oSIST prEN IEC 60601-2-92:2026

SLOVENSKI STANDARD
01-april-2026
Medicinska električna oprema - 2-92. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za radioterapijo z magnetno resonanco, ki se uporablja
z opremo za zunanje obsevanje
Medical electrical equipment - Part 2-92: Particular requirements for the basic safety and
essential performance of magnetic resonance guided radiotherapy equipment for use
with external beam equipment
Ta slovenski standard je istoveten z: prEN IEC 60601-2-92:2026
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62C/972/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-92 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2026-02-13 2026-05-08
SUPERSEDES DOCUMENTS:
62C/918/CD, 62C/933A/CC
IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):
SC 62B
ASPECTS CONCERNED:
Safety
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
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clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Medical electrical equipment - Part 2-92: Particular requirements for the basic safety and essential
performance of magnetic resonance guided radiotherapy equipment for use with external beam
equipment
PROPOSED STABILITY DATE: 2030
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NOTE FROM TC/SC OFFICERS:
IEC CDV 60601-2-92 © IEC 2026
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 2
4 INTRODUCTION . 5
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 . 13
9 201.5 General requirements for testing ME EQUIPMENT . 13
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
11 201.7 ME EQUIPMENT identification, marking and documents . 14
12 202 Protection against electrical HAZARDS from ME EQUIPMENT . 20
13 203 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
14 204 Protection against unwanted and excessive radiation HAZARDS . 23
15 205 Protection against excessive temperatures and other HAZARDS . 23
16 206 Accuracy of controls and instruments and protection against hazardous outputs . 23
17 207 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
18 208 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
19 209 Construction of ME EQUIPMENT . 24
20 210 ME SYSTEMS . 24
21 211 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
22 201.101 Reference data for GUIDED RADIOTHERAPY . 25
23 201.102 GUIDED RADIOTHERAPY acquisition . 28
24 201.103 GUIDED RADIOTHERAPY Analysis and correction . 30
25 202 Electromagnetic compatibility – Requirements and tests . 34
26 206 Usability . 34
27 Annexes . 35
28 Annex B (informative) Sequence of testing. 35
29 Annex I (informative) ME SYSTEMS aspects . 35
30 Annex AA (informative) Particular guidance and rationale . 36
31 Annex BB (normative) . 38
32 Bibliography . 38
33 Index of defined terms . 39
35 Figure A. 1 Signals related to GRT LATENCY . 38
37 Table 201.101 – Data required in the technical description . 17
38 Table 201.102 – Clauses and subclauses in this particular standard that require the
39 provision of information in the ACCOMPANYING INFORMATION, INSTRUCTIONS FOR USE and
40 the technical description . 18
IEC CDV 60601-2-92 © IEC 2026
42 INTERNATIONAL ELECTROTECHNICAL COMMISSION
43 ____________
45 MEDICAL ELECTRICAL EQUIPMENT –
47 Part 2-92: Particular requirements for the basic safety and essential
48 performance of magnetic resonance guided radiotherapy equipment
49 for use with external beam equipment
51 FOREWORD
52 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
53 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
54 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
55 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
56 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
57 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
58 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
59 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
60 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
61 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
62 consensus of opinion on the relevant subjects since each technical committee has representation from all
63 interested IEC National Committees.
64 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
65 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
66 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
67 misinterpretation by any end user.
68 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
69 transparently to the maximum extent possible in their national and regional publications. Any divergence between
70 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
71 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
72 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
73 services carried out by independent certification bodies.
74 6) All users should ensure that they have the latest edition of this publication.
75 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
76 members of its technical committees and IEC National Committees for any personal injury, property damage or
77 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
78 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
79 Publications.
80 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
81 indispensable for the correct application of this publication.
82 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
83 rights. IEC shall not be held responsible for identifying any or all such patent rights.
84 International standard IEC 60601-2-92 has been prepared by IEC subcommittee 62C
85 Equipment for radiotherapy, nuclear medicine and radiation dosimetry of IEC technical
86 committee 62: Medical equipment, software, and systems.
