SIST EN 60601-2-17:2015

Medical electrical equipment - Part 2-17: Particular requirements for basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard applies to automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT used for treatment or alleviation of disease.
This standard specifies requirements
a) for automatically-controlled AFTERLOADING ME EQUIPMENT
1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with automatically-controlled AFTERLOADING ME EQUIPMENT,
2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT, to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the reference location,
3) which is designed for connection to a PATIENT, and
4) with which movements of the RADIATION SOURCE(S) are carried out automatically by the ME EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems and
b) for ME EQUIPMENT intended to be 1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY;
2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR USE;
3) subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
This standard does not specify requirements for SEALED RADIOACTIVE SOURCES. Requirements
for the design of X-RAY TUBES used with the ME EQUIPMENT are specified in other IEC standards. See for example: IEC 60601-2-28:2010.
The requirements of this standard are based on the assumptions that:
– a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT PARAMETERS, and
– the SOURCE STRENGTH(S) or the REFERENCE AIR-KERMA RATE of the RADIATION SOURCE(S)
used by the ME EQUIPMENT is (are) known.
This standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the ME EQUIPMENT, in particular that:
– the selected RADIATION SOURCE(S) is (are) positioned or moved within the SOURCE APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
– IRRADIATION is performed by the selected RADIATION SOURCE configuration for the selected duration;
– IRRADIATION is performed by the ME EQUIPMENT without causing unnecessary RISK to the OPERATOR or other persons in the immediate surroundings.

Medizinische elektrische Geräte - Teil 2-17: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von ferngesteuerten, automatisch betriebenen Afterloading-Geräten für die Brachytherapie

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

L'IEC 60601-2-17:2013 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux de projection de sources radioactives a chargement différé automatique utilisés en Brachythérapie. La présente norme ne précise pas les exigences relatives aux sources radioactives scellées. Cette troisième édition annule et remplace la deuxième édition publiée en 2004. Ont été pris en considération les nouvelles normes CEI, les amendements aux normes CEI existantes, les développements des technologies et des utilisations médicales, ainsi que les différents dangers qui ont été rencontrés et envisagés depuis la préparation de la première édition et de la deuxième édition. Cette édition constitue une révision technique qui aligne cette norme avec la CEI 60601-1:2005+A1:2012 et ses normes collatérales.

Medicinska električna oprema - 2-17. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za brahiterapijo z avtomatičnim krmiljenjem naknadnega polnjenja

