FprEN IEC 60601-2-64:2025

SLOVENSKI STANDARD
SIST EN 60601-2-64:2015/oprA1:2024
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
SIST EN 60601-2-64:2015/oprA1:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN 60601-2-64:2015/oprA1:2024

SIST EN 60601-2-64:2015/oprA1:2024
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.
SIST EN 60601-2-64:2015/oprA1:2024
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.

SIST EN 60601-2-64:2015/oprA1:2024
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
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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.
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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 has decided that the contents of this publication will remain unchanged until
123 the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
124 related to the specific publication. At this date, the publication will be
125 • reconfirmed,
126 • withdrawn,
127 • replaced by a revised edition, or
128 • amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
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133 INTRODUCTION
134 The use of LIGHT ION BEAM ME EQUIPMENT for RADIOTHERAPY purposes may expose PATIENTS to
135 danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME
136 EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The ME
137 EQUIPMENT may also cause danger to persons in the vicinity if the ME EQUIPMENT itself fails to
138 contain the RADIATION adequately or if there are inadequacies in the design of the TREATMENT
139 ROOM.
140 This particular standard establishes requirements to be complied with by MANUFACTURERS in
141 the design and construction of LIGHT ION BEAM ME EQUIPMENT for use in RADIOTHERAPY; it does
142 not attempt to define their optimum performance requirements. Its purpose is to identify those
143 features of design that are regarded, at the present time, as essential for the safe operation of
144 such ME EQUIPMENT; it places limits on the degradation of ME EQUIPMENT performance beyond
145 which it can be presumed that a fault condition exists and where an INTERLOCK then operates
146 to prevent continued operation of the ME EQUIPMENT.
147 Clause 201.10 contains limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE
148 IRRADIATION in order to insure that ESSENTIAL PERFORMANCE is maintained and to avoid an
149 unsafe condition. TYPE TESTS that are performed by the MANUFACTURER, or SITE TESTS, which
150 are not necessarily performed by the MANUFACTURER, are SPECIFIED for each requirement. It
151 should be understood that, before installation, a MANUFACTURER can provide a compliance
152 certificate relating only to TYPE TESTS. Data available from SITE TESTS should be incorporated
153 in the ACCOMPANYING DOCUMENTS, in the form of a SITE TEST report, by those who test the ME
154 EQUIPMENT at installation.
155 Closely related to this standard is IEC 62667 which is currently being developed. It specifies
156 test methods and reporting formats for performance tests of LIGHT ION BEAM ME EQUIPMENT for
157 use in RADIOTHERAPY, with the aim of providing uniform methods of doing so. The annex of
158 IEC 62667 provides forms for presenting performance values, measured per the methods
159 SPECIFIED.
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161 MEDICAL ELECTRICAL EQUIPMENT –
163 Particular requirements for the basic safety
164 and essential performance of LIGHT ION BEAM ME EQUIPMENT
168 201.1 Scope, object and related standards
169 Clause 1 of the general standard applies, except as follows:
170 201.1.1 Scope
171 Replacement:
172 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT
173 ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.
174 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
175 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
176 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
177 This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively
178 to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT
179 – intended for RADIOTHERAPY in human medical practice, including those in which the
180 selection and DISPLAY of operating parameters can be controlled automatically by
181 PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
182 – that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in
183 the range 10 MeV/n to 500 MeV/n,
184 and
185 – intended to be
186 – for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED
187 PERSONS by OPERATORS having the required skills for a particular medical application,
188 for particular SPECIFIED clinical purposes maintained in accordance with the
189 recommendations given in the INSTRUCTIONS FOR USE,
190 – subject to regular quality assurance performance and calibration checks by a QUALIFIED
191 PERSON.
192 NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE
193 ORGANIZATION’S premises.
194 NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
195 NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).
196 NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their
197 zero positions and the direction of movement with increasing value (see 201.7.4.101).
198 201.1.2 Object
199 Replacement:
____________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012/AMD2:2020, Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance

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200 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
201 PERFORMANCE requirements for LIGHT ION BEAM ME EQUIPMENT in the range 10 MeV/n to
202 500 MeV/n and to SPECIFY tests to check compliance to those requirements.
