EN 60601-2-64:2015/prA1:2024
(Main)Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-Bestrahlungseinrichtungen
Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers
Medicinska električna oprema - 2-64. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinske opreme za lahkoionsko terapijo - Dopolnilo A1
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Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2024
Medicinska električna oprema - 2-64. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinske opreme za lahkoionsko terapijo - Dopolnilo A1
Amendment 1 - Medical electrical equipment - Part 2-64: Particular requirements for the
basic safety and essential performance of light ion beam medical electrical equipment
Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Leichtionen-
Bestrahlungseinrichtungen
Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils électromédicaux par faisceau d'ions
légers
Ta slovenski standard je istoveten z: EN 60601-2-64:2015/prA1:2024
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62C/905/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-64/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-02-09 2024-05-03
SUPERSEDES DOCUMENTS:
62C/878/CD, 62C/890A/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:
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 Some Countries” clau ses
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 2-64: Particular requirements for the basic safety and
essential performance of light ion beam medical electrical equipment
PROPOSED STABILITY DATE: 2024
NOTE FROM TC/SC OFFICERS:
In the attached CDV, red characters represent changes from Ed1 to AMD1/CD1, blue characters represent
changes from AMD1/CD1 to AMD1/CD2, purple characters represent changes from AMD1/CD2 to AMD1/CDV,
respectively, based on the NCs' comments and discussion in WG 1.
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 permis sion
in writing from IEC.
62C/905/CDV – 2 – IEC 60601-2-64/A1 CDV © IEC 2024
As indicated in 62C/766/Q, the scope of AMD1 is as follows:
1) Harmonization with IEC 60601-1 Ed1/AMD2
2) Harmonization with IEC 62667 (light ion performance) for defined terms
3) Neutrons outside the field of irradiation.
In addition, a correction to the current edition has been prepared for CDV, while any other comments, such as the
introduction of a new concept, are excluded and are expected to be discussed in a future amendment or edition.
IEC 60601-2-64/A1 CDV © IEC 2024 – 3 – 62C/905/CDV
1 CONTENTS
2 CONTENTS . 1
3 FOREWORD . 4
4 INTRODUCTION . 6
5 201.1 Scope, object and related standards . 7
6 201.2 Normative references . 9
7 201.3 Terms and definitions. 10
8 201.4 General requirements . 16
9 201.5 General requirements for testing of ME EQUIPMENT. 17
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
11 201.7 ME EQUIPMENT identification, marking and documents . 18
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 21
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 28
15 201.11 Protection against excessive temperatures and other HAZARDS . 50
16 201.12 Accuracy of controls and instruments and protection against hazardous
17 outputs . 50
18 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 50
19 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 50
20 201.15 Construction of ME EQUIPMENT . 51
21 201.16 ME SYSTEMS . 51
22 201.17 ELECTROMAGNETIC COMPATIBILITYCOMPATIBILITY DISTURBANCES of ME
23 EQUIPMENT and ME SYSTEMS . 52
24 201.101 ELECTRONIC IMAGING DEVICES (EID) . 53
25 201.102 Operation of ME EQUIPMENT parts from outside the facility . 53
26 206 Usability . 54
27 Annexes. 57
28 Annex B (informative) Sequence of testing . 57
29 Annex I (informative) ME SYSTEMS aspects . 57
30 Bibliography . 58
31 Index of defined terms used in this particular standard. 59
34 Figure 201.101 – PATIENT POSITIONERPATIENT SUPPORT movements . 55
35 Figure 201.102 – Diagram illustrating example RADIATION HEAD components and
36 possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 56
37 Figure 201.103 – Diagram illustrating distance along PATIENT plane to measure
38 NON-PRIMARY RADIATION ABSORBED DOSE . 56
40 Table 201.101 – Data required in the technical description to support Clause 201.10
41 SITE TEST compliance . 20
62C/905/CDV – 4 – IEC 60601-2-64/A1 CDV © IEC 2024
44 INTERNATIONAL ELECTROTECHNICAL COMMISSION
45 ____________
47 MEDICAL ELECTRICAL EQUIPMENT –
49 Particular requirements for the basic safety
50 and essential performance of LIGHT ION BEAM ME EQUIPMENT
52 FOREWORD
53 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
54 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
55 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
56 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
57 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
58 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
59 in the subject dealt with may participate in this preparatory work. International, governmental and
60 non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates
61 closely with the International Organization for Standardization (ISO) in accordance with conditions determined
62 by agreement between the two organizations.
63 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
64 consensus of opinion on the relevant subjects since each technical committee has representation from all
65 interested IEC National Committees.
66 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
67 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
68 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
69 misinterpretation by any end user.
70 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
71 transparently to the maximum extent possible in their national and regional publications. Any divergence
72 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
73 the latter.
74 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
75 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
76 services carried out by independent certification bodies.
77 6) All users should ensure that they have the latest edition of this publication.
78 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
79 members of its technical committees and IEC National Committees for any personal injury, property damage or
80 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
81 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
82 Publications.
83 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
84 indispensable for the correct application of this publication.
85 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
86 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
87 International Standard IEC 60601-2-64 has been prepared by subcommittee 62C: Equipment
88 for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
89 Medical equipment, software, and systems.
90 The text of this standard is based on the following documents:
FDIS Report on voting
92 Full information on the voting for the approval of this standard can be found in the report on
93 voting indicated in the above table.
IEC 60601-2-64/A1 CDV © IEC 2024 – 5 – 62C/905/CDV
95 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
96 In this standard, the following print types are used:
97 – Requirements and definitions: roman type.
98 – Test specifications: italic type.
99 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
100 Normative text of tables is also in a smaller type.
101 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
102 NOTED: SMALL CAPITALS.
103 In referring to the structure of this standard, the term
104 – “clause” means one of the numbered divisions within the table of contents, inclusive of all
105 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
106 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
107 subclauses of Clause 7).
108 References to clauses within this standard are preceded by the term “Clause” followed by the
109 clause number. References to subclauses within this particular standard are by number only.
110 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
111 combination of the conditions is true.
112 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
113 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
114 – “shall” means that compliance with a requirement or a test is mandatory for compliance
115 with this standard;
116 – “should” means that compliance with a requirement or a test is recommended but is not
117 mandatory for compliance with this standard;
118 – “may” is used to describe a permissible way to achieve compliance with a requirement or
119 test.
120 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
121 equipment, can be found on the IEC website.
122 The committee h
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