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTROMEDICINSKE OPREME ZA BRAHITERAPIJO Z AVTOMATIČNIM KRMILJENJEM NAKNADNEGA POLNJENJA, v nadaljevanju: ELEKTROMEDICINSKA OPREMA.
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. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
OPOMBA: Glej tudi točko 4.2 splošnega standarda.
Ta standard velja za ELEKTROMEDICINSKO OPREMO ZA BRAHITERAPIJO Z AVTOMATIČNIM KRMILJENJEM NAKNADNEGA POLNJENJA, ki se uporablja za zdravljenje ali lajšanje bolezni.
Ta standard določa zahteve
a) za ELEKTROMEDICINSKO OPREMO ZA BRAHITERAPIJO Z AVTOMATIČNIM KRMILJENJEM NAKNADNEGA POLNJENJA
1) ki vsebuje in uporablja izključno ZAPRTE RADIOAKTIVNE VIRE, ki oddajajo beta ali gama delce ali NEVTRONE, ali VIRE Z RENTGENSKIMI ŽARKI ZA BRAHITERAPIJO, osnovane in izdelane za uporabo z ELEKTROMEDICINSKO OPREMO Z AVTOMATIČNIM KRMILJENJEM NAKNADNEGA POLNJENJA,
2) ki samodejno premakne RADIOAKTIVNE VIRE iz VSEBINKA ZA SHRANJEVANJE ali, v primeru RENTGENSKIH VIROV ZA BRAHITERAPIJO, referenčnega mesta zunaj PACIENTA na mesto zdravljenja znotraj NANAŠALNIKOV VIRA in vrne RADIOAKTIVNE VIRE v VSEBNIK ZA SHRANJEVANJE ali RENGTGENSKE VIRE ZA BRAHITERAPIJO na referenčno mesto,
3) ki je zasnovano za priključitev na PACIENTA in
4) pri kateri premike RADIOAKTIVNIH VIROV izvede ELEKTROMEDICINSKA OPREMA samodejno v skladu s predpisanim programom in z uporabo mehanizma, čigar spremembe krmilijo KRMILNI ČASOMERI in NAPRAVE ZA MERJENJE ČASA, ki so PROGRAMIRLJIVI ELEKTRONSKI PODSISTEMI (PESS) (računalniki ali mikroprocesorji) ali neprogramirljivi sistemi in
b) za ELEKTROMEDICINSO OPREMO, ki je namenjena 1) NORMALNI UPORABI, pri čemer jih pod vodstvom ustrezno licenciranih ali KVALIFICIRANIH OSEB upravljajo OPERATERJI z zahtevanimi veščinami za določeno medicinsko uporabo, za določene opredeljene klinične namene, npr. BRAHITERAPIJA Z NAKNADNIM POLNJENJEM;
2) se vzdržuje v skladu s priporočili, podanimi v NAVODILIH ZA UPORABO;
3) je predmet rednih pregledov zagotavljanja kakovosti, delovanja in umerjanja, ki jih izvaja KVALIFICIRANA OSEBA.
Ta standard ne navaja zahtev za ZAPRTE RADIOAKTIVNE VIRE. Zahteve
za projektiranje RENTGENSKIH CEVI, ki se uporabljajo z ELEKTROMEDICINSKO OPREMO, so navedene v drugih standardih IEC. Glejte na primer: IEC 60601-2-28:2010.
Zahteve tega standarda so osnovane na predpostavkah, da:
– je na voljo NAČRT ZDRAVLJENJA, ki predpisuje primerne vrednosti PARAMETROV ZDRAVLJENJA in
– je MOČ VIROV ali REFERENČNA STOPNJA KERME V ZRAKU RADIOAKTIVNIH VIROV,
ki jih ELEKTROMEDICINSKA OPREMA uporablja, znano.
Ta standard vključuje zahteve, ki zagotavljajo, da ELEKTROMEDICINSKA OPREMA lahko doseže predpisane vrednosti PARAMETROV ZDRAVLJENJA, predvsem, da:
– so izbrani RADIOAKTIVNI VIRI postavljeni ali premaknjeni znotraj NANAŠALNIKA VIRA v izbrani konfiguraciji, odvisno od NANAŠALNIKA VIRA;
– OBSEVANJE opravi izbrana konfiguracija RADIOAKTIVNEGA VIRA za izbrano trajanje;
– OBSEVANJE opravi ELEKTROMEDICINSKA OPREMA, ne da bi povzročila nepotrebno TVEGANJE za OPERATERJA ali druge osebe v neposredni bližini.

General Information

• Status: Published
• Publication Date: 16-Aug-2015
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 17-Aug-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-17:2015 - Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment

Relations

• Replaces: SIST EN 60601-2-17:2004 - Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)
• Effective Date: 28-Jan-2023
• Replaces: SIST EN 60601-2-17:2004 - Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)
• Effective Date: 01-Sep-2015
• Replaces: SIST EN 60601-2-17:2004 - Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-17:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-17:2004
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DEUDKLWHUDSLMR]DYWRPDWLþQLPNUPLOMHQMHP
QDNQDGQHJDSROQMHQMD
Medical electrical equipment - Part 2-17: Particular requirements for basic safety and
essential performance of automatically-controlled brachytherapy afterloading equipment
Medizinische elektrische Geräte - Teil 2-17: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von ferngesteuerten, automatisch
betriebenen Afterloading-Geräten für die Brachytherapie
Appareils électromédicaux - Partie 2-17: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils projecteurs de sources radioactives à
chargement différé automatique utilisés en brachythérapie
Ta slovenski standard je istoveten z: EN 60601-2-17:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-17:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-17:2015

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SIST EN 60601-2-17:2015


EUROPEAN STANDARD EN 60601-2-17

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.60 Supersedes EN 60601-2-17:2004
English Version
Medical electrical equipment - Part 2-17: Particular requirements
for the basic safety and essential performance of automatically-
controlled brachytherapy afterloading equipment
(IEC 60601-2-17:2013)
Appareils électromédicaux - Partie 2-17: Exigences Medizinische elektrische Geräte - Teil 2-17: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils projecteurs de sources wesentlichen Leistungsmerkmale von ferngesteuerten,
radioactives à chargement différé automatique utilisés en automatisch betriebenen Afterloading-Geräten für die
brachythérapie Brachytherapie
(IEC 60601-2-17:2013) (IEC 60601-2-17:2013)
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 60601-2-17:2015 E

