oSIST prEN IEC 60601-2-44:2026
(Main)Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie
Medicinska električna oprema - 2-44. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za računalniško tomografijo
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2026
Medicinska električna oprema - 2-44. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za računalniško tomografijo
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and
essential performance of X-ray equipment for computed tomography
Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements à rayonnement X de
tomodensitométrie
Ta slovenski standard je istoveten z: prEN IEC 60601-2-44:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62B/1400/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-44 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-11-21 2026-02-13
SUPERSEDES DOCUMENTS:
62B/1376/CD, 62B/1384A/CC
IEC SC 62B : MEDICAL IMAGING EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):
SC 62A,SC 62C
ASPECTS CONCERNED:
Electromagnetic Compatibility,Safety
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TITLE:
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and
essential performance of X-ray equipment for computed tomography
PROPOSED STABILITY DATE: 2029
NOTE FROM TC/SC OFFICERS:
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
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IEC CDV 60601-2-44 © IEC 2025
1 CONTENTS
3 201.1 Scope, object and related standards . 9
4 201.1.1 Scope . 9
5 201.1.2 Object. 9
6 201.1.3 Collateral standards . 10
7 201.1.4 Particular standards . 11
8 201.2 Normative references . 11
9 201.3 Terms and definitions . 12
10 201.4 General requirements . 22
11 201.4.3 ESSENTIAL PERFORMANCE . 22
12 201.4.5 Alternative RISK CONTROL measures or test methods for ME
13 EQUIPMENT or ME SYSTEMS . 23
14 201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 23
15 201.5 General requirements for testing of ME EQUIPMENT . 23
16 201.5.7 Humidity preconditioning treatment . 23
17 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 24
18 201.6.2 Protection against electric shock . 24
19 201.6.6 MODE OF OPERATION . 24
20 201.7 ME EQUIPMENT identification, marking and documents . 24
21 201.7.2.15 Cooling conditions. 24
22 201.7.8.1 Colours of indicator lights . 24
23 201.7.9 ACCOMPANYING DOCUMENTS . 24
24 201.7.9.3 Technical description . 25
25 201.7.9.101 Reference to ACCOMPANYING DOCUMENTS . 25
26 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 26
27 201.8.4 Limitation of voltage, current or energy . 27
28 201.8.4.101 Limitation of high voltage to the NOMINAL X-RAY TUBE
29 VOLTAGE 27
30 201.8.4.102 Detachable high-voltage cable connections . 27
31 201.8.4.103 Unacceptably high voltage in the MAINS PART . 27
32 201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 27
33 201.8.7.3 Allowable values . 27
34 201.8.8 Insulation . 28
35 201.8.8.3 Dielectric strength . 28
36 201.8.9 CREEPAGE DISTANCES and AIR CLEARANCES . 29
37 201.8.9.1Values . 29
38 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 29
39 201.9.2.4 Emergency stopping devices . 32
40 201.9.2.5 Release of PATIENT . 32
41 201.9.8.2 TENSILE SAFETY FACTOR . 33
42 201.9.8.3.3 Dynamic forces due to LOADING from persons . 33
43 201.10 Protection against unwanted and excessive RADIATION HAZARDS . 33
44 201.11 Protection against excessive temperatures and other HAZARDS . 33
45 201.11.1 Excessive temperatures in ME EQUIPMENT . 33
46 201.11.1.1 Maximum temperature during NORMAL USE . 33
IEC CDV 60601-2-44 © IEC 2025
47 201.12 Accuracy of controls and instruments and protection against hazardous
48 outputs . 34
49 201.12.1 Accuracy of controls and instruments . 34
50 201.12.1.101 Accuracy of RADIATION output . 34
51 201.12.1.102 Accuracy of recorded CT EXAMINATION data . 34
52 201.13 Hazardous situations and fault conditions . 34
53 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 34
54 201.15 Construction of ME EQUIPMENT . 34
55 201.16 ME SYSTEMS . 34
56 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 35
57 201.101 Requirements for CT SCANNERS providing images for RADIOTHERAPY