203 NOTE The adoption of this standard helps to ensure that the ME EQUIPMENT
204 – maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS;
205 – delivers the pre-selected RADIATION TYPE, ENERGY PER NUCLEON, LIGHT ION species, and ABSORBED DOSE;
206 – delivers pre-selected LIGHT ION BEAMS to the PATIENT, by utilizing LIGHT ION BEAM modifying devices, etc.,
207 without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.
208 201.1.3 Collateral standards
209 Addition:
210 Collateral standards published after the date of publication of this standard shall only apply
211 subject to further amendment to this standard.
212 This particular standard refers to those applicable collateral standards that are listed in
213 Clause 2 of the general standard and Clause 201.2 of this particular standard.
214 IEC 60601-1-6 applies as modified in Clause 206. IEC 60601-1-3, IEC 60601-1-8,
2 3
215 IEC 60601-1-9 and IEC 60601-1-10 do not apply. All other published collateral standards in
216 the IEC 60601-1 series apply as published.
217 NOTE Collateral standards published after the date of publication of this standard will only apply subject to further
218 amendment to this standard.
219 201.1.4 Particular standards
220 Replacement:
221 In the IEC 60601 series, particular standards may modify, replace or delete requirements
222 contained in the general standard or collateral standards as appropriate for the particular
223 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
224 PERFORMANCE requirements.
225 A requirement of a particular standard takes priority over the general standard.
226 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
227 Collateral standards are referred to by their document number.
228 The numbering of clauses and subclauses of this particular standard corresponds to that of
229 the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
230 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
231 where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
232 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
233 standard, 203.4 in this particular standard addresses the content of Clause 4 of the
234 IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
235 specified by the use of the following words:
236 “Replacement” means that the clause or subclause of the general standard or applicable
237 collateral standard is replaced completely by the text of this particular standard.
____________
IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

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238 “Addition” means that the text of this particular standard is additional to the requirements of
239 the general standard or applicable collateral standard.
240 “Amendment” means that the clause or subclause of the general standard or applicable
241 collateral standard is amended as indicated by the text of this particular standard.
242 Subclauses, figures or tables which are additional to those of the general standard are
243 numbered starting from 201.101. However due to the fact that definitions in the general
244 standard are numbered 3.1 through 3.139, additional definitions in this standard are
245 numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
246 additional items aa), bb), etc.
247 Subclauses, figures or tables which are additional to those of a collateral standard are
248 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
249 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
250 The term “this standard” is used to make reference to the general standard, any applicable
251 collateral standards and this particular standard taken together.
252 Where there is no corresponding clause or subclause in this particular standard, the clause or
253 subclause of the general standard or applicable collateral standard, although possibly not
254 relevant, applies without modification; where it is intended that any part of the general
255 standard or applicable collateral standard, although possibly relevant, is not to be applied, a
256 statement to that effect is given in this particular standard.
257 201.2 Normative references
258 Clause 2 of the general standard applies, except as follows:
259 Replacement:
260 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
261 safety and essential performance – Collateral Standard: Electromagnetic disturbances –
262 Requirements and tests
263 IEC 60601-1-2:2014/AMD1:2020
264 Addition:
265 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
266 safety and essential performance
267 IEC 60601-1:2005/AMD1:2012
268 IEC 60601-1:2005/AMD2:2020
269 IEC 60601-2-1:20092020, Medical electrical equipment – Part 2-1: Particular requirements for
270 the basic safety and essential performance of electron accelerators in the range 1 MeV to 50
271 MeV
272 IEC 60601-2-11:2013, Medical electrical equipment – Part 2-11: Particular requirements for
273 the basic safety and essential performance of gamma beam therapy equipment
274 IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
275 IEC 61217:2011, Radiotherapy equipment – Coordinates, movements and scales
276 ISO/IEC 14165-321:2009, Information technology – Fibre channel – Part 321: Audio video
277 (FC-AV)
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278 NOTE Informative references are listed in the bibliography.
279 201.3 Terms and definitions
280 For the purposes of this document, the terms and definitions given in
281 IEC 60601-1:2005/AMD1:2012/AMD2:2020+A1:2012, IEC 60601-2-1:20092020, and
282 IEC TR 60788:2004 apply, except as follows:
283 Additional definitions:
284 201.3.201
285 APPLICATOR CARRIAGE
286 the most distal part of the RADIATION HEAD that can not be removed without using tools to
287 which interchangeable LIGHT ION BEAM APPLICATORS are attached and which may extend
288 toward and retract away from the ISOCENTRE or ERP.