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SIST EN 60601-2-17:2015
EN 60601-2-17:2015
Foreword
The text of document 62C/575/FDIS, future edition 3 of IEC 60601-2-17, prepared by SC 62C
"Equipment for radiotherapy, nuclear medicine and radiation dosimetry", of IEC/TC 62 "Electrical
equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-2-17:2015.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-01-14
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-17:2004.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-17:2013 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-2-28:2010 NOTE Harmonized as EN 60601-2-28:2010 (not modified).
IEC 61217:2011 NOTE Harmonized as EN 61217:2012 (not modified).
2

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SIST EN 60601-2-17:2015
EN 60601-2-17:2015
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, except as follows:
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:2006:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance
+ A1 2012 + A1 2013
- -  + A1/AC 2014
- -  + A12 2014
IEC 60601-2-1 2009 Medical electrical equipment - - -
Part 2-1: Particular requirements for the
basic safety and essential performance of
electron accelerators in the range 1 MeV to
50 MeV
1)
IEC 60601-2-8 2010 Medical electrical equipment - EN 60601-2-8
Part 2-8: Particular requirements for the
basic safety and essential performance of
therapeutic X-ray equipment operating in
the range 10 kV to 1 MV
IEC 60601-2-11 2013 Medical electrical equipment - EN 60601-2-11 2015
Part 2-11: Particular requirements for the
basic safety and essential performance of
gamma beam therapy equipment
IEC 61005 (mod) 2003 Radiation protection instrumentation - EN 61005 2004
Neutron ambient dose equivalent (rate)
meters

1) To be published.
3

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SIST EN 60601-2-17:2015
EN 60601-2-17:2015
Publication Year Title EN/HD Year
IEC 62083 2009 Medical electrical equipment - EN 62083 2009
Requirements for the safety of
radiotherapy treatment planning systems
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms

4

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SIST EN 60601-2-17:2015
EN 60601-2-17:2015
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
5

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SIST EN 60601-2-17:2015

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SIST EN 60601-2-17:2015



IEC 60601-2-17

®


Edition 3.0 2013-11




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Medical electrical equipment –

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

performance of automatically-controlled brachytherapy afterloading equipment




Appareils électromédicaux –

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


performances essentielles des appareils projecteurs de sources radioactives à

chargement différé automatique utilisés en brachythérapie












INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX X


ICS 11.040.60 ISBN 978-2-8322-1214-1



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-17:2015
– 2 – 60601-2-17  IEC:2013
CONTENTS

FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 37
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 37
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 40
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 40
201.15 Construction of ME EQUIPMENT . 40
201.16 ME SYSTEMS . 40
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 40
Annex A (informative) General guidance and rationale . 41
Bibliography . 42
Index of defined terms used in this particular standard . 43

Table 201.101 – Colours of lights and their meanings . 14

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SIST EN 60601-2-17:2015
60601-2-17  IEC:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy
afterloading equipment


FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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 60601-2-17 has been prepared by IEC subcommittee 62C:
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical
committee 62: Electrical equipment in medical practice.
This third edition cancels and replaces the second edition, published in 2004. Consideration
has been given to new IEC standards, amendments to existing IEC standards, developments
in technology and clinical usage, and various hazards encountered and envisaged since the
preparation of the first and second editions. This edition constitutes a technical revision which
brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.

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SIST EN 60601-2-17:2015
– 4 – 60601-2-17  IEC:2013
The text of this particular standard is based on the following documents:
FDIS Report on voting
62C/575/FDIS 62C/579/RVD

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
–
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 201.7 includes subclauses 201.7.1, 201.7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and
201.7.2.1 are all subclauses of Clause 201.7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
A list of all parts of the IEC 60601 series, published under the general title MEDICAL ELECTRICAL
EQUIPMENT, can be found on the IEC website.

