EN 60601-2-64:2015

Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of ME equipment intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems, that, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n. Key words: nuclear medicine, radiation dosimetry.

Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-Bestrahlungseinrichtungen

Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers

L'IEC 60601-2-64:2014 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux par Faisceau d'Ions Légers, désignés ci-après par le terme appareils EM, utilisés pour le traitement des patients. La présente norme particulière, y compris les essais de type et les essais sur le site, s'applique respectivement au fabricant et à certains aspects d'installation des appareils EM par Faisceau d'Ions Légers destinés à être utilisés à des fins de radiothérapie dans la médecine humaine, y compris les appareils dont le choix et l'affichage des paramètres de fonctionnement peuvent être contrôlés automatiquement par des sous-systèmes électroniques programmables qui, en utilisation normale, délivrent un faisceau de rayonnement d'ions légers dont l'énergie par nucléon se situe dans la gamme 10 MeV/n à 500 MeV/n. Mots clé: médecine nucléaire, dosimétrie de radiations.

Medicinska električna oprema - 2-64. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinske opreme za lahkoionsko terapijo

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTROMEDICINSKE OPREME ZA LAHKOIONSKO TERAPIJO (v nadaljevanju: ELEKTROMEDICINSKA OPREMA), ki se uporablja za zdravljenje PACIENTOV. 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. Ta standard z vključitvijo TIPSKIH PRESKUSOV in PRESKUSOV NA LOKACIJI se uporablja za proizvodnjo in določene vidike namestitve OPREME ZA LAHKOIONSKO TERAPIJO – namenjeno RADIOTERAPIJI v človeški medicini, vključno s tisto, kjer lahko PROGRAMLJIVI ELEKTRONSKI PODSISTEMI (PESS) samodejno nadzirajo izbiro in PRIKAZ obratovalnih parametrov,
– ki pri OBIČAJNI UPORABI oddaja RADIACIJSKE ŽARKE LAHKIH IONOV z ENERGIJO NA NUKLEON v razponu od 10 MeV/n do 500 MeV/n in
– je namenjena
– OBIČAJNI 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 v skladu s priporočili, podanimi v NAVODILIH ZA UPORABO,
– je predmet rednih pregledov zagotavljanja kakovosti, delovanja in umerjanja, ki jih izvaja KVALIFICIRANA OSEBA.
OPOMBA 1: V tem standardu se vsa sklicevanja na obrat nanašajo na obrat v prostorih ODGOVORNE ORGANIZACIJE.
OPOMBA 2: V tem standardu se ABSORBIRANA DOZA nanaša na ABSORBIRANO DOZO v vodi.
OPOMBA 3: Informacije glede smernic za rentgensko slikanje lahko najdete v standardu IEC 60601-2-68 (v pripravi).
OPOMBA 4: Standard IEC 61217 podaja smernice za označevanje premikov ELEKTROMEDICINSKE OPREME, označevanje tehtnic, njihovih osnovnih pozicij in smeri premikov z višanjem vrednosti (glejte točko 201.7.4.101).

General Information

• Status: Published
• Publication Date: 28-May-2015
• Withdrawal Date: 28-May-2018
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 29-May-2015
• Completion Date: 29-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-64:2015 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical equipment

Relations

• Amended By: EN 60601-2-64:2015/prA1:2024 - Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLPHGLFLQVNHRSUHPH]DODKNRLRQVNRWHUDSLMR
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and
essential performance of light ion beam medical equipment
Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-
Bestrahlungseinrichtungen
Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de thérapie par faisceau ionique lumineux
Ta slovenski standard je istoveten z: EN 60601-2-64:2015
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 60601-2-64

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-64: Particular requirements
for the basic safety and essential performance of light ion beam
medical electrical equipment
(IEC 60601-2-64:2014)
Appareils électromédicaux - Partie 2-64: Exigences Medizinische elektrische Geräte - Teil 2-64: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils électromédicaux par faisceau wesentlichen Leistungsmerkmale von Leichtionen-
d'ions légers Bestrahlungseinrichtungen
(IEC 60601-2-64:2014) (IEC 60601-2-64:2014)
This European Standard was approved by CENELEC on 2014-10-08. 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 60601-2-64:2015 E
Foreword
The text of document 62C/594/FDIS, future edition 1 of IEC 60601-2-64 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 60601-2-64:2015.

The following dates are fixed:
• latest date by which the document has to be (dop) 2015-11-29
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-29
• latest date by which the national
standards conflicting with the
document have to be withdrawn
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.

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 60601-2-64:2014 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 60601-2-68 NOTE Harmonized as EN 60601-2-68.
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
Publication Year Title EN/HD Year
Annex ZA of EN 60601-1:2006 applies except as follows:
Replacement:
IEC 60601-1-2 2014 Medical electrical equipment - EN 60601-1-2 2014
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
Addition:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 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
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/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61217 2011 Radiotherapy equipment - Coordinates, EN 61217 2012
movements and scales
ISO/IEC 14165-321 2009 Information technology - Fibre Channel - - -
Part 321: Audio-Video (FC-AV)
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 60601-2-64 ®
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-64: Particular requirements for the basic safety and essential

performance of light ion beam medical electrical equipment

Appareils électromédicaux –
Partie 2-64: Exigences particulières pour la sécurité de base et

les performances essentielles des appareils électromédicaux par faisceau

d'ions légers
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.60 ISBN 978-2-8322-1825-9

– 2 – IEC 60601-2-64:2014  IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 45
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 45
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 46
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 46
201.15 Construction of ME EQUIPMENT . 46
201.16 ME SYSTEMS . 46
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 46
201.101 ELECTRONIC IMAGING DEVICES (EID) . 47
206 Usability . 47
Annexes . 50
Annex B (informative) Sequence of testing . 50
Annex I (informative) ME SYSTEMS aspects . 50
Bibliography . 51
Index of defined terms used in this particular standard. 52

Figure 201.101 – PATIENT SUPPORT movements . 48
Figure 201.102 – Diagram illustrating example RADIATION HEAD components and
possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 49
Figure 201.103 – Diagram illustrating distance along PATIENT plane to measure
NON-PRIMARY RADIATION ABSORBED DOSE . 49

Table 201.101 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 17

IEC 60601-2-64:2014  IEC 2014 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Particular requirements for the basic safety
and essential performance of LIGHT ION BEAM ME EQUIPMENT

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and
non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates
closely with the International Organization for Standardization (ISO) in accordance with conditions determined
by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent po
...