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
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
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
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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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