SIST EN IEC 60601-2-68:2025
(Amendment)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)
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)
Ta del standarda IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI rentgenskih naprav pri SLIKOVNO VODENI RADIOTERAPIJI za uporabo s TELERADIOTERAPEVTSKO OPREMO (EBE).
Ta dokument zajema varnostne vidike kilovoltnih (kV) in megavoltnih (MV) naprav za rentgensko slikanje, integriranih v določeno geometrijsko razmerje s teleradioterapevtsko opremo za namen slikovno vodene radioterapije (IGRT). Zajema 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 dokument obravnava opremo za SLIKOVNO VODENO RADIOTERAPIJO BREZ POVEZAVE, SLIKOVNO VODENO RADIOTERAPIJO S POVEZAVO in SLIKOVNO VODENO RADIOTERAPIJO V REALNEM ČASU. Zajema postopke za zmanjšanje tveganja pretiranega zanašanja na TELERADIOTERAPEVTSKI SISTEM ZA SLIKOVNO VODENO RADIOTERAPIJO. Pri izvajanju slikovno vodene radioterapije s povezavo bo PROIZVAJALEC na primer zagotovil interaktiven vmesnik za uporabniško interakcijo s korekcijo, ki jo predlaga sistem.
Ta dokument se ne uporablja za NAPRAVE CT, RENTGENSKO OPREMO za RADIOGRAFIJO in RENTGENSKO OPREMO za RADIOSKOPIJO, ki niso namenjene uporabi za slikovno vodeno radioterapijo.
Zahteve, ki se preskušajo v skladu z drugim standardom, lahko določi proizvajalec. Če so te zahteve enakovredne, ponovno preskušanje ni potrebno, temveč je kot dokazilo mogoče uporabiti izjave o skladnosti ali poročila o preskusih proizvajalca NAPRAVE CT, RENTGENSKE OPREME za RADIOGRAFIJO oziroma RENTGENSKE OPREME za RADIOSKOPIJO.
Če se OPREMA ZA SLIKOVNO VODENO RADIOTERAPIJO uporablja v kombinaciji z OPREMO ZA MERJENJE ELEKTRIČNE ENERGIJE, zahtev, ki so enake tako za OPREMO ZA SLIKOVNO VODENO RADIOTERAPIJO kot za OPREMO ZA MERJENJE ELEKTRIČNE ENERGIJE (npr. NAPRAVA ZA NAMEŠČANJE PREISKOVANCA), ni treba preskusiti dvakrat, temveč jih je mogoče sprejeti kot preskušene z OPREMO ZA MERJENJE ELEKTRIČNE ENERGIJE.
Ta dokument se uporablja za RENTGENSKO OPREMO za RADIOGRAFIJO, RADIOSKOPIJO in RAČUNALNIŠKO TOMOGRAFIJO, ki je namenjena uporabi za SLIKOVNO VODENO RADIOTERAPIJO.
Če je točka ali podtočka posebej namenjena uporabi za TELERADIOTERAPEVTSKE SISTEME ZA SLIKOVNO VODENO RADIOTERAPIJO, bo to zapisano v vsebini točke ali podtočke. Če ni zapisano, se točka ali podtočka uporablja samo za OPREMO ZA SLIKOVNO VODENO RADIOTERAPIJO. Ta dokument z vključenimi TIPSKIMI PRESKUSI in PRESKUSI NA MESTU UPORABE se uporablja za PROIZVAJALSKE in nekatere namestitvene vidike TELERADIOTERAPEVTSKIH SISTEMOV ZA SLIKOVNO VODENO RADIOTERAPIJO, ki: • so namenjeni za OBIČAJNO UPORABO, pri čemer jih pod vodstvom ODGOVORNE ORGANIZACIJE upravljajo KVALIFICIRANE OSEBE z zahtevanimi veščinami za določeno medicinsko uporabo, za določene opredeljene klinične namene (npr. STACIONARNA RADIOTERAPIJA ali RADIOTERAPIJA S PREMIČNIM ŽARKOM); • jih je treba vzdrževati v skladu s priporočili, podanimi v NAVODILIH ZA UPORABO; ter • so predmet rednih pregledov zagotavljanja kakovosti, delovanja in umerjanja, ki jih opravi KVALIFICIRANA OSEBA.