87 The text of this particular standard is based on the following documents:
Draft Report on voting
89 Full information on the voting for its approval can be found in the report on voting indicated in
90 the above table.
IEC CDV 60601-2-92 © IEC 2026
92 The language used for the development of this International Standard is English.
93 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
94 accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
95 at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
96 described in greater detail at www.iec.ch/standardsdev/publications.
97 In this document, the following print types are used:
98 – requirements and definitions: roman type;
99 – test specifications: italic type;
100 – informative material appearing outside of tables, such as notes, examples and references: in smaller type.
101 Normative text of tables is also in a smaller type;
102 – TERMS DEFINED in Clause 3 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
103 IEC 60601-1:2005/AMD2:2020, in this document or as noted: SMALL CAPITALS.
104 In referring to the structure of this document, the term
105 – "clause" means one of the seventeen numbered divisions within the table of contents,
106 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
107 – "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
108 subclauses of Clause 7).
109 References to clauses within this document are preceded by the term "Clause" followed by the
110 clause number. References to subclauses within this document are by number only.
111 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
112 combination of the conditions is true.
113 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
114 Directives, Part 2. For the purposes of this document, the auxiliary verb:
115 – "shall" means that compliance with a requirement or a test is mandatory for compliance with
116 this document;
117 – "should" means that compliance with a requirement or a test is recommended but is not
118 mandatory for compliance with this document;
119 – "may" is used to describe a permissible way to achieve compliance with a requirement or
120 test.
121 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
122 indicates that there is guidance or rationale related to that item in Annex AA.
123 A list of all parts of the IEC 60601 and IEC 80601 series, published under the general title
124 Medical electrical equipment, can be found on the IEC website.
125 The committee has decided that the contents of this document will remain unchanged until the
126 stability date indicated on the IEC website under webstore.iec.ch in the data related to the
127 specific document. At this date, the document will be
128 • reconfirmed,
129 • withdrawn,
130 • replaced by a revised edition, or
131 • amended.
IEC CDV 60601-2-92 © IEC 2026
IMPORTANT – The "colour inside" logo on the cover page of this document 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.
IEC CDV 60601-2-92 © IEC 2026
134 INTRODUCTION
135 Modern RADIOTHERAPY practices utilize information from various imaging modalities, acquired
136 prior to initiating administration of the therapy, to plan the TREATMENT. The imaging provides
137 information about the location of the TARGET VOLUME and other anatomical features so that a
138 TREATMENT PLAN can be developed that provides an optimal dose distribution to have the best
139 chance of achieving the intended effect of TREATMENT while minimizing side effects.
140 However, difficulties arise when trying to administer the RADIATION, since TARGET
141 VOLUMES/critical structures are constantly moving within the body. For example, in parts of the
142 body moving with respiration, the TARGET VOLUMEs/critical structures can change position or
143 shape during the RADIATION BEAM delivery throughout any given fraction. Furthermore, a course
144 of therapy can extend over many days, during which the TARGET VOLUME/PATIENT can shrink,
145 grow or move. Hence, the exact location of the TARGET VOLUME/critical structures can change
146 between the time of TREATMENT planning imaging and the actual administration of a TREATMENT.
147 IMAGE GUIDED RADIOTHERAPY (IGRT) combines imaging during the course of RADIOTHERAPY to
148 adjust the TREATMENT delivery based on the PATIENT anatomy and PATIENT position. Guided
149 Radiotherapy (GRT) encompasses IGRT and includes other non-imaging technologies for precise
150 position of TREATMENT. When magnetic resonance is used for guidance, this is known as MR
151 GUIDED RADIOTHERAPY (MRGRT). This process enables the OPERATOR or EXTERNAL BEAM
152 EQUIPMENT (EBE) to adjust the RADIATION BEAM delivery based on the information from the MRGRT
153 EQUIPMENT, such as the position of the TARGET VOLUME, critical organs or other reference
154 features, to compensate for anatomical changes including internal organ motions or TREATMENT
155 setup uncertainties. The increased accuracy and precision achieved allows higher doses of
156 RADIATION to be delivered to the TARGET VOLUME and a reduction in the margin of healthy cells
157 affected by the RADIATION. This is often used in conjunction with other monitoring equipment.