58 TREATMENT PLANNING (RTP) . 35
59 202Electromagnetic compatibility – Requirements and tests . 39
60 203 General requirements for RADIATION protection in diagnostic X-ray equipment . 40
61 203.4 General requirements . 40
62 203.4.1 Statement of compliance . 40
63 203.5 ME EQUIPMENT identification, marking and documents . 40
64 203.5.2 ACCOMPANYING DOCUMENTS . 40
65 203.5.2.2 Dosimetric calibration . 40
66 203.5.2.3 General requirements for the reference of subassemblies
67 and ACCESSORIES . 40
68 203.5.2.4 INSTRUCTIONS FOR USE . 40
69 203.6 RADIATION management . 42
70 203.6.2 Initiation and termination of the IRRADIATION . 42
71 203.6.2.1 Normal initiation and termination of the IRRADIATION . 42
72 203.6.2.2 Safety measures against failure of normal termination of the
73 IRRADIATION . 42
74 203.6.3 RADIATION dose and RADIATION QUALITY . 42
75 203.6.3.1 Adjustment OF RADIATION dose and RADIATION QUALITY . 42
76 203.6.3.2 Reproducibility of the RADIATION output . 42
77 203.6.4 Indication of operational states . 42
78 203.6.4.1 Indication of the X-RAY SOURCE ASSEMBLY selected . 42
79 203.6.4.2 Indication of LOADING STATE . 42
80 203.6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION . 43
81 203.6.5 AUTOMATIC CONTROL SYSTEM . 43
82 203.6.6 Scattered RADIATION reduction. 43
83 203.6.7 Imaging performance . 43
84 203.6.7.2 System performance . 43
85 203.6.7.2.1 Quality Assurance . 43
86 203.6.7.2.2 Performance information . 44
87 203.6.7.3 NOMINAL FOCAL SPOT value . 44
88 203.6.7.4 RADIATION DETECTOR or X-RAY IMAGE RECEPTOR. 44
89 203.6.7.101 Metal Artifact Reduction . 44
90 203.7 RADIATION QUALITY . 45
91 203.7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT . 45
92 203.7.2 Waveform of the X-RAY TUBE VOLTAGE . 45
93 203.7.3 Indication of FILTER properties . 45
94 203.7.4 Test for FILTRATION by irremovable materials . 46
95 203.7.5 Test for ADDED FILTERS and materials . 46
IEC CDV 60601-2-44 © IEC 2025
96 203.7.6 Test for HALF-VALUE LAYER . 46
97 203.8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY
98 FIELD and IMAGE RECEPTION AREA. 46
99 203.8.1 General . 46
100 203.8.4 Confinement of extra-focal RADIATION . 46
101 203.8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA . 47
102 203.9 FOCAL SPOT TO SKIN DISTANCE . 47
103 203.10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY
104 IMAGE RECEPTOR . 48
105 203.11 Protection against RESIDUAL RADIATION . 48
106 203.12 Protection against LEAKAGE RADIATION . 48
107 203.12.1 General . 48
108 203.12.3 Statement of reference LOADING conditions . 48
109 203.13 Protection against STRAY RADIATION . 48
110 203.13.1General . 48
111 203.13.101 Statements in the ACCOMPANYING DOCUMENTS . 49
112 203.101 Emergency TERMINATION of X-RADIATION . 49
113 203.102 Visual indication . 50
114 203.103 Indication of operational READY STATE . 50
115 203.104 Connection of external INTERLOCKS . 50
116 203.105 Charging mode INTERLOCK . 51
117 203.106 Control of RADIATION output . 51
118 203.106.1 General control functions . 51
119 203.106.2 REFERENCE CLINICAL PROTOCOLS . 51
120 203.106.3 AUTOMATIC EXPOSURE CONTROL (AEC) . 52
121 203.106.3.1 General . 52
122 203.106.3.3 Information to be provided . 52
123 203.107 Safety measures against excessive X-RADIATION. 53
124 203.108 Dose Checks (DOSE NOTIFICATION, DOSE ALERT) . 54
125 203.108.1 DOSE NOTIFICATION . 54
126 203.108.2 DOSE ALERT . 55
127 203.108.2.1 General . 55
128 203.108.2.2 DOSE ALERT for CT GUIDED INTERVENTIONAL PROCEDURES . 56
129 203.108.3 Checking Prior to Saving Protocols and Audit Capability . 57
130 203.109 Information regarding perfusion scanning . 57
131 203.110 Dose statements . 57
132 203.110.1 CTDI . 57
133 203.110.2 CTDI . 59
free air
134 203.111 DOSE PROFILE statement . 60
135 203.112 Display and recording of CTDI and DLP . 60
vol
136 203.115 GEOMETRIC EFFICIENCY IN THE Z DIRECTION . 62
137 203.116 Indication and position of the TOMOGRAPHIC PLANE AND TOMOGRAPHIC
138 SECTION(S) . 62
139 203.117 Indication and position of the reconstructed section(s) . 63
140 203.119 Indication and position of the PATIENT SUPPORT . 63
141 Annex AA (informative) Choosing LOADING FACTORS for tests . 64