OPOMBA: V tem dokumentu se vsa sklicevanja na namestitev navezujejo na namestitev v prostorih ODGOVORNE ORGANIZACIJE.
General Information
Relations
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 . 49
201.103 IGRT analysis and correction . 56
201.104 Operation of ME EQUIPMENT parts from outside the facility . 59
203 RADIATION protection in diagnostic X-RAY EQUIPMENT . 60
206 Usability . 62
Annexes . 63
Annex A (informative) Sequence of testing. 64
Annex I (informative) ME SYSTEMS aspects . 64
Annex AA (informative) Particular guidance and rationale . 65
Annex BB (informative) Measuring CTDI . 68
free air
Bibliography . 69
Index of defined terms used in this document . 71
Figure AA.1 – Signals related to IGRT LATENCY . 66
Table 201.101 – Data required in the technical description . 26
Table 201.102 – Clauses and subclauses in this document that require the provision of
information in the ACCOMPANYING DOCUMENTATION, INSTRUCTIONS FOR USE and the
technical description . 27
Table 201.103 – Example test pattern for CTDI for kV . 54
free air
Table AA.1 – Clauses of the standard that contain requirements for X-IGRT IMAGING
COMPONENTS and related clauses of IEC 60601-2-44 and IEC 60601-2-54 with
IEC 60601-2-68:2025 © IEC 2025 – 3 –
equivalent requirements for CT SCANNER, x-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY
EQUIPMENT for RADIOSCOPY . 65
– 4 – IEC 60601-2-68:2025 © IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
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 national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-68 has been prepared by IEC subcommittee 62C: Equipment for radiotherapy,
nuclear medicine and radiation dosimetry, of IEC technical committee 62: Medical equipment,
software, and systems. It is an International Standard.
This second edition 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 60601-2-68:2025 © IEC 2025 – 5 –
– 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.
The text of this International Standard is based on the following documents:
Draft Report on voting
62C/927/FDIS 62C/941/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, AND
IEC 60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g., Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g., 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this document are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
– 6 – IEC 60601-2-68:2025 © IEC 2025
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IEC 60601-2-68:2025 © IEC 2025 – 7 –
INTRODUCTION
Modern RADIOTHERAPY practices utilize information from various imaging modalities, acquired
prior to initiating administration of the therapy, to plan the TREATMENT. The imaging provides
information about the location of the TARGET VOLUME and other anatomical features so that a
TREATMENT PLAN can be developed that provides an optimal dose distribution to have the best
chance of achieving the intended effect of TREATMENT while minimizing side effects.
However, difficulties arise when trying to administer the RADIATION, since TARGET
VOLUMES/critical structures are constantly moving within the body. For example, in parts of the
body moving with respiration, the TARGET VOLUMES/critical structures may change position or
shape during the RADIATION BEAM delivery throughout any given fraction. Furthermore, a course
of therapy can extend over many days, during which the TARGET VOLUME/PATIENT can shrink or
grow or move. Hence, the exact location of the TARGET VOLUME/critical structures can change
between the time of TREATMENT PLANNING imaging and the actual administration of a TREATMENT.
IMAGE-GUIDED RADIOTHERAPY (IGRT) combines planar or volumetric imaging during the course of
RADIOTHERAPY to adjust the TREATMENT delivery based on the PATIENT anatomy and PATIENT
position. This enables the OPERATOR or EXTERNAL BEAM EQUIPMENT (EBE) to adjust the RADIATION
BEAM delivery based on the imaging information, such as the position of the TARGET VOLUME,
critical organs or other reference features, to compensate for anatomical changes including
internal organ motions or TREATMENT setup uncertainties. The increased accuracy and precision
achieved allows higher doses of RADIATION to be delivered to the TARGET VOLUME and a reduction
in the margin of healthy cells affected by the RADIATION. This is often used in conjunction with
other monitoring equipment.
This document establishes requirements to be complied with by MANUFACTURERS in the design
and construction of X-RAY IGRT EQUIPMENT (X-IGRT).
This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging
devices in a known geometrical relationship with an EXTERNAL BEAM EQUIPMENT such as an
ELECTRON ACCELERATOR, LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT or RADIONUCLIDE BEAM
THERAPY EQUIPMENT, 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.
