at 1 m from
the RADIATION SOURCE,
• NORMAL TREATMENT DISTANCES (NTDs) between 0,5 m and 2 m from the RADIATION
SOURCE,
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, e.g. STATIONARY RADIOTHERAPY or MOVING
BEAM RADIOTHERAPY,
• 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.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
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IEC 61271 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).
IEC 60676 specifies methods of testing and disclosure of functional performance of medical
ELECTRON ACCELERATORS. The standard is intended to facilitate comparisons of accelerator-
based ME EQUIPMENTs of different manufacture. IEC 60676 contains no safety requirements,
and is therefore not required for compliance with this particular standard. It should also be
noted (as stated in the Introduction to IEC 60976:2007) that tests specified in IEC 60976 are
not necessarily appropriate for ensuring that any individual medical ELECTRON ACCELERATOR
conforms to the declared functional performance during the course of its working lifetime.
NOTE 3 IEC/TR 60977, Medical electrical equipment – Medical electron accelerators – Guidelines for functional
performance characteristics, is a related technical report that provides performance guidelines. It shall not be
construed as a standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ELECTRON ACCELERATORS in the range 1 MeV to 50 MeV 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, NOMINAL ENERGY, and ABSORBED DOSE,
• delivers the RADIATION in accordance with the pre-selected relationship of the RADIATION BEAM to the PATIENT,
by utilizing STATIONARY RADIOTHERAPY, MOVING BEAM RADIOTHERAPY, RADIATION 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 apply as modified in Clauses 206. IEC 60601-1-3, IEC 60601-1-8 and 60601-
do not apply. All other published collateral standards in the IEC 60601-1 series apply as
1-10
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
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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 sections, 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 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3
collateral standard, etc.). The changes to the text of the general standard are specified by the
use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
NOTE Informative references are listed in the bibliography on page 60.
Addition:
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms (available in
English only)
IEC 61217:1996, Radiotherapy equipment – Coordinates, movements and scales
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201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, and
IEC/TR 60788:2004 apply, except as follows:
NOTE An index of defined terms is to be found at the end of the document.
Addition:
201.3.201
AMBIENT DOSE EQUIVALENT
H*(10)
DOSE EQUIVALENT at the point of interest in the actual RADIATION FIELD defined as DOSE
EQUIVALENT which would be generated in the associated oriented and expanded RADIATION
FIELD at a depth of 10 mm on the radius of the ICRU sphere which is oriented opposite to the
direction of incident RADIATION
NOTE 1 An oriented and expanded RADIATION FIELD is an idealized RADIATION FIELD which is expanded and in
which the radiation is additionally oriented in one direction.
NOTE 2 See also ICRU definition of AMBIENT DOSE EQUIVALENT in ICRU Report 39.
201.3.202
CONTROLLING TIMER
device to measure the time during which IRRADIATION occurs and, if a predetermined time is
reached, TO TERMINATE IRRADIATION
201.3.203
ELECTRON BEAM APPLICATOR
BEAM LIMITING DEVICE for ELECTRON RADIATION beams
201.3.204
ELECTRONIC IMAGING DEVICE
EID
device consisting of one or more RADIATION DETECTORS and associated electronics, which
enables anatomical structures of a PATIENT to be viewed as a digital radiograph at a viewing
screen
[IEC 60976:2007, definition 3.5]
201.3.205
ELECTRONIC PORTAL IMAGING DEVICE
EPID
device consisting of a two-dimensional RADIATION DETECTOR and associated electronics,
placed substantially normal to the RADIATION BEAM AXIS, which enables anatomical structures
of a PATIENT to be viewed as a digital radiograph at a viewing screen, using the medical
ELECTRON ACCELERATOR'S RADIATION BEAM as the RADIATION SOURCE
NOTE 1 The primary function of an EPID is in verification of PATIENT set-up, and so replaces the need for port
films for this same purpose.
[IEC 60976:2007, definition 3.6]
NOTE 2 This definition is not included in IEC/TR 60788.
201.3.206
GANTRY
part of the ME EQUIPMENT supporting the RADIATION HEAD
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201.3.207
GEOMETRICAL RADIATION FIELD
geometrical projection of the distal end of the BEAM LIMITING DEVICE on a plane orthogonal to
the REFERENCE AXIS, as seen from the centre of the front surface of the TARGET/ELECTRON
RADIATION window; the GEOMETRICAL RADIATION FIELD may be defined at any distance from the
front surface of the TARGET for X-RADIATION, or from the ELECTRON RADIATION window for
ELECTRON RADIATION
201.3.208
HARD-WIRED
term used where the features of a system can be modified only by physically removing and re-
routing wires
201.3.209
INTENSITY MODULATION RADIATION THERAPY
IMRT
treatment procedure requiring, in general, the coordinated control of photon or electron
fluence, beam orientation relative to the PATIENT, and beam size of the external beam, either
in a continuous or a discrete manner, and as pre-determined by a treatment plan
NOTE The primary purpose of IMRT is to improve the conformity of the dose distribution to the planned TARGET
VOLUME, while minimizing dose to surrounding healthy tissue.