158 This particular standard establishes requirements to be complied with by MANUFACTURERS in the
159 design and construction of MRGRT EQUIPMENT.
160 When performing a HAZARD ANALYSIS, the MANUFACTURER should consider relevant diagnostic
161 standards. For example, IMAGE DISPLAY DEVICE quality is specified in IEC documents in regard
162 to diagnostic use (e.g., IEC 62563-1, ed. 1.0 (2009-12)). However, since GRT usage does not
163 necessarily have image display requirements, it is left to the MANUFACTURER to specify what is
164 required for use with their MRGRT EQUIPMENT.
165 This particular standard deals with the safety aspects of MRGRT EQUIPMENT relating to alignment
166 of reference frames between EBE and MR, geometric integrity of MR imaging, adapt to position,
167 real time tracking / motion monitoring, and MR image quality for GRT.
168 MRGRT EQUIPMENT is also related to the following current standards:
169 – IEC 60601-2-1, Medical electrical equipment – Part 2-1: Particular requirements for the
170 basic safety and essential performance of electron accelerators in the range 1 MeV to 50
171 MeV
172 – IEC 60601-2-68. Medical Electrical equipment - Part 2-68: Particular requirements for the
173 basic safety and essential performance of X-ray-based image-guided radiotherapy
174 equipment for use with electron accelerators, light ion beam therapy equipment and
175 radionuclide beam therapy equipment
176 – IEC 62083, Medical electrical equipment – Requirements for the safety of radiotherapy
177 treatment planning system
178 – IEC 61217, Radiotherapy equipment – Coordinate movements and scales
179 – IEC 62274, Medical electrical equipment – Safety of radiotherapy record and verify systems
180 – IEC 60601-2-33:2022 Particular requirements for the basic safety and essential
181 performance of magnetic resonance equipment for medical diagnosis
IEC CDV 60601-2-92 © IEC 2026
182 – ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients
183 with an active implantable medical device
184 – IEC TR 62926, Medical electrical system – Guidelines for safe integration and operation of
185 adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy
IEC CDV 60601-2-92 © IEC 2026
187 MEDICAL ELECTRICAL EQUIPMENT –
189 Part 2-92: Particular requirements for basic safety and essential
190 performance of magnetic resonance guided radiotherapy equipment for
191 use with external beam equipment
194 201.1 Scope, object and related standards
195 Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
196 IEC 60601-1:2005/AMD2:2020 applies, except as follows:
197 201.1.1 Scope
198 Replacement:
199 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
200 MAGNETIC RESONANCE GUIDED RADIOTHERAPY EQUIPMENT used in radiation therapy for use with
201 EXTERNAL BEAM EQUIPMENT (EBE).
202 This particular standard covers safety aspects of MR EQUIPMENT in a known geometrical
203 relationship with EXTERNAL BEAM EQUIPMENT for the purpose of GUIDED RADIOTHERAPY, which is
204 defined as MRGRT EQUIPMENT It covers aspects of communication and relationships between the
205 EXTERNAL BEAM EQUIPMENT and MR EQUIPMENT, attached or not directly attached to but in the
206 same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM
207 EQUIPMENT.
208 This particular standard does not apply to stand alone MR EQUIPMENT, that are not used for
209 MRGRT. However, if an MR EQUIPMENT is used in the same room with an EBE for GRT then this
210 particular standard applies.
211 If a clause or subclause is specifically intended to be applicable to EBE SYSTEMS, the content of
212 that clause or subclause will say so. If that is not the case, the clause or subclause applies only
213 to MRGRT EQUIPMENT.