289 Note 1 to entry: Colloquially the APPLICATOR CARRIAGE has sometimes been called a snout.
290 201.3.202
291 BEAM FLUENCE DISTRIBUTION MONITOR
292 system to monitor directly or indirectly the FLUENCE distribution of the beam to provide beam
293 steering or lateral spreading information
294 Note 1 to entry: This monitor may be used as a surrogate monitor for the DOSE distribution delivered to the
295 patient.
296 Note 2 to entry: Examples of BEAM FLUENCE DISTRIBUTION MONITORS include quadrant foil ionization chambers,
297 concentric ring ionization chambers, multi-strip ionization chambers, scintillator plates, and scanning magnet field
298 probes.
299 201.3.203
300 BEAM FLUX MONITOR
301 system to monitor the FLUX of the beam
302 Note 1 to entry: This monitor may be used as a surrogate monitor for the DOSE rate delivered to the patient.
303 201.3.204
304 BEAM GATING
305 allowance or inhibition of IRRADIATION and related equipment movements according to the
306 status provided by a BEAM GATING SIGNAL
307 201.3.205
308 BEAM GATING SIGNAL
309 signal generated for the purpose of BEAM GATING
310 EXAMPLE Examples include a respiratory spirometer, electrocardiogram, optical sensor, etc.
311 201.3.206
312 CONTROLLING TIMER
313 device to measure the time during which IRRADIATION occurs and, if a predetermined time is
314 reached, to TERMINATE IRRADIATION
315 [SOURCE: IEC 60601-2-1: 20092020, 201.3.202210]
316 201.3.207
317 DOSE MONITOR UNIT
318 a parameter, reported by the DOSE MONITORING SYSTEM, from which, through a calibration
319 procedure and with additional information, the ABSORBED DOSE delivered can be calculated

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320 201.3.208
321 DOSE MONITOR UNIT RATE
322 DOSE MONITOR UNIT per unit time
323 201.3.209
324 DOSE MONITOR UNIT RATE MONITORING SYSTEM
325 system of devices for the measurement and DISPLAY of a radiation quantity related to DOSE
326 MONITOR UNIT RATE
327 201.3.210
328 DOSE MONITORING SYSTEM
329 system of devices for the measurement and DISPLAY of a radiation quantity related to the
330 ABSORBED DOSE
331 201.3.211
332 ENERGY PER NUCLEON
333 the total kinetic energy of the ion divided by the number of nucleons in the nucleus at the
334 point where the ion enters the RADIATION HEAD before passing through any beam modifiers
335 201.3.212
336 EQUIPMENT REFERENCE POINT
337 ERP
338 point in space used for referencing dimensions of equipment and performing dosimetry
339 measurements
340 Note 1 to entry: Typically the reference point is coincident with the ISOCENTRE. If the beam delivery equipment is
341 not ISOCENTRIC, then the centre of the PATIENT alignment systems may be used.
342 Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation " ERP" stands for
343 "EQUIPMENT REFERENCE POINT" in English.
344 201.3.213
345 FLUENCE
346 particles per unit areathe quotient of dN by dAa, where dN is the number of particles incident on a
347 sphere of cross-sectional area dAa, thus
348 Φ = dN/dA
349 Note 1 to entry: Definition from See ICRU 33ICRU 85a.
350 201.3.214
351 FLUX
352 particles per unit time
353 Note 1 to entry: See ICRU 33, ICRU 85a.
354 the quotient of dN by dt, where dN is the increment of the particle number in the time interval dt, thus
.
355 N = dN/dt
356 Note 1 to entry: Definition from ICRU 85a.
357 201.3.215
358 HARD-WIRED
359 term used where the features of a system can be modified only by physically removing and
360 re-routing wires
361 [SOURCE: IEC 60601-2-1: 20092020, 201.3.208224]

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362 201.3.216
363 INTERRUPTION OF IRRADIATION
364 TO INTERRUPT IRRADIATION
365 stopping of/to stop IRRADIATION and movements with the possibility of continuing without
366 reselecting operating conditions
367 [SOURCE: IEC 60601-2-1: 20092020, 201.3.210227]
368 201.3.217
369 LATERAL SPREADING DEVICE
370 LSD
371 device used to increase the lateral (Xxg, Yyg) (x , y ) dimensions of a small diameter LIGHT
b b
372 ION BEAM produced by an accelerator
373 EXAMPLE Examples of spreading devices include a thin metal foil for scattering the ions or a magnet to defocus
374 the beam or to scan the beam laterally across the intended target volumeTARGET VOLUME.
