EN 60601-2-68:2015

Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

IEC 60601-2-68:2014 applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of kilovoltage and megavoltage X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EBE and X-ray imaging devices, attached or not directly attached to, but in the same radiation shielded area as, and dedicated for use only with, the EBE. This particular standard deals with equipment for real-time X-IGRT, online X-IGRT and offline X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE systems. For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

Medizinische elektrische Geräte - Teil 2-68: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von röntgenstrahlungsbasierten Geräten für die bildgesteuerte Strahlentherapie zur Verwendung mit Elektronenbeschleunigern, Leichtionen-Strahlentherapiesystemen und Radionuklid- Strahlentherapiesystemen

Appareils électromédicaux - Partie 2-68: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de radiothérapie à rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les accélérateurs d’électrons, les appareils de thérapie par faisceau d’ions légers et les appareils de thérapie par faisceau de radionucléides

L'IEC 60601-2-68:2014 s'applique à la sécurité de base et aux performances essentielles des appareils de radiothérapie assistée par imagerie médicale (IGRT) destinés à être utilisés avec les appareils de radiothérapie externes (EBE). La présente norme particulière couvre les aspects de sécurité des dispositifs d'imagerie à rayonnement X sous kilotension et sous mégatension dans une relation géométrique connue avec les EBE à des fins de IGRT. Elle couvre les aspects de communication et les relations entre les EBE et les dispositifs d'imagerie à rayonnement X fixés ou non directement fixés, mais présents dans la même zone protégée contre le rayonnement que les EBE, et dédiés à être utilisés uniquement avec ces appareils. La présente norme particulière traite des appareils de radiothérapie assistée par imagerie médicale en temps réel, en ligne et hors ligne. Elle couvre les procédures de réduction du risque de confiance excessive envers le système d'appareils de radiothérapie assistée par imagerie médicale. Par exemple, le fabricant fournit une interface interactive destinée à l'interaction des utilisateurs avec la correction proposée par le système.

Medicinska električna oprema - 2-68. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih naprav pri slikovno vodeni radioterapiji z elektronskimi pospeševalniki, napravami za lahkoionsko radioterapijo in napravami za radionuklidno radioterapijo

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI rentgenskih naprav pri SLIKOVNO VODENI RADIOTERAPIJI za uporabo s TELERADIOTERAPEVTSKO OPREMO (EBE). Ta standard obravnava varnostne vidike kilovoltažnih (kV) in megavoltažnih (MV) naprav za rentgensko slikanje v znanem geometrijskem odnosu z EBE za namen slikovno vodene radioterapije (IGRT). Obravnava vidike komunikacije in odnosov med TELERADIOTERAPEVTSKO OPREMO in napravami za rentgensko slikanje, neposredno ali posredno pritrjenimi, ki so v enakem pred SEVANJEM zaščitenem območju kot TELERADIOTERAPEVTSKA OPREMA in so namenjene samo uporabi s to opremo.
Ta standard obravnava opremo za IGRT V REALNEM ČASU, IGRT S POVEZAVO in IGRT BREZ POVEZAVE. Zajema postopke za zmanjšanje tveganja pretiranega zanašanja na TELERADIOTERARAPEVTSKI SISTEM IGRT (X-IGRT EBS). Na primer, proizvajalec bo zagotovil interaktiven vmesnik za uporabniško interakcijo s korekcijo, ki jo predlaga sistem.
Če je poglavje ali podpoglavje namenjeno obravnavi SISTEMOV EBE X-IGRT, bo to zapisano v vsebini poglavja ali podpoglavja. Če ni zapisano, poglavje ali podpoglavje obravnava samo OPREMO X-IGRT.
Ta standard z vključenimi TIPSKIMI PRESKUSI in PRESKUSI NA MESTU UPORABE se uporablja za PROIZVAJALSKE in nekatere vgradne vidike SISTEMOV EBE X-IGRT, ki
• so namenjeni 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. STACIONARNA RADIOTERAPIJA ali RADIOTERAPIJA S PREMIČNIM ŽARKOM,
• se vzdržujejo v skladu s priporočili, podanimi v NAVODILIH ZA UPORABO,
• so predmet rednih pregledov zagotavljanja kakovosti, delovanja in umerjanja, ki jih izvaja KVALIFICIRANA OSEBA.
OPOMBA: V tem standardu se vsa sklicevanja na obrat nanašajo na obrat v prostorih ODGOVORNE ORGANIZACIJE.

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/292 - Mandate in the field of standardization to CEN, CENELEC and ETSI relative to the safety of consumers and children - Product information
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-68:2015 - Medical electrical equipment - Part 2-68: Particular requirements for basic safety and essential 63 performance of X-ray Based Image Guided Radiotherapy 64 equipment for use with electron accelerators, light ion beam 65 therapy equipment and radionuclide beam therapy equipment

Relations

• Revised: prEN IEC 60601-2-68 - Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of x-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
• Effective Date: 18-Aug-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNLKQDSUDYSULVOLNRYQRYRGHQLUDGLRWHUDSLML]
HOHNWURQVNLPLSRVSHãHYDOQLNLQDSUDYDPL]DODKNRLRQVNRUDGLRWHUDSLMRLQ
QDSUDYDPL]DUDGLRQXNOLGQRUDGLRWHUDSLMR
Medical electrical equipment - Part 2-68: Particular requirements for basic safety and
essential 63 performance of X-ray Based Image Guided Radiotherapy 64 equipment for
use with electron accelerators, light ion beam 65 therapy equipment and radionuclide
beam therapy equipment
Medizinische elektrische Geräte - Teil 2-68: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von röntgenstrahlungsbasierten
Geräten für die bildgesteuerte Strahlentherapie zur Verwendung mit
Elektronenbeschleunigern, Leichtionen-Strahlentherapiesystemen und Radionuklid-
Strahlentherapiesystemen
Appareils électromédicaux - Partie 2-68: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de radiothérapie guidés par image
radiologique, destinés à être utilisés avec les accélérateurs d'électrons, les appareils de
thérapie par faisceau ionique lumineux et les appareils de thérapie par faisceau
provenant de radionucléides
Ta slovenski standard je istoveten z: EN 60601-2-68:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-68