142 Annex BB (informative) . 64
IEC CDV 60601-2-44 © IEC 2025
143 Annex CC (informative) The CTDI concept in IEC 60601-2-44: Relationship
144 between CTDI and CTDI . 65
100 ∞
145 CC.1 Evolution of CTDI in editions of IEC 60601-2-44 . 66
146 CC.2 Introduction and justification of a new definition for CTDI . 67
147 CC.3 Underestimations of CTDI . 68
∞
148 CC.4 Use of CTDI to estimate dose for object sizes other than those of the
vol
149 CTDI phantoms . 69
150 Annex DD (informative) Measuring CTDI . 69
free air
151 ANNEX EE (informative) Reference Template for the Content for Listing of REFERENCE
152 CLINICAL PROTOCOLS . 72
154 Figure 201.101 – Coordinate system . 16
155 Figure 201.102 – Illustration of {N T}, R and {N T} + R . 18
156 Figure 201.101.2.1 – Vertical alignment of TOMOGRAPHIC PLANE . 36
157 Figure 201.101.2.2 – Alignment of the PATIENT SUPPORT and its movement direction . 37
158 Figure 201.101.2.3 – Rotational alignment of the reconstructed CT images . 38
159 Figure 203.8.4.1 – Zone of extra-focal RADIATION . 47
160 Figure 203.102 – Minimum dimensions for STRAY RADIATION measurement . 49
161 Figure CC.1 – CTDI versus beam width along z . 67
w
163 Table 203.101 − Test pattern for CTDI . 60
free air
164 Table CC.1 – Ratios of CTDI by phantom length . 69
IEC CDV 60601-2-44 © IEC 2025
167 INTERNATIONAL ELECTROTECHNICAL COMMISSION
168 ____________
170 MEDICAL ELECTRICAL EQUIPMENT –
172 Part 2-44: Particular requirements for the basic safety and essential
173 performance of X-ray equipment for computed tomography
176 FOREWORD
177 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
178 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
179 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
180 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
181 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
182 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
183 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
184 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
185 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
186 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
187 consensus of opinion on the relevant subjects since each technical committee has representation from all
188 interested IEC National Committees.
189 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
190 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
191 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
192 misinterpretation by any end user.
193 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
194 transparently to the maximum extent possible in their national and regional publications. Any divergence between
195 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
196 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
197 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
198 services carried out by independent certification bodies.
199 6) All users should ensure that they have the latest edition of this publication.
200 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
201 members of its technical committees and IEC National Committees for any personal injury, property damage or
202 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
203 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
204 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
205 indispensable for the correct application of this publication.
206 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
207 rights. IEC shall not be held responsible for identifying any or all such patent rights.
208 IEC 60601-2-44 has been prepared by subcommittee 62B: Medical imaging equipment,
209 software, and systems, of IEC technical committee 62: Medical equipment, software, and
210 systems.
211 This fourth edition cancels and replaces the third edition published in 2009, Amendment 1:2012
212 and Amendment 2:2016. This edition constitutes a technical revision.
213 This particular standard has been prepared to provide, based on IEC 60601-
214 1:2005+A1:2012+A2:2020 (3.2 edition) and its collaterals, a complete set of safety
215 requirements for ME EQUIPMENT for computed tomography.