214 This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively
215 to the MANUFACTURER and some installation aspects of MRGRT SYSTEMS intended to be
216 • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED
217 PERSONS having the required skills for a particular medical application, for particular
218 specified clinical purposes, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
219 • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
220 • subject to regular quality assurance performance and calibration checks by a QUALIFIED
221 PERSON.
222 NOTE In this particular standard, all references to installation refer to installation in the RESPONSIBLE
223 ORGANIZATION’S premises
224 201.1.2 Object
225 Replacement:
226 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
227 PERFORMANCE requirements for MRGRT EQUIPMENT
IEC CDV 60601-2-92 © IEC 2026
228 201.1.3 Collateral standards
229 Addition:
230 This document refers to those applicable collateral standards that are listed in Clause 2 of
231 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
232 Clause 201.2 of this document.
233 IEC 60601-1-6 applies as modified in Clause 206.
234 IEC 60601-2-33:2022 Applies with modifications
235 IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other
236 published collateral standards in the IEC 60601-1 series apply as published.
237 Collateral standards published after the date of publication of this standard shall only apply
238 subject to further amendment to this standard.
239 201.1.4 Particular standards
240 Replacement:
241 In the IEC 60601 series, particular standards may modify, replace or delete requirements
242 contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
243 IEC 60601-1:2005/AMD2:2020 and collateral standards as appropriate for the particular
244 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
245 PERFORMANCE requirements.
246 A requirement of a particular standard takes priority over IEC 60601-1:2005,
247 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
248 The numbering of clauses and subclauses of this particular standard corresponds to that of
249 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
250 prefix "201" (e.g. 201.1 addresses the content of Clause 1 of IEC 60601-1:2005,
251 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) or applicable collateral
252 standard with the prefix "20x.101" where x is the final digit(s) of the collateral standard
253 document number (e.g. 202.4 addresses the content of Clause 4 of the IEC 60601-1-2 collateral
254 standard, 203.4 addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard,
255 etc.). The changes to the text of the IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
256 IEC 60601-1:2005/AMD2:2020 or applicable collateral standard are specified by the use of the
257 following words:
258 "Replacement" means that the clause or subclause of IEC 60601-1:2005,
259 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
260 standard is replaced completely by the text of this particular standard.
261 "Addition" means that the text of this particular standard is additional to the requirements of
262 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the
263 applicable collateral standard.
264 "Amendment" means that the clause or subclause of IEC 60601-1:2005,
265 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or the applicable collateral
266 standard is amended as indicated by the text of this particular standard.
267 Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
268 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
269 201.101. However, due to the fact that definitions in IEC 60601-1:2005,
270 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
IEC CDV 60601-2-92 © IEC 2026
271 3.154, additional definitions are numbered beginning from 201.3.201. Additional annexes are
272 lettered AA, BB, etc., and additional items aa), bb), etc.
273 Subclauses, figures or tables which are additional to those of a collateral standard are
274 numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
275 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
276 Where there is no corresponding clause or subclause in this particular standard, the clause or
277 subclause of the IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
278 IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant,
279 applies without modification; where it is intended that any part of the IEC 60601-1:2005,
280 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
281 standard, although possibly relevant, is not to be applied, a statement to that effect is given in
282 this particular standard.
283 201.2 Normative references
284 Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020
285 applies except as follows:
286 Replacement:
287 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
288 safety and essential performance – Collateral Standard: Electromagnetic disturbances –
289 Requirements and tests IEC 60601-1-2:2014/AMD1:2020
290 Addition:
291 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
292 safety and essential performance IEC 60601-1:2005/AMD1:2012 and IEC 60601-
293 1:2005/AMD2:2020
294 IEC 60601-2-1:2020, Medical electrical equipment – Part 2-1: Particular requirements for the
295 basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
296 IEC 60601-2-33:2022, Medical electrical equipment – Part 2-33: Particular requirements for the
297 basic safety and essential performance of magnetic resonance equipment for medical diagnosis
