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 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.

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 60601-2-68:2025 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
• vérifiés périodiquement par une PERSONNE QUALIFIEE selon un programme d'assurance qualité qui porte sur le contrôle des performances et de l'étalonnage.
L'IEC 60601-2-68:2025 annule et remplace la première édition parue en 2014. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) alignement sur les nouvelles éditions des n

General Information

• Status: Published
• Publication Date: 03-Feb-2025
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 1 - TC 62/SC 62C/WG 1
• Current Stage: PPUB - Publication issued
• Start Date: 10-Jan-2025
• Due Date: 04-Feb-2025
• Completion Date: 04-Feb-2025

Relations

• Revises: IEC 60601-2-68:2014 - 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: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-68 ®
Edition 2.0 2025-02
REDLINE VERSION
INTERNATIONAL
STANDARD
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
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IEC 60601-2-68 ®
Edition 2.0 2025-02
REDLINE VERSION
INTERNATIONAL
STANDARD
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.60 ISBN 978-2-8327-0203-1

– 2 – IEC 60601-2-68:2025 RLV © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 13
201.4 General requirements . 23
201.5 General requirements for testing ME EQUIPMENT . 23
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 24
201.7 ME EQUIPMENT identification, marking and documents . 24
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 34
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 37
201.10 Protection against unwanted and excessive radiation HAZARDS . 46
201.11 Protection against excessive temperatures and other HAZARDS . 47
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 48
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 48
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 49
201.15 Construction of ME EQUIPMENT . 50
201.16 ME SYSTEMS . 50
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 50
201.101 Reference data for X-IGRT . 51
201.102 X-IGRT imaging . 55
201.103 IGRT analysis and correction . 63
201.104 Operation of ME EQUIPMENT parts from outside the facility . 66
203 RADIATION protection in diagnostic X-RAY EQUIPMENT . 67
206 Usability . 69
Annexes . 70
Annex B (informative) Sequence of testing .
Annex A (informative) Sequence of testing. 71
Annex I (informative) ME SYSTEMS aspects . 72
Annex AA (informative) Particular guidance and rationale . 73
Annex BB (informative) Measuring CTDI . 76
free air
Bibliography . 77
Index of defined terms used in this document . 79

Figure AA.1 – Signals related to IGRT LATENCY . 74
Figure 201.101 – PATIENT SUPPORT movements .

Table 201.101 – Data required in the technical description . 27
Table 201.102 – Clauses and subclauses in this document that require the provision of
information in the ACCOMPANYING DOCUMENTS DOCUMENTATION, INSTRUCTIONS FOR USE
and the technical description . 29
Table 201.103 – Example test pattern for CTDI for kV . 60
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
equivalent requirements for CT SCANNER, x-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY
EQUIPMENT for RADIOSCOPY . 73

– 4 – IEC 60601-2-68:2025 RLV © 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
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This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition IEC 60601-2-68:2014. A vertical bar appears in the margin
wherever a change has been made. Additions are in green text, deletions are in
strikethrough red text.
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 60601-2-44:2009, 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);
MECHANICAL HAZARDS, RADIATION HAZARDS,
c) introduction of updated requirements related to
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 de
...