375 Note 1 to entry: Xg and Yg are defined in IEC 61217:2011.The definition was taken from IEC 60601-2-64:2014 but further
376 review after publication of the standard showed that the GANTRY frame of reference would be more appropriate.
377 201.3.218
378 LIGHT ION
379 species of ion with an atomic number less than or equal to that of neon ( Z  10) and SPECIFIED
380 by its number of protons, number of nucleons and ionization state
381 201.3.219
382 LIGHT ION BEAM
383 collection of LIGHT IONS travelling in the same general direction
384 201.3.220
385 LIGHT ION BEAM APPLICATOR
386 device for holding a BEAM LIMITING DEVICE or ACCESSORY close to the PATIENT's skin during
387 delivery of LIGHT ION BEAM
388 Note 1 to entry: Several LIGHT ION BEAM APPLICATORS may be available to reduce the weight of APERTURES lifted
389 by the OPERATORtherapists, decrease the ACCESSORYbolus to skin distance and reduce leakage radiation.
390 Note 2 to entry: ACCESSORIES that may be held by the LIGHT ION BEAM APPLICATOR include but are not limited to
391 range shiftersRANGE SHIFTERs, alignment cross-wires, ridge filters, mirror or camera for viewing the PATIENT,
392 beam monitor.
393 201.3.221
394 LIGHT ION BEAM DISTRIBUTION SYSTEM
395 system of components and a control system used to transport the RADIATION from a RADIATION
396 SOURCE to several TREATMENT stations, experimental stations or beam dumps
397 EXAMPLE Examples of components include vacuum pipes, magnets, and steering coils.
398 201.3.222
399 LIGHT ION RANGE
400 the depth in a PHANTOM most distant from its surface at which the ABSORBED DOSE is a
401 SPECIFIED value, given in the ACCOMPANYING DOCUMENTS, of the dose at the nominal
402 centre-of-modulation depth or of the dose maximum for a non-range-modulated beam, which
403 is measured on the RADIATION BEAM AXIS in a SPECIFIED RADIATION FIELD and with the surface of
404 the PHANTOM at a SPECIFIED distance from the ERP without RANGE SHIFTERS or ACCESSORIES
405 installed in the RADIATION HEAD downstream of the ENERGY PER NUCLEON or range monitoring
406 system
SIST EN 60601-2-64:2015/oprA1:2024
IEC 60601-2-64/A1 CDV © IEC 2024 – 13 –  62C/905/CDV
407 201.3.223
408 MODULATED SCANNING
409 SCANNING MODE wherein a small diameter LIGHT ION BEAM is scanned across a target to create
410 a field large enough to cover the target such that the intended FLUENCE delivered to the
411 PATIENT is different at different lateral locations
412 Note 1 to entry: Various spatial and temporal scanning patterns may be used to generate the modulated FLUENCE
413 distribution.
414 201.3.224
415 NON-PRIMARY RADIATION
416 RADIATION emitted from the LIGHT ION BEAM ME EQUIPMENT that is not intended to treat the
417 PATIENT
418 201.3.225
419 NORMAL USE
420 operation, including routine inspection and adjustments by the OPERATOR, and STAND-BY,
421 according to the instructions for use
422 Note 1 to entry: NORMAL USE includes PATIENT TREATMENT, equipment calibration, quality assurance procedures,
423 maintenance, normal maintenance and other procedures performed by the OPERATOR required in preparation for
424 PATIENT TREATMENTS.
425 [SOURCE: IEC TR 60788:2004, NG, 10.08, modified – A note to entry has been added.]
426 IEC60601-1:
427 operation, including routine inspection and adjustments by any operator, and stand -by,
428 according to the instructions for use
429 NOTE Normal use should not be confused with intended use. While both include the concept of use as intended by
430 the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the
431 medical purpose, but maintenance, transport, etc. as well.
