SIST EN 60601-2-8:2015
Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
This international standard applies to the basic safety and essential performance of therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kV to 1 MV when connected to alternating current SUPPLY MAINS, hereafter referred to as ME EQUIPMENT.
NOTE This standard covers TELETHERAPY and BRACHYTHERAPY.
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.
Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV
Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV
La CEI 60601-2-8:2010 établit des exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant à des hautes tensions radiogènes nominales comprises entre 10 kV et 1 MV quand ils sont reliés à un réseau d'alimentation fournissant du courant alternatif. Elle établit des exigences pour la précision et à la reproductibilité des caractéristiques dans la mesure où celles-ci sont en relation avec la qualité de rayonnement et les grandeurs liées au rayonnement ionisant émis et où elles doivent donc être considérées comme des aspects de la sécurité. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-8. Cette édition constitue une révision technique qui aligne la présente norme sur la troisième édition de la CEI 60601-1 et ses normes collatérales.
Medicinska električna oprema - 2-8. del: Posebne zahteve za osnovno varnost in bistvene lastnosti terapevtske rentgenske opreme, ki deluje v območju od 10 kV do 1 MV
Ta mednarodni standard se nanaša na osnovno varnost in bistvene lastnosti terapevtske RENTGENSKE OPREME z NAZIVNO NAPETOSTJO RENTGENSKE CEVI v razponu od 10 kV do 1 MV, ko je priključena na NAPAJALNO OMREŽJE z izmeničnim tokom, v nadaljevanju: MEDICINSKA ELEKTRIČNA (ME) OPREMA.
OPOMBA: Ta standard obravnava TELERADIOTERAPIJO IN BRAHITERAPIJO.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-8:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-8:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLWHUDSHYWVNHUHQWJHQVNHRSUHPHNLGHOXMHYREPRþMXRGN9
GR09
Medical electrical equipment - Part 2-8: Particular requirements for basic safety and
essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1
MV
Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen
im Bereich von 10 kV bis 1 MV
Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de thérapie
fonctionnant dans la gamme de 10 kV à 1 MV
Ta slovenski standard je istoveten z: EN 60601-2-8:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-8:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-8:2015
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SIST EN 60601-2-8:2015
EUROPEAN STANDARD EN 60601-2-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.50 Supersedes EN 60601-2-8:1997
English Version
Medical electrical equipment - Part 2-8: Particular requirements
for the basic safety and essential performance of therapeutic X-
ray equipment operating in the range 10 kV to 1 MV
(IEC 60601-2-8:2010)
Appareils électromédicaux - Partie 2-8: Exigences Medizinische elektrische Geräte - Teil 2-8: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements à rayonnement X de thérapie wesentlichen Leistungsmerkmale von Therapie-
fonctionnant dans la gamme de 10 kV à 1 MV Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV
(IEC 60601-2-8:2010) (IEC 60601-2-8:2010)
This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-8:2015 E
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SIST EN 60601-2-8:2015
EN 60601-2-8:2015 (E)
Foreword
The text of document 62C/499/FDIS, future edition 2 of IEC 60601-2-8, prepared by SC 62C, "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry", of IEC TC 62, "Electrical equipment in
medical practice", was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
EN 60601-2-8:2015.
The following dates are fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2016-01-14
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2018-04-14
This document supersedes EN 60601-2-8:1997.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this
document.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-8:2010 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-2-17 NOTE Harmonized as EN 60601-2-17.
__________
2
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SIST EN 60601-2-8:2015
EN 60601-2-8:2015 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Addition:
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
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 61217 - Radiotherapy equipment - Coordinates, EN 61217 -
movements and scales
ISO/IEC Guide 98-3 2008 Uncertainty of measurement - - -
Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)
3
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SIST EN 60601-2-8:2015
EN 60601-2-8:2015 (E)
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning
medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
NOTE Presumption of conformity with Essential Requirements 13.1 to 13.6 should depend on the
manufacturer confirming the accuracy of the accompanying documents in all relevant languages.
WARNING: Other requirements and other EU Directives can be applied to the products falling within the
scope of this standard.
4
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SIST EN 60601-2-8:2015
IEC 60601-2-8
®
Edition 2.0 2010-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-8: Particular requirements for the basic safety and essential performance
of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
Appareils électromédicaux –
Partie 2-8: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de thérapie fonctionnant dans la
gamme de 10 kV à 1 MV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.50 ISBN 978-2-88912-238-7
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN 60601-2-8:2015
– 2 – 60601-2-8 Ó IEC:2010
CONTENTS
FOREW ORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 30
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 30
201.13 HAZARDOUS SITUATIONS and fault conditions . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS ) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 ME SYSTEMS . 31
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
Bibliography . 32
Index of defined terms used in this particular standard . 33
Table 201.101 – Data required in the technical description to support Clause 201.10
SITE and TYPE TEST compliance . 10
Table 201.102 – Permissible LEAKAGE RADIATION . 16
Table 201.103 – Permissible LEAKAGE RADIATION from X-RAY TUBE ASSEMBLIES with
BEAM LIMITING DEVICES . 18
Table 201.104 – Overview of measurements . 29
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SIST EN 60601-2-8:2015
60601-2-8 Ó IEC:2010 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-8: Particular requirements for the basic safety and essential
performance of therapeutic X-ray equipment operating
in the range 10 kV to 1 MV
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 60601-2-8 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 second edition cancels and replaces the first edition of IEC 60601-2-8. This edition
constitutes a technical revision which brings this standard in line with the third edition of
IEC 60601-1 and its collateral standards.