216 This edition 4 of IEC 60601-2-44 includes several changes to account for the evolved technical
217 state-of-the-art of ct-scanner and to harmonize this standard with other international and
218 national standards and regulations. The main changes are:
219 − a new requirements for calculation, display and recording of SSDE (according to IEC
220 62985), and of CTDIvol for scan projection radiogram (SPR)
221 − a revision of the requirements for ct scanner used for radiotherapy planning,
IEC CDV 60601-2-44 © IEC 2025
222 − a revision of requirements for dose checks (dose notification, dose alert), in particular
223 for interventional procedures
224 − a revision of requirements for dose statements in the accompanying documents
225 − a new requirement for a DICOM image based dose survey
226 In addition, several other changes and new requirements have been included
227 In detail, this particular standard compared to the IEC 60601-2-44:2009+A1:2012+A2:2016 (3.2
228 edition) includes the following changes:
229 a) New definition of terms for
230 − RECONSTRUCTED SECTION THICKNESS,
231 − NOMINAL RECONSTRUCTED SECTION THICKNESS,
232 − NOMINAL TOTAL ACQUISITION BEAM WIDTH,
233 − READY STATE,
234 − INSTRUCTIONS FOR USE,
235 − REFERENCE CLINICAL PROTOCOL,
236 − CTDI DOSIMETRY PHANTOM,
237 − ALTERNATE DOSE ALERT BEHAVIOR,
238 − CT GUIDED INTERVENTIONAL PROCEDURE,
239 − CTDI (Z),
VOL
240 − SSDE(z),
241 − PATIENT SUPPORT
242 b) Terms revised for CTDI and DLP, new definitions for CTDI and DLP for scan mode
VOL VOL
243 (SPR)
244 c) New notes regarding ESSENTIAL PERFORMANCE
245 d) Requirements deleted for SENSITIVITY PROFILE STATEMENT
246 e) New requirements for
247 − specification in ACCOMPANYING DOCUMENTS
248 − Warning against unexpected movement of the PATIENT SUPPORT
249 − CTDIVOL and DLP for SPR
250 − Display/Recording of SSDE
251 − Dose Summary as DICOM image and DICOM Dose SR
252 − REFERENCE CLINICAL PROTOCOLS
253 − AEC with XYZ-modulation
254 − prevention of unlimited scanning
255 − Metal Artifact Reduction (MAR) in Imaging performance
256 f) Requirements revised for
257 − Linear movements of the PATIENT SUPPORT and gantry in Emergency
258 stopping devices
259 − Deterministic Effects
260 − Dose Checks
261 − System performance
262 − RTP (alignments, typ. modes, etc.)
263 − user information (CTDI100, etc.)
264 − Dose statements
265 − indicator lights
266 − Safety measures against excessive X-radiation
267 − Indication and position of the tomographic Plane and tomographic
268 section(s)
269 − Indication of loading state
270 − axial scan modes for CTDI measurements
271 − Lightmarker (203.117): Indication of an (offset) reference plane instead of
272 indication of the tomographic plane possible
273 g) Several changes to account for state-of-the-art and for clarification
274 h) Add informative Annex for Reference Template for the Content for Listing of
275 REFERENCE CLINICAL PROTOCOLS
276 The text of this International Standard is based on the following documents:
IEC CDV 60601-2-44 © IEC 2025
Draft Report on voting
62B/XXX/FDIS 62B/XXX/RVD
278 Full information on the voting for its approval can be found in the report on voting indicated in
279 the above table.
280 The language used for the development of this International Standard is English.
281 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
282 accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
283 at http://www.iec.ch/members_experts/refdocs. The main document types developed by IEC
284 are described in greater detail at www.iec.ch/standardsdev/publications.
285 In this document, the following print types are used:
286 • requirements and definitions: roman type;
287 • test specifications: italic type;
288 • informative material appearing outside of tables, such as notes, examples and references: in smaller type.
289 Normative text of tables is also in a smaller type;
290 • TERMS DEFINED IN CLAUSE 3 OF IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
291 IEC 60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
292 In referring to the structure of this document, the term
293 • "clause" means one of the eighteen numbered divisions within the table of contents,
294 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
295 • "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
296 subclauses of Clause 7).
297 References to clauses within this document are preceded by the term "Clause" followed by the
298 clause number. References to subclauses within this document are by number only.
299 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
300 combination of the conditions is true.
301 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
302 Directives, Part 2. For the purposes of this document, the auxiliary verb:
303 • "shall" means that compliance with a requirement or a test is mandatory for compliance with
304 this document;
305 • "should" means that compliance with a requirement or a test is recommended but is not
306 mandatory for compliance with this document;
307 • "may" is used to describe a permissible way to achieve compliance with a requirement or
308 test.
309 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
310 indicates that there is guidance or rationale related to that item in Annex AA.
311 A list of all parts of the IEC 60601 and IEC 80601 series, published under the general title:
312 Medical electrical equipment, can be found on the IEC website.
313 The committee has decided that the contents of this document will remain unchanged until the
314 stability date indicated on the IEC website under webstore.iec.ch/?ref=menu in the data related
315 to the specific document. At this date, the document will be
IEC CDV 60601-2-44 © IEC 2025
316 • reconfirmed,
317 • withdrawn,
318 • replaced by a revised edition, or
319 • 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.