201.3.210
INTERRUPTION OF IRRADIATION/TO INTERRUPT IRRADIATION
stopping of/to stop IRRADIATION and movements with the possibility of continuing without
reselecting operating conditions
201.3.211
MOVING BEAM RADIOTHERAPY
RADIOTHERAPY with any planned displacement of the RADIATION FIELD or PATIENT relative to
each other or with any planned change of ABSORBED DOSE distribution
201.3.212
NOMINAL ENERGY
ENERGY
ENERGY stated by the MANUFACTURER to characterize the RADIATION
BEAM
ENERGY stated by the MANUFACTURER to characterize the radiation BEAM
201.3.213
NORMAL TREATMENT DISTANCE
NTD
SPECIFIED distance measured along the REFERENCE AXIS from the
ELECTRON RADIATION window to the distal end of the ELECTRON BEAM APPLICATOR or to a
SPECIFIED plane
SPECIFIED distance measured along the REFERENCE AXIS from the front surface
of the TARGET to the ISOCENTRE or, for ME EQUIPMENT without an ISOCENTRE, to a SPECIFIED
plane
201.3.214
PASSWORD
sequence of keystrokes that permits OPERATOR access for NORMAL USE or to
reset INTERLOCKS and, with a different sequence of keystrokes, permits access for adjustment
and maintenance
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201.3.215
PATIENT SUPPORT
assembly of ME EQUIPMENT that supports the PATIENT
201.3.216
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
201.3.217
QUALIFIED PERSON
person recognised by a competent authority as having the requisite knowledge and training to
perform particular duties
201.3.218
RADIATION TYPE
nature of the waves or corpuscles comprising the RADIATION
NOTE E.g. whether the RADIATION is X-RADIATION or ELECTRON RADIATION.
201.3.219
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
201.3.220
RELATIVE SURFACE DOSE
ratio of the ABSORBED DOSE on the REFERENCE AXIS, at the depth of 0,5 mm, to the maximum
ABSORBED DOSE on the REFERENCE AXIS, both measured in a PHANTOM with its surface at a
SPECIFIED distance
201.3.221
SITE TEST
after installation, test of an individual device or ME EQUIPMENT to establish compliance with
SPECIFIED criteria
201.3.222
STEREOTACTIC RADIOTHERAPY
SRT
treatment procedure in which RADIATION BEAMS of generally small size are oriented from
TARGET VOLUME within the PATIENT
various angles, and precisely positioned relative to a
NOTE Precise location of the TARGET VOLUME is enabled by use of a three-dimensional frame of reference, which
may include anatomical registration points or markers, and immobilisation methods, or imaging techniques.
201.3.223
STEREOTACTIC RADIOSURGERY
SRS
SPECIFIC version of STEREOTACTIC RADIOTHERAPY, in which a single high dose of RADIATION is
delivered to the TARGET VOLUME, using a STEREOTACTIC FRAME OF REFERENCE in conjunction
with anatomical registration points
201.3.224
STEREOTACTIC FRAME OF REFERENCE
three-dimensional coordinate system for numerical specification of the position of those parts
of a PATIENT anatomy intended for SRS/SRT treatment
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201.3.225
TERMINATION OF IRRADIATION
TERMINATE IRRADIATION
stopping of/to stop IRRADIATION and movements, with no possibility of restarting without the
reselection of all operating conditions
NOTE 1 I.e. returning/to return to the PREPARATORY STATE.
NOTE 2 Events that TERMINATE IRRADIATION and stop movements include the following:
• when the pre-selected value of DOSE MONITOR UNITS is reached,
• when the pre-selected value of elapsed time is reached,
• a deliberate manual act,
• the operation of an INTERLOCK,
• in MOVING BEAM RADIOTHERAPY, when the pre-selected value of an angular or linear dimension is exceeded.
201.3.226
TRANSMISSION DETECTOR
RADIATION DETECTOR through which the RADIATION BEAM passes
201.3.227
TYPE TEST
ME EQUIPMENT test by the MANUFACTURER to establish compliance with SPECIFIED criteria for a
particular design of device or ME EQUIPMENT
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
Requirements of 201.10 are identified as ESSENTIAL PERFORMANCE requirements.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.1 TYPE TESTS
Additional subclause:
201.5.1.101 Test grades
Three grades of TYPE TEST and two of SITE TEST procedures are SPECIFIED in 201.10 of 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,
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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.
201.5.4 Other conditions
Item 5.4 a) of the general standard does not apply.
Replacement of item 5.4 d):
d) Where cooling water is required, water as required in the technical description is used.
Addition:
The MANUFACTURER manufacturer shall state in the ACCOMPANYING DOCUMENTS any additional
requirement 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:
201.7.2.4 ACCESSORIES
Addition:
The dimensions of the GEOMETRICAL RADIATION FIELD at NTD and the distance from the distal
end to NTD shall be clearly legible on the outside of all interchangeable and non-adjustable
BEAM LIMITING DEVICES (BLDs) and ELECTRON BEAM APPLICATORS.
Each manually interchangeable WEDGE FILTER shall be clearly marked to establish its identity.
201.7.2.20 Removable protective means
Addition:
Where the requirements of the subclause of the general standard are wholly or partly met by
the nature of the installation, compliance at installation should be checked by inspection; the
results should be included in the SITE TEST report.
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201.7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclause:
201.7.3.101 RADIATION HEAD
Removal of the covers of the RADIATION HEAD shall expose symbol 11 safety sign 10 of
Table D.1 2 of the general standard, indicating "Attention, consult ACCOMPANYING DOCUMENTS
Follow instructions for use".
201.7.4 Marking of controls and instruments
Additional subclause:
201.7.4.101 Provision of scales and indications for moving parts
The following shall be provided:
a) a mechanical scale or a numerical indication for each available movement;
b) a means to align the PATIENT with respect to the REFERENCE AXIS (e.g. LIGHT FIELD, lasers
etc.);
c) a means to determine RADIATION SOURCE TO SKIN DISTANCE (e.g. scale, numerical
indication, or lasers).
The designation, direction of increasing value and zero position of all movements shall comply
with IEC 61217 (see Figure 201.108).
Compliance is checked by inspection.
201.7.8 Indica
...
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