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SIST EN 60601-2-17:2015
60601-2-17  IEC:2013 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN 60601-2-17:2015
– 6 – 60601-2-17  IEC:2013
INTRODUCTION
The delivery of RADIOTHERAPY over short distances is called BRACHYTHERAPY. BRACHYTHERAPY
is delivered by positioning RADIATION SOURCES within or adjacent to the tissue to be treated.
Historically, RADIOACTIVE SOURCES were handled manually, resulting in IRRADIATION of the
OPERATOR’S hands. AFTERLOADING generally refers to the technique of placing an applicator
into or adjacent to the tissue to be treated, and introducing one or more RADIATION SOURCE(S)
only after the applicator position has been confirmed. This procedure minimizes the time
during which the operator is exposed to the RADIATION SOURCE(S). Manual AFTERLOADING
techniques were developed in the 1950s and are used routinely today for permanent implants,
but less frequently for temporary implants.
Temporary implants require the use of higher dose rates, to ensure that the treatment can be
completed in a length of time easily tolerated by the PATIENT. In the 1980s, automatic remote
AFTERLOADING techniques were developed, that could move a RADIOACTIVE SOURCE or SOURCES
through connecting tubes from a shielded safe to the applicators implanted in the patient.
Because the SOURCE(S) could be moved remotely, the risk of exposure to personnel could be
eliminated.
In 2007 an automatic remote afterloader was introduced that replaced the conventional
RADIOACTIVE SOURCE(S) with an X-ray source. This device otherwise performed similarly to
AFTERLOADERS containing RADIOACTIVE SOURCES. However, the X-ray source could be disabled
when not in use, removing any risk of IRRADIATION. BRACHYTHERAPY devices that employ X-ray
source(s) are subject to the requirements of IEC 60601-2-8, in addition to those of this
standard.
The use of AFTERLOADING ME EQUIPMENT for BRACHYTHERAPY purposes may expose PATIENTS to
danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME
EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The ME
EQUIPMENT may also cause danger to persons in the vicinity if the ME EQUIPMENT itself fails to
contain the RADIOACTIVE SOURCE(S) adequately within the STORAGE CONTAINER(S), if the X-RAY
TUBE is energized inappropriately, or if there are inadequacies in the design of the TREATMENT
ROOM.
This particular standard establishes requirements to be complied with by MANUFACTURERS in
the design and construction of AFTERLOADING ME EQUIPMENT for use in temporary
BRACHYTHERAPY procedures; it does not attempt to define their optimum performance
requirements. Its purpose is to identify those features of design that are regarded, at the
present time, as essential for the safe operation of such ME EQUIPMENT. It places limits on the
degradation of ME EQUIPMENT performance beyond which it can be presumed that a fault
condition exists and at which an INTERLOCK then operates to disable the X-RAY TUBE(S) or
return the RADIOACTIVE SOURCE(S) to the STORAGE CONTAINER(S) and afterwards to prevent
continued operation of the ME EQUIPMENT.

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SIST EN 60601-2-17:2015
60601-2-17  IEC:2013 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy
afterloading equipment



201.1 Scope, object and related standards
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
automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as
ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard applies to automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT
used for treatment or alleviation of disease.
This standard specifies requirements
a) for automatically-controlled AFTERLOADING ME EQUIPMENT
1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE
SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with
automatically-controlled AFTERLOADING ME EQUIPMENT,
2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in
the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT,
to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION
SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the
reference location,
3) which is designed for connection to a PATIENT, and
4) with which movements of the RADIATION SOURCE(S) are carried out automatically by
the ME EQUIPMENT according to a prescribed programme using a powered mechanism
whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that
are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or
microprocessors) or non-programmable systems and
b) for ME EQUIPMENT intended to be
—————————
1
The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance

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SIST EN 60601-2-17:2015
– 8 – 60601-2-17  IEC:2013
1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED
PERSONS by OPERATORS having the required skills for a particular medical application,
for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY;
2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR
USE;
3) subject to regular quality assurance performance and calibration checks by a
QUALIFIED PERSON.
This standard does not specify requirements for SEALED RADIOACTIVE SOURCES. Requirements
for the design of X-RAY TUBES used with the ME EQUIPMENT are specified in other IEC
standards. See for example: IEC 60601-2-28:2010.
The requirements of this standard are based on the assumptions that:
– a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT
PARAMETERS, and
– the SOURCE STRENGTH(S) or the REFERENCE AIR-KERMA RATE of the RADIATION SOURCE(S)
used by the ME EQUIPMENT is (are) known.
This standard includes requirements intended to ensure that the prescribed values of the
TREATMENT PARAMETERS can be achieved by the ME EQUIPMENT, in particular that:
– the selected RADIATION SOURCE(S) is (are) positioned or moved within the SOURCE
APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
– IRRADIATION is performed by the selected RADIATION SOURCE configuration for the selected
duration;
– IRRADIATION is performed by the ME EQUIPMENT without causing unnecessary RISK to the
OPERATOR or other persons in the immediate surroundings.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for automatically-controlled BRACHYTHERAPY AFTERLOADING
ME EQUIPMENT.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this standard.
2
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
—————————
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 60601-2-17:2015
60601-2-17  IEC:2013 – 9 –
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005+A1:2012, is referred to in this particular standard as the
general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbe
...