IEC CDV 60601-2-44 © IEC 2025
323 MEDICAL ELECTRICAL EQUIPMENT –
325 Part 2-44: Particular requirements for the basic safety and essential
326 performance of X-ray equipment for computed tomography
330 201.1 Scope, object and related standards
1)
331 Clause 1 of the general standard applies, except as follows:
332 201.1.1 Scope
333 Replacement:
334 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT
335 SCANNERS, hereafter also referred to as ME EQUIPMENT.
336 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
337 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
338 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
339 NOTE 1 See also 4.2 of the general standard.
340 The scope of this document is limited to CT SCANNERS intended to be used for head and/or body
341 imaging characterised by an ENCLOSURE of the X-ray source(s) and imaging detector(s) in a
342 common protective cover in the shape of a toroid. It includes safety requirements for the X-RAY
343 GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are
344 integrated with an X-RAY TUBE ASSEMBLY.
345 NOTE 2 This standard does not intend to address interventional systems as described in IEC 60601-2-43 and cone-
346 beam CT scanners integrated into a radiotherapy systems as described in IEC 60601-2-68 and dental cone-beam
347 CT scanners as described in IEC 60601-2-63.
348 NOTE 3 The body includes cardiac, extremities, neck, etc.
349 The scope of this International Standard excludes RADIOTHERAPY SIMULATORS and systems
350 where the image is created by a source other than an X-RAY TUBE.
351 201.1.2 Object
352 Replacement:
353 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
354 PERFORMANCE requirements for CT SCANNERS as defined in 201.3.201, to ensure safety, and to
355 specify methods for demonstrating compliance with those requirements, for CT SCANNERS.
356 NOTE 1 Requirements for reproducibility, linearity, constancy and accuracy are given because of their relationship
357 to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered necessary for
358 safety.
359 NOTE 2 Both the levels for compliance and the tests prescribed to determine compliance reflect the fact that the
360 safety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance. The combinations
361 of LOADING FACTORS specified for the tests are therefore limited in number but chosen from experience as being
—————————
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
IEC CDV 60601-2-44 © IEC 2025
362 appropriate in most cases. It is considered important to standardize the choice of combinations of LOADING FACTORS
363 so that comparison can be made between tests performed in different places on different occasions. However,
364 combinations other than those specified could be of equal technical validity.
365 NOTE 3 The safety philosophy on which this standard is based is described in the introduction to the general
366 standard and in IEC TR 60513.
367 NOTE 4 Concerning RADIOLOGICAL PROTECTION, it is assumed that MANUFACTURERS and RESPONSIBLE
368 ORGANIZATIONS accept the general principles of justification, optimisation, and application of dose limits of the
2)
369 International Commission on Radiological Protection as stated in ICRP 103, 2007, paragraph 203, [12] namely:
370 (a) “The principle of justification: Any decision that alters the RADIATION exposure situation should do more good than
371 harm.”
372 (b) “The principle of optimisation of protection: The likelihood of incurring exposures, the number of people exposed,
373 and the magnitude of their individual doses should all be kept as low as reasonably achievable, taking into account
374 economic and societal factors.”
375 (c) “The principle of application of dose limits: The total dose to any individual from regulated sources in planned
376 exposure situations other than medical exposure of PATIENTS should not exceed the appropriate limits recommended
377 by the Commission.”
378 (d) "Application of dose limits for the PATIENT dose might be to the PATIENT’S detriment. Therefore, dose limits should
379 not be applied to medical exposures. However, considerations should be given to the use of dose constraints or
380 investigation levels for some common diagnostic procedures. This concept, now renamed as diagnostic reference
381 levels, has been introduced in a large number of countries."
382 NOTE 5 It is recognized that many of the judgements necessary to follow the ICRP general principles have to be
383 made by the RESPONSIBLE ORGANIZATIONS and not by the MANUFACTURER of the ME EQUIPMENT.
384 201.1.3 Collateral standards
385 Addition:
386 This particular standard refers to those applicable collateral standards that are listed in
387 Clause 2 of the general standard and Clause 201.2 of this particular standard.
388 A requirement of a particular standard takes priority over applicable collateral standards.
389 IEC 60601-1-2:2014+AMD1:2020 and IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 apply as
3 )
390 modified in Clauses 202 and 203. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 ,
4) 5)
391 IEC 60601-1-11 and IEC 60601-1-12 do not apply.
392 All other published collateral standards in the IEC 60601-1 series apply as published.
393 If a CT-SCANNER is intended for use in EMERGENCY MEDICAL SERVICES ENVIRONMENT, this situation
394 shall be taken into account in the RISK MANAGEMENT FILE.