298 IEC 60601-2-4:2010, Medical electrical equipment – Part 2-4: Particular requirements for the
299 basic safety and essential performance of cardiac defibrillators
300 IEC 60731:2011, Medical electrical equipment - Dosimeters with ionization chambers as used
301 in radiotherapy
302 IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
303 IEC 60976:2007, Medical electrical equipment – Medical electron accelerators – Functional
304 performance characteristics
305 IEC 61217:2011, Radiotherapy equipment – Coordinates, movements and scales
306 IEC 62083:2009, Medical electrical equipment – Requirements for the safety of radiotherapy
307 treatment planning systems
308 IEC 62366-1:2015/AMD1:2020, Medical devices – Application of usability engineering to
309 medical devices
IEC CDV 60601-2-92 © IEC 2026
310 201.3 Terms and definitions
311 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
312 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-3:2008,
313 IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021, IEC TR 60788:2004,
314 IEC 60601-2-33:2022 and the following apply.
315 NOTE The location of defined terms is listed in the Index of defined terms.
316 ISO and IEC maintain terminological databases for use in standardization at the following
317 addresses:
318 • IEC Electropedia: available at http://www.electropedia.org/
319 • ISO Online browsing platform: available at http://www.iso.org/obp
320 Addition:
321 201.3.201
322 ADAPTIVE RADIOTHERAPY
323 RADIOTHERAPY that monitors PATIENT anatomy or physiology and, based upon the monitored
324 information, allows changes to TREATMENT PARAMETERS throughout the course of TREATMENT
325 NOTE IMAGE GUIDED RADIATION THERAPY (IGRT) is one form of ADAPTIVE RADIOTHERAPY
326 [SOURCE: IEC 60601-2-1:2021, 3.201]
327 201.3.202
328 EQUIPMENT REFERENCE POINT
329 ERP
330 point in space used for referencing dimensions and positions of equipment and performing dosimetry
331 measurements
332 NOTE  Typically the EQUIPMENT REFERENCE POINT is coincident with the ISOCENTRE. If the beam delivery equipment is not
333 ISOCENTRIC, then the centre of the PATIENT alignment system may be used.
334 [SOURCE: IEC 60601-2-1:2021, 3.218]
335 201.3.203
336 EXTERNAL BEAM EQUIPMENT
337 EBE
338 external RADIATION EQUIPMENT utilizing ELECTRON ACCELERATORS, LIGHT ION BEAM MEDICAL
339 ELECTRICAL EQUIPMENT or RADIONUCLIDE BEAM THERAPY EQUIPMENT
340 [SOURCE: IEC 60601-2-68:2025, 3.208]
341 201.3.204
342 GUIDED RADIOTHERAPY
343 GRT
344 radiotherapy process by which the location of a radiotherapy beams relative to the intended
345 target region within a patient's anatomy is determined to enable any necessary corrections to
346 minimise the difference between the intended radiotherapy beams and intended target region
347 NOTE 1: this can involve both image-based and non-image-based guidance methods.
348 NOTE 2: Image-Guided Radiotherapy (IGRT) is a subset of Guided Radiotherapy (GRT)
IEC CDV 60601-2-92 © IEC 2026
349 201.3.205
350 IMAGE GUIDED RADIOTHERAPY
351 IGRT
352 radiotherapy process by which the location of a radiotherapy beam relative to the intended
353 TARGET VOLUME within a patient’s anatomy is determined by imaging of the TARGET VOLUME and
354 surrounding anatomical structures at the time of treatment, so as to enable any necessary
355 positional corrections to the intended relative location of beam to TARGET VOLUME
356 NOTE  The time period of "at the time of TREATMENT" is specified in the definitions of REAL-TIME IGRT, ONLINE IGRT and
357 OFFLINE IGRT.
358 [SOURCE: IEC 60601-2-1:2025, 3.211]
359 201.3.206
360 IMAGE RECONSTRUCTION
361 method to process acquired data into an image data set that can be used for analysis
362 NOTE The analysis of the reconstructed image data set can be for the purpose of IMAGE REGISTRATION against
363 reference data.