When performing a HAZARD ANALYSIS, the MANUFACTURER should consider relevant diagnostic
standards. For example, the IMAGE DISPLAY DEVICE quality is specified in IEC documents in
regard to diagnostic use (e.g., IEC 62563-1:2009). However, since IGRT usage does not
necessarily have such high requirements, it is left to the MANUFACTURER to specify what is
required for use with their X-IGRT EQUIPMENT.
This document deals with the safety aspect of image acquisitions, image analysis, data transfer
and TREATMENT replanning or EBE/PATIENT repositioning.
This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT, and REAL-TIME X-IGRT.
X-IGRT EQUIPMENT is also related to the following current publications:
– IEC 60601-2-1
– IEC 60601-2-44
– IEC 60601-2-64
– IEC 62083
– IEC 61217
– IEC 62274
– 8 – IEC 60601-2-68:2025 © IEC 2025
This document will focus on the safety aspects of the primary function of X-IGRT. It will not focus
on emerging technologies within the field so as to not hinder progress, yet it will define a safe
way of achieving X-IGRT.
IEC 60601-2-68:2025 © IEC 2025 – 9 –
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
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 * Scope
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based
This part of IEC 60601 applies to the
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, that are not intended for use for IGRT.
Requirements that are being tested according to another standard can be identified by the
manufacturer. If these requirements are equivalent, retesting is not required, but instead
evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY for
RADIOSCOPY manufacturer's 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 to 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.
– 10 – IEC 60601-2-68:2025 © IEC 2025
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
QUALIFIED
• subject to regular quality assurance performance and calibration checks by a
PERSON.
NOTE In this document, all references to installation refer to the installation in the RESPONSIBLE ORGANIZATION'S
premises.
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for X-IGRT EQUIPMENT and X-IGRT EBE SYSTEMS.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.
IEC 60601-1-3 and IEC 60601-1-6 apply as modified in Clause 203 and Clause 206
respectively. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 and IEC 60601-1-11 do not apply.
All other published collateral standards in the IEC 60601-1 series apply as published.
All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
IEC 60601-2-68:2025 © IEC 2025 – 11 –
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) or
applicable collateral standard with the prefix "20x" where x is the final digit(s) of the collateral
standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of Clause
4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are specified by the use of
the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005, IEC 60601-
1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through 3.154,
additional definitions in this document are numbered beginning from 201.3.201. Additional
annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, for example 202
for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral
standards and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the bibliography.
– 12 – IEC 60601-2-68:2025 © IEC 2025
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
Replacement:
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray
equipment
IEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008/AMD2:2021
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-1:2020, 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 – Part 2-4: 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 4-3 : Testing and measurement
techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61217:2011, Radiotherapy equipment – Coordinates, movements and scales
IEC 62563-1:2009, Medical electrical equipment – Medical image display systems – Part 1:
Evaluation methods
CISPR 11, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics – Limits and methods of measurement
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-2-1:2020,
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020, and
IEC TR 60788:2004 apply, except as follows:
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
IEC 60601-2-68:2025 © IEC 2025 – 13 –
Additional terms and definitions:
201.3.201
COMPUTED TOMOGRAPHY DOSE INDEX 100
CTDI
integral of the DOSE PROFILE representative of a single axial scan along a line perpendicular to
the TOMOGRAPHIC PLANE divided by N × T according to the following:
for N × T less than or equal to 40 mm
+50mm Dy
( )
CTDI = dy
∫
−50mm
N×T
for N × T greater than 40 mm (all IGRT IMAGING PROTOCOL except collimation are kept the same
for these measurements)
+50mm Dy CTDI
( )
Ref free air, N×T
CTDI dy×
∫
−50mm
N×T CTDI
( )
free air, Ref
Ref
where
DOSE PROFILE representative of a single axial scan along a line
D(y) is the
perpendicular to the TOMOGRAPHIC PLANE, where dose is reported as
ABSORBED DOSE in air and is evaluated within a polymethylmethacrylate
(PMMA) dosimetry PHANTOM (see 201.102.6.2);
(N × T) is a specific N × T of 20 mm or the largest N x T available not greater
Ref
than 20 mm;
D (y) is the DOSE PROFILE representative of a single axial scan along a line
Ref
perpendicular to the TOMOGRAPHIC PLANE, where dose is reported as
ABSORBED DOSE in air and is evaluated within a polymethylmethacrylate
PHANTOM (see 201.102.6.2) for (N × T) ;
(PMMA) dosimetry
Ref
CTDI is the CTDI (201.3.202) for a specific value of N × T;
free air, N × T free air
CTDI is the CTDI (201.3.202) for (N × T) ;
free air, Ref free air Ref
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan
of the X-ray source;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS.
