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 - Amendment 1 - 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
SIST EN 60601-2-64:2015
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
SIST EN 60601-2-64:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-64:2015

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SIST EN 60601-2-64:2015


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

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SIST EN 60601-2-64:2015
EN 60601-2-64:2015
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.
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