364 [SOURCE: IEC 60601-2-68:2025, 3.213]
365 201.3.207
366 IMAGE REGISTRATION
367 method for mapping or registering corresponding points from one image data set to another
368 NOTE  IMAGE REGISTRATION can be rigid or deformable.
369 [SOURCE: IEC 60601-2-68:2025, 3.214]
370 201.3.208
371 IMAGING SESSION
372 the length of continuous time that images are taken of the PATIENT while the PATIENT remains
373 on the PATIENT positioning device
374 NOTE  If the PATIENT is removed from the PATIENT positioning device, the imaging session is ended.
375 [SOURCE: IEC 60601-2-68:2025, 3.215]
376 201.3.209
377 LATENCY
378 time interval between occurrence or initiation of an event and its detection or effect
379 [SOURCE: IEC 60601-2-1:2021, 3.229]
380 201.3.210
381 MAGNETIC RESONANCE GUIDED RADIOTHERAPY
382 MRGRT
383 radiotherapy process by which the location of a radiotherapy beams relative the intended target
384 region within a patient's anatomy is determined through magnetic resonance scans, to enable
385 any necessary corrections to minimise the difference between the intended radiotherapy beams
386 and intended target region
387 Note 1: The magnetic resonance scans can be magnetic resonance imaging, localised spectroscopy, spectroscopic imaging,
388 synthetic or other methods based on the principle of nuclear magnetic resonance regardless of imaging or otherwise, which
389 utilize alternative techniques to accurately determine position of regions of interest.
IEC CDV 60601-2-92 © IEC 2026
390 201.3.211
391 MAGNETIC RESONANCE ISOCENTRE
392 MR ISOCENTRE
393 null point of the spatially encoding gradients
394 NOTE 1 Typically this also corresponds to the region of highest magnet homogeneity
395 NOTE 2 Typically this corresponds with the position in the system targeted for imaging.
396 [SOURCE: IEC 60601-2-33:2024, 3.228]
397 201.3.212
398 MRGRT SYSTEM
399 a system comprising of MRGRT EQUIPMENT and EXTERNAL BEAM EQUIPMENT
400 201.3.211
401 MRGRT EQUIPMENT
402 ME EQUIPMENT that provides MAGNETIC RESONANCE GUIDED RADIOTHERAPY functionality.
403 NOTE Guidance can be image based, or non-image based.
404 201.3.213
405 NORMAL USE
406 operation, including routine inspection and adjustments by any OPERATOR, and STAND-BY,
407 according to the INSTRUCTIONS FOR USE
408 NOTE  NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as intended
409 by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the
410 medical purpose, but maintenance, service, transport, etc. as well.
411 [SOURCE: IEC 60601-1: 2006+A13:2024, 3.71]
412 201.3.214
413 OFFLINE GRT
414 GRT for the purpose of PATIENT setup or TREATMENT PLAN adjustment to be applied in subsequent
415 TREATMENT delivery
416 201.3.215
417 ONLINE GRT
418 GRT for the purpose of PATIENT setup or TREATMENT position adjustment immediately prior to or
419 during the therapeutic IRRADIATION session requiring operator initiated adjustments.
420 NOTE The PATIENT stays on the PATIENT POSITIONER and is immobile during and in-between scanning and
421 TREATMENT.
422 201.3.216
423 REAL-TIME GRT
424 GRT that images or scans throughout therapeutic IRRADIATION and based upon that information,
425 allows automatic adjustments of TREATMENT position throughout the therapeutic IRRADIATION
426 without OPERATOR intervention
427 201.3.217
428 REFERENCE IMAGE
429 an image related to the TREATMENT PLAN to which subsequent images will be compared to align
430 the PATIENT or adjust the TREATMENT PLAN
IEC CDV 60601-2-92 © IEC 2026
431 NOTE 1 REFERENCE IMAGES could be acquired during the first treatment fraction from an ELECTRONIC PORTAL
432 IMAGING DEVICE
433 NOTE 2 There may be more than one REFERENCE IMAGE
434 NOTE 3 Examples of REFERENCE IMAGES can be digital reconstructed radiographs generated by the planning system
435 for comparison to 2D images taken at time of treatment or treatment planning CT images used for CBCT registration.
