FprEN IEC 60601-2-68:2024
(Main)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
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.
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 60601-2-68:2025 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
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-68:2015/oprA1:2023
01-oktober-2023
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 - Dopolnilo A1
Amendment 1 - 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
Amendement 1 - 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
Ta slovenski standard je istoveten z: EN 60601-2-68:2015/prA1:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-68:2015/oprA1:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN 60601-2-68:2015/oprA1:2023
SIST EN 60601-2-68:2015/oprA1:2023
62C/876/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-68/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-08-04 2023-10-27
SUPERSEDES DOCUMENTS:
62C/774/CD, 62C/834A/CC
IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 62B
Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In So me Countries” clauses
to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Amendment 1 - 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
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
SIST EN 60601-2-68:2015/oprA1:2023
62C/876/CDV – 2 – IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023
PROPOSED STABILITY DATE: 2029
NOTE FROM TC/SC OFFICERS:
For supporting information please see 62C/877/INF, which contains IEC 60601-2-68:2014 with the changes proposed
by this CDV, visibly incorporated.
SIST EN 60601-2-68:2015/oprA1:2023
IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023 – 3 – 62C/876/CDV
1 CONTENTS
3 FOREWORD . 5
4 INTRODUCTION to Amendment 1 . 7
5 INTRODUCTION . 8
6 201.1 Scope, object and related standards . 10
7 201.2 Normative references . 10
8 201.3 Terms and definitions . 11
9 201.5 General requirements for testing ME EQUIPMENT . 17
10 201.7 ME EQUIPMENT identification, marking and documents . 18
11 201.8 Protection against electrical hazards from me equipment . 25
12 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 27
13 201.10 Protection against unwanted and excessive RADIATION HAZARDS . 33
14 201.11 Protection against excessive temperatures and other HAZARDS . 34
15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 34
16 201.12.3 ALARM SYSTEMS. 34
17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 34
18 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 35
19 201.101 Reference data for X-IGRT . 36
20 201.102 X-IGRT imaging . 38
21 201.103 IGRT analysis and correction . 42
22 201.104 Operation of ME EQUIPMENT parts from outside the facility . 43
23 203 RADIATION protection in diagnostic X-RAY EQUIPMENT. 44
24 203.4 General requirements . 44
25 203.4.1 Statement of compliance . 44
26 203.6.3.2 Reproducibility of the RADIATION output . 44
27 203.8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD and
28 IMAGE RECEPTION AREA . 44
29 203.8.4 Confinement of EXTRA-FOCAL RADIATION . 44
30 203.10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR
31 . 45
32 203.10.2 Information in the ACCOMPANYING DOCUMENTATION . 45
33 206 Usability . 45
34 Annexes . 46
35 Annex A Annex AA (informative) Particular guidance and rationale . 46
36 Index of defined terms used in this standard . 49
38 Figure A.1 – Signals related to IGRT LATENCY . 46
40 Table 201.101 – Data required in the technical description . 20
SIST EN 60601-2-68:2015/oprA1:2023
62C/876/CDV – 4 – IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023
41 Table 201.102 – Clauses and subclauses in this particular standard that require the provision
42 of information in the ACCOMPANYING DOCUMENTATION, INSTRUCTIONS FOR USE and the technical
43 description . 21
SIST EN 60601-2-68:2015/oprA1:2023
IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023 – 5 – 62C/876/CDV
45 INTERNATIONAL ELECTROTECHNICAL COMMISSION
46 ____________
48 MEDICAL ELECTRICAL EQUIPMENT –
50 Part 2-68: Particular requirements for the basic safety and essential performance
51 of X-ray-based image-guided radiotherapy equipment for use with electron
52 accelerators, light ion beam therapy equipment and radionuclide beam therapy
53 equipment
55 AMENDMENT 1
57 FOREWORD
58 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national
59 electrotechnical committees (IEC National Committees). The object of IEC is to promote international co -operation on all
60 questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities,
61 IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS)
62 and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC
63 National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental
64 and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with
65 the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between
66 the two organizations.
67 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus
68 of opinion on the relevant subjects since each technical committee has representation from all interested IEC National
69 Committees.
70 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in
71 that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC
72 cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
73 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to
74 the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and
75 the corresponding national or regional publication shall be clearly indicated in the latter.
76 5) IEC itself does not provide any attestation of conformity. Independent certificatio n bodies provide conformity assessment
77 services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by
78 independent certification bodies.
79 6) All users should ensure that they have the latest edition of this publication.
80 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of
81 its technical committees and IEC National Committees for any personal injury, property damage or other damage of any
82 nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publicatio n,
83 use of, or reliance upon, this IEC Publication or any other IEC Publications.
84 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable
85 for the correct application of this publication.
86 9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). IEC
87 takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the
88 date of publication of this document, IEC had not received notice of (a) patent(s), which may be required to implement this
89 document. However, implementers are cautioned that this may not represent the latest information, which may be obtained
90 from the patent database available at https://patents.iec.ch [and/or] www.iso.org/patents. IEC shall not be held responsible
91 for identifying any or all such patent rights.
92 Amendment 1 to IEC 60601-2-68:2014 has been prepared by subcommittee SC 62: Equipment for
93 radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee TC 62: Medical
94 equipment, software, and systems.
SIST EN 60601-2-68:2015/oprA1:2023
62C/876/CDV – 6 – IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023
95 The text of this Amendment is based on the following documents:
Draft Report on voting
XX/XX/XXXX XX/XX/XXX
97 Full information on the voting for its approval can be found in the report on voting indicated in the above
98 table.
99 The language used for the development of this Amendment is English.
100 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in accordance
101 with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available at
102 www.iec.ch/members_experts/refdocs. The main document types developed by IEC are described in
103 greater detail at www.iec.ch/publications/.
104 The committee has decided that the contents of this document will remain unchanged until the stability
105 date indicated on the IEC website under webstore.iec.ch in the data related to the specific document.
106 At this date, the document will be
107 • reconfirmed,
108 • withdrawn,
109 • replaced by a revised edition, or
110 • amended.
SIST EN 60601-2-68:2015/oprA1:2023
IEC CDV 60601-2-68:2014/AMD 1 © IEC 2023 – 7 – 62C/876/CDV
112 INTRODUCTION to Amendment 1
113 Since the publication of IEC 60601-2-6
...
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