433 201.3.225
434 PATIENT SUPPORT PATIENT POSITIONER
435 assembly of equipment upon which the PATIENT is placed and positioned for
436 RADIOTHERAPYassembly of ME EQUIPMENT that supports the PATIENT
437 Note 1 to entry: The PATIENT POSITIONER includes the TABLE TOP and TABLE TOP SUPPORT.
438 [SOURCE: IEC TR 60601-2-1:20092020, 201.3.215235]
439 201.3.226
440 PORTAL
441 collection of one or more pre-programmed TREATMENT segments treated automatically with a
442 single PATIENT set-up
443 Note 1 to entry: Segments may consist of treatment beam IRRADIATION, motion of devices, or imaging.
444 201.3.227
445 PRE-PROGRAMMED MOVEMENTS
446 movement of ME EQUIPMENT parts that takes place according to a previously planned
447 programme without intervention by the OPERATOR during a PATIENT treatment or imaging
448 201.3.228
449 PRIMARY/SECONDARY DOSE MONITORING COMBINATION
450 utilization of two DOSE MONITORING SYSTEMS where one is arranged to be the PRIMARY and the
451 other the SECONDARY DOSE MONITORING SYSTEM

SIST EN 60601-2-64:2015/oprA1:2024
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452 201.3.229
453 PROGRAMMABLE RANGE MODULATED PORTAL
454 PRMP
455 a LIGHT ION PORTAL in which a RANGE MODULATION DEVICE or program is used, with or without a
456 RANGE MODULATION DEVICE (RMD), to tailor the DEPTH DOSE distribution by varying the
457 penetration and weighting factors of several component segments
458 Note 1 to entry: Typically the DEPTH DOSE distribution is tailored to give a uniform dose distribution over the
459 depths where the TARGET VOLUMEtarget (tumour) resides.
460 Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation " PRMP" stands
461 for "PROGRAMMABLE RANGE MODULATED PORTAL" in English.
462 201.3.230
463 QUALITY FACTOR, Q
464 The quality factor at a point in tissue, is given by:
466 where D is the absorbed dose at that point, DL is the distribution of D in unrestricted linear
467 energy transfer L at the point of interest, and Q(L) is the quality factor as a function of L. The
468 integration is to be performed over DL, due to all charged particles, excluding their secondary
469 electrons.
470 [SOURCE: ICRP Publication 116]
471 201.3.231
472 RADIATION HEAD
473 structure from which the RADIATION BEAM emerges
474 [SOURCE: IEC TR 60788:2004, rm-20-06]
475 201.3.233
476 RANGE MODULATED PORTAL
477 RMP
478 LIGHT ION PORTAL in which a RANGE MODULATION DEVICE or program is used to tailor
479 the DEPTH DOSE distribution
480 201.3.233
481 RANGE MODULATION
482 60 mm in NRMW of range modulation
483 201.3.232
484 RANGE MODULATION DEVICE
485 RMD
486 device used to modulate the penetration of a RADIATION BEAMbeam into a PATIENT to tailor the
487 DEPTH DOSE distribution during the delivery of one PORTAL
488 Note 1 to entry: The device may consist of a propellor shaped material that spins in the beam, a filter containing a
489 repeating pattern of metallic ridges (e.g. ridge filter, mini-ridge filter, ripple filter), a cone or set of cones, or a set of
490 uniform thickness blocks programmable in a binary fashion. Sub-types include discrete and programmable.
491 Note 2 to entry: The corresponding note to entry in the French text indicates that the abbreviation " RMD" stands
492 for "RANGE MODULATION DEVICE" in English.
493 201.3.233
494 RANGE SHIFTER
495 range modifying device that has a constant thickness at all positions lateral to the central axis
496 of the beam
SIST EN 60601-2-64:2015/oprA1:2024
IEC 60601-2-64/A1 CDV © IEC 2024 – 15 –  62C/905/CDV
497 201.3.234
498 REDUNDANT DOSE MONITORING COMBINATION
499 utilization of two DOSE MONITORING SYSTEMS where both systems are arranged to TERMINATE
500 IRRADIATION according to the pre-selected number of DOSE MONITOR UNITS
501 201.3.235
502 SCANNING MODE
503 method of delivering a scanned RADIATION BEAMbeam to generate a laterally broad field
504 Note 1 to entry: Types of SCANNING MODES include: none, UNIFORM SCANNING and and or MODULATED SCANNING.
505 201.3.236
506 SITE TEST
507 after installation, test of an individual device or ME EQUIPMENT to establish compliance with
508 SPECIFIED criteria
509 Note 1 to entry: It is understood that SITE TESTS shall be performed but may or may not be performed by the
510 MANUFACTURER, per the agreement between the MANUFACTURER and the end USER.
511 [SOURCE: IEC 60601-2-1:20092020, 201.3.221253, modified – The note to entry has been
512 added.]
