SIST EN IEC 60601-2-68:2025

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 60601-2-68:2025)

IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT 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 EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be:
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 80601-2-68:2024 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new editions of the relevant standards:
– IEC 60601-2-1:2020;
– IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016;
– IEC 60601-2-64:2014;
b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE);
c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.

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 (IEC 60601-2-68:2025)

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 (IEC 60601-2-68:2025)

L'IEC 60601-2-68:2025 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE destinés à être utilisés avec les APPAREILS DE RADIOTHERAPIE EXTERNES (EBE). Le présent document couvre les aspects de sécurité des dispositifs d'imagerie à rayonnement X sous kilotension (kV) et sous mégatension (MV) intégrés dans une relation géométrique spécifiée avec les EBE à des fins de RADIOTHERAPIE ASSISTEE PAR IMAGERIE MEDICALE. Il couvre les aspects de communication et les relations entre les APPAREILS DE RADIOTHERAPIE EXTERNES 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 APPAREILS DE RADIOTHERAPIE EXTERNES, et destinés à être utilisés uniquement avec ces appareils. Le présent document traite des APPAREILS DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE HORS LIGNE, EN LIGNE et EN TEMPS REEL. Il couvre les procédures de réduction du risque de confiance excessive envers le SYSTEME EBE X-IGRT. Par exemple, dans le cas d'une RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE EN LIGNE, le FABRICANT fournit une interface interactive destinée à l'interaction des utilisateurs avec la correction proposée par le système. Le présent document ne s'applique pas aux TOMODENSITOMETRES, aux APPAREILS A RAYONNEMENT X pour la RADIOGRAPHIE et aux APPAREILS A RAYONNEMENT X pour la RADIOSCOPIE, qui ne sont pas conçus pour être utilisés pour la RADIOTHERAPIE ASSISTEE PAR IMAGERIE MEDICALE. Les exigences soumises à l'essai conformément à une autre norme peuvent être identifiées par le fabricant. Lorsque ces exigences sont équivalentes, de nouveaux essais ne sont pas exigés, mais la conformité peut être prouvée par les déclarations de conformité ou les rapports d'essai relatifs aux TOMODENSITOMETRES, aux APPAREILS A RAYONNEMENT X pour la RADIOGRAPHIE ou aux APPAREILS A RAYONNEMENT X pour les APPAREILS DE RADIOSCOPIE fournis par le fabricant.
Lorsqu'un APPAREIL DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE est combiné à un APPAREIL ELECTROMEDICAL, toutes les exigences communes à l'APPAREIL DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE et à l'APPAREIL ELECTROMEDICAL (par exemple, un POSITIONNEUR DE PATIENT) n'ont pas besoin d'être soumises à l'essai deux fois, mais peuvent être admises comme ayant été soumises à l'essai par l'APPAREIL ELECTROMEDICAL. Le présent document s'applique aux APPAREILS A RAYONNEMENT X pour la RADIOGRAPHIE, la RADIOSCOPIE et la TOMODENSITOMETRIE utilisées pour la RADIOTHERAPIE ASSISTEE PAR IMAGERIE MEDICALE. Si un article ou un paragraphe est destiné spécifiquement à s'appliquer aux SYSTEMES EBE X IGRT, le contenu de cet article ou de ce paragraphe l'indique de manière explicite. Si tel n'est pas le cas, l'article ou le paragraphe s'applique uniquement aux APPAREILS X-IGRT.
Le présent document, y compris les ESSAIS DE TYPE et les ESSAIS SUR LE SITE, s'applique respectivement au FABRICANT et à certains aspects d'installation des SYSTEMES EBE X-IGRT destinés à être:
• pour une UTILISATION NORMALE, manipulés, sous la responsabilité de l'ORGANISME RESPONSABLE, par des PERSONNES QUALIFIEES qui disposent des compétences exigées pour une application médicale particulière, à des fins cliniques spécifiées particulières, par exemple RADIOTHERAPIE A CHAMP FIXE ou RADIOTHERAPIE CINETIQUE,
• entretenus selon les recommandations données dans les INSTRUCTIONS D'UTILISATION, et
• vérifi

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 (IEC 60601-2-68:2025)

General Information

• Status: Published
• Public Enquiry End Date: 26-Oct-2023
• Publication Date: 13-May-2025
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.60 - Therapy equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-May-2025
• Due Date: 10-Jul-2025
• Completion Date: 14-May-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• 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
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: EN IEC 60601-2-68:2025 - 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

Relations

• Replaces: 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
• Effective Date: 01-Jun-2025

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2025
Nadomešča:
SIST EN 60601-2-68:2015
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 (IEC 60601-2-68:2025)
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 60601-2-68:2025)
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 (IEC 60601-2-68:2025)
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 (IEC 60601-2-68:2025)
Ta slovenski standard je istoveten z: EN IEC 60601-2-68:2025
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 IEC 60601-2-68