395 If an ECG monitor is integrated into the CT SYSTEM for the sole purposes of providing triggers
396 for cardiac and vascular examinations and other examinations affected by cardiac motion, the
397 ECG monitor does not need to conform to IEC 60601-2-25 or IEC 60601-2-27.
398 For collateral standards published after this particular standard, MANUFACTURERS need to
399 determine the applicability in accordance with the RISK MANAGEMENT PROCESS.
—————————
2)
Figures in square brackets refer to the Bibliography.
3)
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
4)
IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment
5)
IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems
intended to be used in the emergency medical services environment
IEC CDV 60601-2-44 © IEC 2025
401 201.1.4 Particular standards
402 Replacement:
403 In the IEC 60601 series, particular standards may modify, replace or delete requirements
404 contained in the general standard and collateral standards as appropriate for the particular
405 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
406 PERFORMANCE requirements.
407 A requirement of a particular standard takes priority over the general standard.
408 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
409 Collateral standards are referred to by their document numbers.
410 The numbering of clauses and subclauses of this particular standard corresponds to that of the
411 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of
412 Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where
413 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
414 standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this
415 particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.).
416 The changes to the text of the general standard are specified by the use of the following words:
417 "Replacement" means that the clause or subclause of the general standard or applicable
418 collateral standard is replaced completely by the text of this particular standard.
419 "Addition" means that the text of this particular standard is additional to the requirements of the
420 general standard or applicable collateral standard.
421 "Amendment" means that the clause or subclause of the general standard or applicable
422 collateral standard is amended as indicated by the text of this particular standard.
423 Subclauses, figures or tables which are additional to those of the general standard are
424 numbered starting from 201.101. However, due to the fact that definitions in the general
425 standard are numbered 3.1 through 3.154, additional definitions in this standard are numbered
426 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
427 aa), bb), etc.
428 Subclauses, figures or tables which are additional to those of a collateral standard are
429 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
430 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
431 The term "this standard" is used to make reference to the general standard, any applicable
432 collateral standards and this particular standard taken together.
433 Where there is no corresponding section, clause or subclause in this particular standard, the
434 section, clause or subclause of the general standard or applicable collateral standard, although
435 possibly not relevant, applies without modification; where it is intended that any parts of the
436 general standard or applicable collateral standard, although possibly relevant, is not to be
437 applied, a statement to that effect is given in this particular standard.
438 201.2 Normative references
439 NOTE Informative references are listed in the bibliography.
440 Addition:
IEC CDV 60601-2-44 © IEC 2025
441 The following referenced documents are indispensable for the application of this document. For dated
442 references, only the edition cited applies. For undated references, the latest edition of the referenced
443 document (including any amendments) applies.
444 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment – Part 1: General
445 requirements for basic safety and essential performance
446 IEC 61223-3-5:2019, Evaluation and routine testing in medical imaging departments – Part 3-
447 5: Acceptance tests – Imaging performance of computed tomography X-ray equipment
448 ISO 12052:2017, Health informatics – Digital imaging and communication in medicine (DICOM)
449 including workflow and data management
450 IEC 60336:2020, Medical electrical equipment - X-ray tube assemblies for medical diagnosis -
451 Focal spot dimensions and related characteristics
452 IEC 62985:2019, Methods for calculating size specific dose estimates (SSDE) for computed
453 tomography
454 IEC 61674: 2024, Medical electrical equipment – Dosimeters with ionization chambers and/or
455 semiconductor detectors as used in X-ray diagnostic imaging
457 201.3 Terms and definitions
458 For the purposes of this document, the terms and definitions given in IEC 60601-
459 1:2005,IEC 60601-1:2005+AMD1:2012 and IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC
460 60601-1-3:2008, IEC 60601-1-3:2008+AMD1:2013 and IEC 60601-1-
461 3:2008+AMD1:2013+AMD2:2021, and IEC 60788:2004 apply, except as follows:
462 NOTE 101 An index of defined terms is to be found at the end of this document.
463 NOTE 102 In accordance with the definitions in IEC 60601-1-3, in this standard unless otherwise indicated:
464 – values of X-RAY TUBE VOLTAGE refer to peak values, transients being disregarded;
465 – values of X-RAY TUBE CURRENT refer to mean values.
466 Addition:
467 201.3.201
468 CT SCANNER
469 X-RAY EQUIPMENT intended to generate cross-sectional images of the head and/or body by
470 computer reconstruction of X-ray tra
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