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SIST EN 60601-2-8:2015
– 4 – 60601-2-8 Ó IEC:2010
The text of this particular standard is based on the following documents:
FDIS Report on voting
62C/499/FDIS 62C/505/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.
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.
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SIST EN 60601-2-8:2015
60601-2-8 Ó IEC:2010 – 5 –
INTRODUCTION
X-RAY EQUIPMENT for RADIOTHERAPY purposes is used for TELETHERAPY, where the RADIATION
SOURCE is far from the tissues to the treated (usually more than 50 cm), and also for
BRACHYTHERAPY, where the RADIATION SOURCE is positioned within or adjacent to the tissue to
be treated. This particular standard covers X-RAY EQUIPMENT for both TELETHERAPY and
BRACHYTHERAPY.
The use of X-RAY EQUIPMENT for RADIOTHERAPY purposes may expose the PATIENT to danger if
the equipment fails to deliver the required dose to the PATIENT, or if the equipment design
does not satisfy standards of electrical and mechanical safety. The equipment may also cause
danger to persons in the vicinity if the 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 the MANUFACTURERS
in the design and construction of therapeutic X-RAY EQUIPMENT. Subclause 201.10.1 contains
limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE IRRADIATION in order to
avoid an unsafe condition.
Subclause 201.10.1 does not attempt to define 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 equipment. It places limits on the degradation of
equipment performance beyond which it can be presumed that a fault condition exists, e.g. a
component failure, and where an INTERLOCK then operates to prevent continued operation of
the equipment.
It should be understood that, before installation, a MANUFACTURER can provide a compliance
certificate relating only to TYPE TESTS: data available from SITE TESTS should be incorporated
in the ACCOMPANYING DOCUMENTS, in the form of a SITE TEST report, by those who test the
equipment at installation.
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SIST EN 60601-2-8:2015
– 6 – 60601-2-8 Ó IEC:2010
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-8: Particular requirements for the basic safety and essential
performance of therapeutic X-ray equipment operating
in the range 10 kV to 1 MV
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
therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kV to 1 MV
when connected to alternating current SUPPLY MAINS, hereafter referred to as ME EQUIPMENT.
NOTE This standard covers TELETHERAPY and BRACHYTHERAPY.
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.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular basic safety and essential
performance requirements for therapeutic X-RAY EQUIPMENT. It includes the requirements for
accuracy and reproducibility of performance to the extent that these are related to radiation
quality and the quantity of ionizing radiation produced and thus must be considered as
aspects of safety.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
2)
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
2)
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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SIST EN 60601-2-8:2015
60601-2-8 Ó IEC:2010 – 7 –
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other basic safety and essential
performance requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
SPECIFIED by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Addition:
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
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
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SIST EN 60601-2-8:2015
– 8 – 60601-2-8 Ó IEC:2010
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales
ISO/IEC Guide 98-3:2008, Uncertainty of measurement – Part 3: Guide to the expression of
uncertainty in measurement (GUM:1995)
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC TR 60788:2004 apply, except as follows.
NOTE An index of defined terms is found beginning on page 33.
Addition:
201.3.201
BRACHYTHERAPY
RADIOTHERAPY using one or more RADIATION SOURCES with the RADIATION SOURCE/sources
inside or close to the TARGET VOLUME
NOTE BRACHYTHERAPY techniques include INTERSTITIAL, INTRACAVITARY, SUPERFICIAL or INTRALUMINAL
RADIOTHERAPY.
201.3.202
INTERSTITIAL RADIOTHERAPY
RADIOTHERAPY with RADIATION SOURCES inserted within the TARGET VOLUME
201.2.203
INTRACAVITARY RADIOTHERAPY
RADIOTHERAPY in which one or more RADIATION SOURCES, with or without SOURCE APPLICATORS,
are introduced into a body cavity through a natural or artificial opening
201.3.204
INTRALUMINAL RADIOTHERAPY
RADIOTHERAPY in which one or more RADIATION SOURCES, with or without SOURCE APPLICATORS,
are introduced into a body lumen such as a blood vessel, air way, or the gastrointestinal tract
201.3.205
SOURCE APPLICATOR
device to bring one or more RADIATION SOURCES into the intended positions
NOTE A SOURCE APPLICATOR may include protective shielding.
201.3.206
TELERADIOTHERAPY
TELETHERAPY
RADIOTHERAPY with a large RADIATION SOURCE TO SKIN DISTANCE, usually not less than 50 cm
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
Additional subclause:
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SIST EN 60601-2-8:2015
60601-2-8 Ó IEC:2010 – 9 –
201.4.101 Conventional meaning of electrical quantities
In this particular standard, unless otherwise indicated, values of X-RAY TUBE VOLTAGE refer to
peak values.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.1 TYPE TESTS
Addition:
201.5.1.101 Test grades
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,
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 the circuitry or the construction of
the ME EQUIPMENT, the test should be performed by, or under the direct supervision of, the
MANUFACTURER or the MANUFACTURER’S agent.
Table 201.101 summarises the data required in the technical description to support Clause
201.10 SITE TEST compliance.
201.5.4 Other conditions
Addition:
aa) The ACCOMPANYING DOCUMENTS shall include
1) statements resulting from TYPE TESTS: grade A;
2) details of and results from TYPE TESTS: grade B and grade C;
3) SPECIFIC procedures and test conditions for SITE
...
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