NORME EUROPÉENNE
EUROPÄISCHE NORM April 2025
ICS 11.040.60 Supersedes EN 60601-2-68:2015
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 60601-2-68:2025)
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 60601-2-68:2025) Strahlentherapiesystemen
(IEC 60601-2-68:2025)
This European Standard was approved by CENELEC on 2025-03-11. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-68:2025 E

European foreword
The text of document 62C/927/FDIS, future edition 2 of IEC 60601-2-68, prepared by SC 62C
"Equipment for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Medical
equipment, software, and systems" was submitted to the IEC-CENELEC parallel vote and approved
by CENELEC as EN IEC 60601-2-68:2025.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-04-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-04-30
document have to be withdrawn
This document supersedes EN 60601-2-68:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-68:2025 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 standard indicated:
IEC 60336:2020 NOTE Approved as EN IEC 60336:2021 (not modified)
1 2
IEC 60364-7-710:2021 NOTE Approved as HD 60364-7-710:— (not modified) + A11:—
IEC 60601-1-9 NOTE Approved as EN 60601-1-9
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
IEC 60601-2-4:2010 NOTE Approved as EN 60601-2-4:2011 (not modified)
IEC 60601-2-8 NOTE Approved as EN 60601-2-8
IEC 60601-2-11:2013 NOTE Approved as EN 60601-2-11:2015 (not modified)
IEC 60601-2-17 NOTE Approved as EN 60601-2-17
IEC 60601-2-28:2017 NOTE Approved as EN IEC 60601-2-28:2019 (not modified)
IEC 60601-2-44:2009 NOTE Approved as EN 60601-2-44:2009 (not modified)
+ A11:2011
Under preparation. Stage at the time of publication: HD 60364-7-710:2025.
Under preparation. Stage at the time of publication: HD 60364-7-710:2025/A11:2025.
IEC 60601-2-44:2009/A1:2012 NOTE Approved as EN 60601-2-44:2009/A1:2012 (not modified)
IEC 60601-2-44:2009/A2:2016 NOTE Approved as EN 60601-2-44:2009/A2:2016 (not modified)
IEC 60601-2-54 NOTE Approved as EN IEC 60601-2-54
IEC 60601-2-64:2014 NOTE Approved as EN 60601-2-64:2015 (not modified)
IEC 60731:2011 NOTE Approved as EN 60731:2012 (not modified)
IEC 60976:2007 NOTE Approved as EN 60976:2007 (not modified)
IEC 61223-3-5:2019 NOTE Approved as EN IEC 61223-3-5:2019 (not modified)
IEC 61262-7:1995 NOTE Approved as EN 61262-7:1995 (not modified)
IEC 61674 NOTE Approved as EN IEC 61674
IEC 62083:2009 NOTE Approved as EN 62083:2009 (not modified)
IEC 62220-1-1:2015 NOTE Approved as EN 62220-1-1:2015 (not modified)
IEC 62274:2005 NOTE Approved as EN 62274:2005 (not modified)
IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where 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.cencenelec.eu.
Clause 2 of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement:
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- - + corrigendum Mar. 2010
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
+ A2 2021 + A2 2021
Addition:
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
- - + A13 2024
As impacted by EN 60601-1:2006/Corrigendum Mar. 2010, EN 60601-1:2006/A1:2013,
EN 60601-1:2006/A1:2013/AC:2014, EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021,
EN 60601-1:2006/AC:2022-12 and EN 60601-1:2006/A13:2024,
Publication Year Title EN/HD Year
IEC 60601-2-1 2020 Medical electrical equipment - Part 2-1: EN IEC 60601-2-1 2021
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 - Part 2-4: EN 60601-2-4 2011
Particular requirements for the basic safety
and essential performance of cardiac
defibrillators
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 61000-4-3 - Electromagnetic compatibility (EMC) - Part EN IEC 61000-4-3 -
4-3 : Testing and measurement techniques
- Radiated, radio-frequency,
electromagnetic field immunity test
IEC 61217 2011 Radiotherapy equipment - Coordinates, EN 61217 2012
movements and scales
IEC 62563-1 2009 Medical electrical equipment - Medical EN 62563-1 2010
image display systems - Part 1: Evaluation
methods
CISPR 11 2024 Industrial, scientific and medical equipment - -
- Radio-frequency disturbance
characteristics - Limits and methods of
measurement
IEC 60601-2-68 ®
Edition 2.0 2025-02
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
INTERNATIONALE
ICS 11.040.60  ISBN 978-2-8327-0134-8

– 2 – IEC 60601-2-68:2025 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 12
201.4 General requirements . 22
201.5 General requirements for testing ME EQUIPMENT . 22
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 23
201.7 ME EQUIPMENT identification, marking and documents . 23
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 31
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 34
201.10 Protection against unwanted and excessive radiation HAZARDS . 40
201.11 Protection against excessive temperatures and other HAZARDS . 42
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 43
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 43
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 43
201.15 Construction of ME EQUIPMENT . 44
201.16 ME SYSTEMS . 44
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 44
201.101 Reference data for X-IGRT . 45
201.102 X-IGRT imaging .
...