436 [SOURCE: IEC 60601-68:2025, 3.227]
437 201.3.218
438 SPECIFIC ABSORPTION
439 SA
440 radio-frequency energy absorbed per unit of mass, calculated from whole body sar.
441 NOTE 1 sa is also known as sed (specific energy dose) or sae (specific absorbed energy). Transition to the
442 exclusive use of sa is recommended.
443 NOTE 2 Use of sa associated with other sar types as used in Table 201.104 is not recommended.
444 NOTE 3 The use of the units [W·min/kg] and [kJ/kg] is acceptable. Providing the conversion factor and/or the
445 quantities in both units can be appropriate.
446 [SOURCE: IEC 60601-2-33:2024, 3.244]
447 201.3.219
448 SPECIFIC ABSORPTION RATE
449 SAR
450 radio-frequency power absorbed per unit of mass
451 [SOURCE: IEC 60601-2-33:2024, 3.245]
452 201.3.220
453 TREATMENT PARAMETER
454 factor that describes one aspect of the irradiation of a patient during radiotherapy, such as
455 radiation energy, source strength, treatment time
456 [SOURCE: IEC 60601-1:2012, 3.136]
457 201.3.221
458 USABILITY
459 characteristic that establishes effectiveness, efficiency and OPERATOR learnability and
460 satisfaction
461 [SOURCE: IEC 60601-1:2012, 3.136]
462 201.4 General requirements
463 Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
464 IEC 60601-1:2005/AMD2:2020 applies.
465 201.5 General requirements for testing ME EQUIPMENT
466 Clause 5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
467 IEC 60601-1:2005/AMD2:2020 applies, except as follows:
468 201.5.1 TYPE TESTS
IEC CDV 60601-2-92 © IEC 2026
469 201.5.1.101 Test grades
470 Three grades of TYPE TEST and two of SITE TEST procedures are SPECIFIED in this particular
471 standard. Their requirements are as follows:
472 – TYPE TEST grade A: An analysis of ME EQUIPMENT design, as related to the SPECIFIED
473 RADIATION safety provisions, which shall result in a statement included in the technical
474 description, regarding the working principles or constructional means by which the
475 requirement is fulfilled.
476 – TYPE TEST /SITE TEST grade B: Visual inspection or functional test or measurement of the ME
477 EQUIPMENT. The test shall be in accordance with the procedure SPECIFIED In this particular
478 standard and shall be based on operating states, including fault condition states, which are
479 achievable only without interference with the circuitry or construction of the ME EQUIPMENT.
480 – TYPE TEST/SITE TEST grade C: Functional test or measurement of the ME EQUIPMENT. The test
481 shall be in accordance with the principle specified in this particular standard. The SITE TEST
482 procedure shall be included in the technical description. When the procedure involves
483 operating states that require interference with circuitry or the construction of the ME
484 EQUIPMENT, the test should be performed by, or under the direct supervision of, the
485 MANUFACTURER or their agent.
486 201.5.4 Other conditions
487 Replacement:
488 The MANUFACTURER shall state in the ACCOMPANYING INFORMATION any additional requirements
489 for testing.
490 201.5.7 Humidity preconditioning treatment
491 Replacement of the first paragraph:
492 MRGRT EQUIPMENT for that the MANUFACTURER does not specify environmental control conditions
493 shall be subjected to a humidity preconditioning treatment prior to the tests of 8.7.4 and 8.8.3 of
494 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
495 201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
496 201.5.9.2.1 Test finger
497 Addition:
498 Where the nature of the installation renders parts inaccessible per the test with the standard
499 test finger and they can only be made accessible by use of a TOOL, those parts shall not be
500 considered ACCESSIBLE PARTS. The ACCOMPANYING INFORMATION shall describe such situations.
