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

IEC 60601-2-17:2013 applies to the basic safety and essential performance of automatically-controlled Brachytherapy Afterloading Medical Equipment. This standard does not specify requirements for sealed radioactive sources. 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.

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: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.60 - Therapy equipment
• ICS: 19.100 - Non-destructive testing
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-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
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: 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

Relations

• Replaces: EN 60601-2-17:2004 - Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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).
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.
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
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-17 ®
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

– 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

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 nat
...