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-68: Particular requirements
for the basic safety and essential performance of X-ray-based
image-guided radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and radionuclide
beam therapy equipment
(IEC 60601-2-68:2014)
Appareils électromédicaux - Partie 2-68: Exigences Medizinische elektrische Geräte - Teil 2-68: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de radiothérapie à rayonnement wesentlichen Leistungsmerkmale von
X assistée par imagerie médicale, destinés à être utilisés röntgenstrahlungsbasierten Geräten für die bildgesteuerte
avec les accélérateurs d'électrons, les appareils de thérapie Strahlentherapie zur Verwendung mit
par faisceau d'ions légers et les appareils de thérapie par Elektronenbeschleunigern, Leichtionen-
faisceau de radionucléides Strahlentherapiesystemen und Radionuklid-
(IEC 60601-2-68:2014) Strahlentherapiesystemen
(IEC 60601-2-68:2014)
This European Standard was approved by CENELEC on 2014-10-09. 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 60601-2-68:2015 E
Foreword
The text of document 62C/595/FDIS, future edition 1 of IEC 60601-2-68 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 60601-2-68:2015.

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 60601-2-68:2014 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 60336:2005 NOTE Harmonized as EN 60336:2005 (not modified).
IEC 60364-7-710:2002 NOTE Harmonized as HD 60364-7-710:2012 (modified).
IEC 60522:1999 NOTE Harmonized as EN 60522:1999 (not modified).
1)
IEC 62220-1:2003 NOTE Harmonized as EN 62220-1:2004 (not modified).

1)
Superseded by EN 62220-1-1:2015 (IEC 62220-1-1:2015): DOW = 2018-04-16.
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:
Amendment:
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral Standard: Radiation protection in
diagnostic X-ray equipment
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
Part 1-6: General requirements for basic
+A1 2013 +A1 2015
safety and essential performance -
Collateral standard: Usability
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 60601-2-4 2010 Medical electrical equipment - EN 60601-2-4 2011
Part 2-4: Particular requirements for the
basic safety and essential performance of
cardiac defibrillators
IEC 60601-2-44 2009 Medical electrical equipment - EN 60601-2-44 2009
Part 2-44: Particular requirements for the
+A11 2011
basic safety and essential performance of
+A1 2012 X-ray equipment for computed tomography +A1 2012
Publication Year Title EN/HD Year
IEC 60731 2011 Medical electrical equipment - Dosimeters EN 60731 2012
with ionization chambers as used in
radiotherapy
IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms
IEC 60976 2007 Medical electrical equipment - Medical EN 60976 2007
electron accelerators - Functional
performance characteristics
IEC 61217 2011 Radiotherapy equipment - Coordinates, EN 61217 2012
movements and scales
IEC 61223-3-5 2004 Evaluation and routine testing in medical EN 61223-3-5 2004
imaging departments -
Part 3-5: Acceptance tests - Imaging
performance of computed tomography
X-ray equipment
IEC 61262-7 1995 Medical electrical equipment - EN 61262-7 1995
Characteristics of electro-optical X-ray
image intensifiers -
Part 7: Determination of the modulation
transfer function
IEC 62083 2009 Medical electrical equipment - EN 62083 2009
Requirements for the safety of
radiotherapy treatment planning systems
IEC 62274 2005 Medical electrical equipment - Safety of EN 62274 2005
radiotherapy record and verify systems
IEC 62366 2007 Medical devices - Application of usability - -
engineering to medical devices
IEC 62396-1 2012 Process management for avionics - - -
Atmospheric radiation effects -
Part 1: Accommodation of atmospheric
radiation effects via single event effects
within avionics electronic equipment
IEC 62563-1 2009 Medical electrical equipment - Medical EN 62563-1 2010
image display systems -
Part 1: Evaluation methods
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 60601-2-68 ®
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-68: Particular requirements for the basic safety and essential performance

of X-ray-based image-guided radiotherapy equipment for use with electron

accelerators, light ion beam therapy equipment and radionuclide beam therapy

equipment
Appareils électromédicaux –
Partie 2-68: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils de radiothérapie à rayonnement X assistée par

imagerie médicale, destinés à être utilisés avec les accélérateurs d’électrons, les

appareils de thérapie par faisceau d’ions légers et les appareils de thérapie par

faisceau de radionucléides
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.60 ISBN 978-2-8322-1839-6

– 2 – IEC 60601-2-68:2014 © IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 18
201.5 General requirements for testing ME EQUIPMENT . 19
201.6 Classification of me equipment and me systems . 19
201.7 ME EQUIPMENT identification, marking and documents . 19
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 25
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 28
201.10 Protection against unwanted and excessive radiation HAZARDS . 32
201.11 Protection against excessive temperatures and other HAZARDS . 34
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 34
201.13 Hazardous situations and fault conditions for me equipment . 34
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 35
201.15 Construction of me equipment. 35
201.16 ME SYSTEMS . 35
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 35
...