501 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
502 Clause 6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
503 IEC 60601-1:2005/AMD2:2020 applies.
504 201.7 ME EQUIPMENT identification, marking and documents
505 Clause 7 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
506 IEC 60601-1:2005/AMD2:2020 applies, except as follows:
507 201.7.1.1 USABILITY of the identification, marking and documents
IEC CDV 60601-2-92 © IEC 2026
508 Addition:
509 All sub-assemblies and components of MRGRT EQUIPMENT that can be removed in NORMAL USE,
510 and are relevant to compliance with this standard, shall be marked to ensure
511 – that they can be identified readily and correlated with their ACCOMPANYING INFORMATION
512 – that interchangeable devices are individually distinguishable to the OPERATOR both in
513 NORMAL USE and for the purpose of obtaining replacements.
514 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
515 Addition
516 Sub-clause 201.7.2 of IEC 60601-2-33:2022 applies.
517 ACCESSORIES provided by the MANUFACTURER of MRGRT EQUIPMENT for use inside the MR
518 ENVIRONMENT shall be marked in accordance with IEC 62570, except for those ACCESSORIES
519 designed with an exclusive mating connection to the MRGRT EQUIPMENT.
520 Note 3 An exclusive mating connection is generally used for immobilisation devises
521 201.7.3 Marking of controls and instruments
522 Replacement:
523 Sub-clause 201.7.4.3 of IEC 60601-2-33:2022 applies.
524 Additional subclause:
525 201.7.4.101 Provision of scales and indications for moving parts of an MRGRT EQUIPMENT
526 a) where a mechanical scale, numerical read out or a status indicator aligns with an IEC 61217
527 axis, then the IEC 61217 axis shall be used for each available IEC 61217 movement;
528 NOTE: This does not apply to a value for a movement that is not defined by IEC 61217
529 b) all mechanical scales, numerical read outs or status indicators, that the MANUFACTURER’S
530 HAZARD ANALYSIS indicates shall be available to the OPERATOR, shall be presented to the
531 OPERATOR.
532 The designation, direction of increasing value and zero position of all movements shall either
533 comply with IEC 61217 or if the equipment used is not IEC 61217 compliant, the ACCOMPANYING
534 INFORMATION shall state the coordinate transformation to IEC 61217 coordinates.
535 For OPERATOR set values, the values of the MRGRT EQUIPMENT shall be capable of being provided
536 to the OPERATOR in the same units and coordinate system as the device the values are applied
537 to.
538 Compliance is checked by inspection of ACCOMPANYING INFORMATION.
539 201.7.8 Indicator lights and controls
540 201.7.8.1 Colours of indicator lights
541 Addition:
IEC CDV 60601-2-92 © IEC 2026
542 The colour red shall be used for REAL-TIME MRGRT when the MRGRT SYSTEM cannot
543 automatically correct for misalignment, as this represents an urgent action required by the
544 OPERATOR
545 Compliance is checked by inspection.
546 201.7.9 ACCOMPANYING DOCUMENTATION
547 Addition:
548 Data required in the technical description to support SITE TEST compliance in Clauses 201.9,
549 201.10, 201.11, 201.14, 201.101, 201.102 and 201.103 is given in Table 201.101.
550 Table 201.101 – Data required in the technical description
Compliance Statement Details of, and Details of, and SPECIFIC SPECIFIC
subclause regarding data results from, results from, procedures and procedures and
from TYPE TESTS TYPE TESTS TYPE TESTS test conditions test conditions
grade A grade B grade C for SITE TESTS grade for SITE TESTS
B grade C
201.7.4.101 †
201.7.9.2.5 †
201.7.9.2.5.101  †
201.7.9.2 †
201.7.9.5 † †
201.7.9.6 †
201.9.6.2.1.102 †
201.9.8.101 a) b) c)
201.16.2.101 †  †
201.101.1 †
201.101.2  †
201.101.3  †
201.101.4  †
201.101.5 †  †
201.101.6 †  †
201.101.7 d) a)  b) c)
201.101.8 a) b)  b)
201.101.9.1 †  †
201.101.9.2 †  †
201.101.9.3 †
201.102.1.1  †
201.102.1.2  †
201.102.2  †
201.102.3 †  †
201.102.4 †
201.102.5 †
201.103.1 a) b) c)
201.103.2 a) b) c)
201.103.3.1 † †
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