Note 1 to entry: The dose is reported as ABSORBED DOSE to air, but for practical purposes the evaluation of ABSORBED
DOSE to air within a PMMA dosimetry PHANTOM is well approximated by measurement of the AIR KERMA.
Note 2 to entry: This definition assumes that the DOSE PROFILE is centred on y = 0.
Note 3 to entry: A single axial scan is typically a 360° rotation of the X-ray source. For CBCT partial rotations are
still considered as a single axial scan.
Note 4 to entry: When the TOMOGRAPHIC SECTIONS overlap, e.g., in CT SCANNERS with a "y-flying FOCAL SPOT" or
with CBCT modes that merge multiple scans, the denominator of the integral needs to be replaced by the total nominal
width along y of overlapping tomographic sections. For example, if the percentage of overlap is 50 %, then the
denominator would be replaced with 0,5 x N x T.
Note 5 to entry: Typically, the y-axis is the axis of rotation (the y-axis corresponds to the z-axis in the DICOM
coordinate system).
Note 6 to entry: The CTDI is designed to include most of the scattered RADIATION.
Note 7 to entry: See IEC 60601-2-44:2009/AMD1:2012, Annex CC for more explanation.
Note 8 to entry: It is assumed for MV CBCT that an appropriate calibrated pencil chamber is used.
=
– 14 – IEC 60601-2-68:2025 © IEC 2025
[SOURCE: IEC 60601-2-44:2009/AMD1:2012, 201.3.203, modified – Notes 3, 4 and 5 to entry
have been extended, and Note 8 to entry added.]
201.3.202
COMPUTED TOMOGRAPHY DOSE INDEX FREE-IN-AIR
CTDI
free air
integral of the DOSE PROFILE representative of a single axial scan along a line through the
ISOCENTRE and perpendicular to the TOMOGRAPHIC PLANE divided by N × T according to the
following
+L/2 Dy
( )
CTDI = dy
free air
∫
−L/2
N×T
where
D(y) is the DOSE PROFILE representative of a single axial scan along a line through ISOCENTRE
and perpendicular to the TOMOGRAPHIC PLANE, where dose is reported as ABSORBED DOSE
in air and is evaluated free-in-air in the absence of a PHANTOM and the PATIENT SUPPORT;
N is the number of TOMOGRAPHIC SECTIONS produced in a single axial scan of the X-ray
source;
T is the NOMINAL TOMOGRAPHIC SECTION THICKNESS;
L is at least (N × T) +40 mm.
Note 1 to entry: This definition assumes that the DOSE PROFILE is centred on y = 0. The y axis corresponds to the z
axis in the DICOM coordinate system.
Note 2 to entry: When the TOMOGRAPHIC SECTIONS overlap, e.g., in CT SCANNERS with a "y-flying FOCAL SPOT" or
with CBCT modes that merges multiple scans, the denominator of the integral needs to be replaced by the total
nominal width along y of overlapping tomographic sections. For example, if the percentage of overlap is 50 %, then
the denominator would be replaced by 0,5 × N × T.
Note 3 to entry: Typically, a RADIATION DETECTOR of length L or longer is used. Annex DD provides an example for
alternate measurements.
Note 4 to entry: For CBCT, the imaging is not slice based and N × T is the scan length along a line perpendicular to
the TOMOGRAPHIC PLANE with the NOMINAL collimation.
Note 5 to entry: It is assumed for MV CBCT that an appropriate calibrated pencil chamber or ion chamber, and a
build-up cap is used.
[SOURCE: IEC 60601-2-44:2009/AMD1:2012, 201.3.215, modified – Note 1 and 2 to entry have
been extended and Notes 4 and 5 to entry added.]
201.3.203
CONE BEAM COMPUTED TOMOGRAPHY
CBCT
comp
...
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