513 201.3.237
514 TABLE TOP
515 an exchangeable device attached to the patient positioner to which registration and immobilization
516 devices are attached and upon which the patient is placed.
517 device attached to the PATIENT SUPPORT PATIENT POSITIONERTABLE TOP SUPPORT to which
518 registration orand immobilization devices are attached and upon which the PATIENT is placed
520 Note 1 to entry: TABLE TOPS are often exchangeable to hold PATIENTS or equipment in different orientations, for instance a flat
521 board or a chair mounted onto PATIENT POSITIONER.
523 [SOURCE: IEC 60601-2-1:2020, 201.3.254 modified – Note 1 replaced.]
525 201.3.238
526 TABLE TOP SUPPORT
527 device used in conjunction with the TABLE TOP to support and position the PATIENT during
528 RADIOTHERAPY
529 [SOURCE: IEC 60601-2-1:2020, 201.3.255]
530 201.3.239
531 TECHNICAL DOCUMENTATION
532 documentation that enables the conformity of the product with the requirements of the
533 standard(s) to be assessed
534 Note 1 to entry: This may include schedule drawings when a certification body is involved.
535 Note 2 to entry: It covers the design, manufacture and operation of the product and may contain:
536 – a general description;
537 – design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
538 – descriptions and explanations necessary for the understanding of drawings and layouts and the operation of
539 the product;
540 – a list of the standards referred to in the Ex certificateCERTIFICATE, applied in full or in part, and descriptions of
541 the solutions adopted to meet the requirements of the standards;
542 – results of design calculations made, examinations carried out, etc.;
543 – test reports
544 Note 3 to entry: The technical description includes information derived from the TECHNICAL DOCUMENTATION.

SIST EN 60601-2-64:2015/oprA1:2024
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545 [SOURCE: ISO/IEC 80079-34:20112018, 3.12, modified – A third note to entry has been
546 added.]
547 201.3.240
548 TERMINATION OF IRRADIATION
549 TERMINATE IRRADIATION
550 stopping of/to stop IRRADIATION and movements, with no possibility of restarting without
551 returning to the PREPARATORY STATE
552 Note 1 to entry: Examples of events that may TERMINATE IRRADIATION and stop movements include:
553 – when the pre-selected value of DOSE MONITOR UNITS is reached,
554 – when the pre-selected value is reached in the termination system independent of the DOSE MONITORING
555 SYSTEM,
556 – by a deliberate manual act,
557 – by the operation of an INTERLOCK, or
558 – in MODULATED SCANNING, when pre-programmed scanning pattern is completed
559 [SOURCE: IEC 60601-2-11:2013, 201.3.225, modified – The wording of both the definition
560 and the note to entry is slightly different.]
561 201.3.241
562 TRANSMISSION DETECTOR
563 RADIATION DETECTOR through which the LIGHT ION BEAM passes
564 [SOURCE: IEC 60601-2-1:20092020, 201.3.226257, modified – The term "RADIATION BEAM"
565 has been replaced by "LIGHT ION BEAM".]
566 201.3.242
567 TYPE TEST
568 test on a representative sample of the equipment with the objective of determining if the
569 equipment, as designed and manufactured, can meet the requirements of this
570 documentstandard.
571 [SOURCE: IEC 60601-1:2005/AMD1:2012/AMD2:2020, 3.135]
572 201.3.243
573 UNIFORM SCANNING
574 SCANNING MODE wherein a RADIATION BEAM is scanned laterally in a pre-defined pattern to
575 produce a field large enough to treat the target such that the FLUX of the RADIATION BEAMbeam
576 is not intentionally changed throughout the lateral scan so that the resultant dose distribution
...