oSIST prEN IEC 60601-2-18:2026

SLOVENSKI STANDARD
01-julij-2026
Medicinska električna oprema - 2-18. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti endoskopske opreme
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and
essential performance of endoscopic equipment
Medizinische elektrische Geräte - Teil 2-18: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von endoskopischen Geräten
Appareils électromédicaux - Partie 2-18: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'endoscopie
Ta slovenski standard je istoveten z: prEN IEC 60601-2-18:2026
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62D/2302/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-18 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2026-06-05 2026-08-28
SUPERSEDES DOCUMENTS:
62D/2193/RR
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):

ASPECTS CONCERNED:
Safety
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
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This document is still under study and subject to change. It should not be used for reference purposes.
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clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment

PROPOSED STABILITY DATE: 2030
NOTE FROM TC/SC OFFICERS:
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IEC CDV 60601-2-18 © IEC 2026
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 6
5 201.1 Scope, object and related standards . 7
6 201.2 Normative references . 8
7 201.3 Terminology and definitions . 9
8 201.4 General requirements . 11
9 201.5 General requirements for testing of ME EQUIPMENT . 12
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
11 201.7 ME EQUIPMENT identification, marking and documents . 13
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 17
15 201.11 Protection against excessive temperatures and other HAZARDS . 17
16 201.12 Accuracy of controls and instruments and protection against hazardous
17 outputs . 20
18 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 21
19 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
20 201.15 Construction of ME EQUIPMENT . 21
21 201.16 ME SYSTEMS . 22
22 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 22
23 202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 22
24 206 General requirements for basic safety and essential performance - Collateral
25 standard: USABILITY . 22
26 212 Requirements for medical electrical equipment and medical electrical systems
27 intended for use in the emergency medical services environment . 22
28 Annexes . 23
29 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
30 and ME SYSTEMS . 23
31 Annex D (informative) Symbols on marking . 25
32 Annex J (informative) Survey of insulation paths . 27
33 Annex AA (informative) Particular guidance and rationale . 32
34 AA.1 General guidance . 32
35 AA.2 Rationale for particular clauses and subclauses . 32
36 Annex BB (informative) Clauses of this standard addressing essential principles of
37 safety and performance of medical devices (GHTF/SG1/N41R9:2005) . 43
38 Bibliography . 45
40 Figure 201.101 – Identification of LIGHT EMISSION PART . 11
41 Figure 201.102 – Measurement of CAPACITIVELY-COUPLED HF LEAKAGE CURRENT from
42 conductive parts of an ENDOSCOPE . 21
43 Figure 201.J.101 – Insulation example 101 . 28
44 Figure 201.J.102 – Insulation example 102 . 29
45 Figure 201.J.103 – Insulation example 103 . 30
IEC CDV 60601-2-18 © IEC 2026
46 Figure 201.J.104 – Insulation example 104 . 31
47 Figure 201.J.105 – Insulation example 105 . 32
48 Figure 201.J.106 – Insulation example 106 . 32
49 Figure AA.101 – Illustration of typical CONFIGURATION FOR ENDOSCOPIC APPLICATION . 34
50 Figure AA.102 – Decision tree of the application of the INTERCONNECTION CONDITIONS . 36
51 Figure AA.103 – Identification of insertion portion and portion remaining outside the
52 PATIENT . 40
53 Table 201.101 – List of requirements for ESSENTIAL PERFORMANCE assessment . 13
54 Table 201.C.101 – Marking on the outside of ENDOSCOPIC EQUIPMENT or its parts . 24
55 Table 201.C.102 – Marking on the inside of ENDOSCOPIC EQUIPMENT or its parts . 24
56 Table 201.C.104 – ACCOMPANYING DOCUMENTS, general . 24
57 Table 201.C.105 – ACCOMPANYING DOCUMENTS, instructions for use . 25
58 Table 201.D.101 – Symbols for marking ENDOSCOPIC EQUIPMENT or its parts . 26
59 Table BB.1 – Correspondence between this standard and GHTF/SG1/N41R9:2005 . 44
IEC CDV 60601-2-18 © IEC 2026
63 INTERNATIONAL ELECTROTECHNICAL COMMISSION
64 ____________
67 MEDICAL ELECTRICAL EQUIPMENT –
69 Part 2-18: Particular requirements for the basic safety
70 and essential performance of endoscopic equipment
73 FOREWORD
74 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
75 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
76 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
77 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
78 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
79 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
80 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
81 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
82 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
83 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
84 consensus of opinion on the relevant subjects since each technical committee has representation from all
85 interested IEC National Committees.
86 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
87 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
88 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
89 misinterpretation by any end user.
90 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
91 transparently to the maximum extent possible in their national and regional publications. Any divergence between
92 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
93 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment
94 declared to be in conformity with an IEC Publication.
95 6) All users should ensure that they have the latest edition of this publication.
96 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
97 members of its technical committees and IEC National Committees for any personal injury, property damage or
98 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
99 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
100 Publications.
101 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
102 indispensable for the correct application of this publication.
103 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
104 rights. IEC shall not be held responsible for identifying any or all such patent rights.
105 International standard IEC 60601-2-18 has been prepared by IEC subcommittee 62D: Particular
106 medical equipment, software, and systems, of IEC technical committee 62, Medical equipment,
107 software, and systems.
108 This Amendment to the third edition cancels and replaces the third edition, published in 2009.
109 This edition constitutes a technical revision and has been aligned or harmonized with
110 IEC 60601-1:2020.
111 The main changes with respect to the previous edition include:
112 a) alignment of requirements with IEC 60601-1:2020;
113 b) New addition of essential performance definition;
114 C) New definition of the term: LIGHT EMISSION PART
115 d) Reference to ISO 80369-7, Small-bore connectors for liquids and gases in healthcare
116 applications — Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic
117 applications
IEC CDV 60601-2-18 © IEC 2026
118 e) reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy
119 devices, rather than defining different tests.
121 The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62D/XX/XX
62D/XX/XX
123 Full information on the voting for the approval of this particular standard can be found in the
124 report on voting indicated in the above table.
125 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
126 In this standard, the following print types are used:
127 – Requirements and definitions: roman type.
128 – Test specifications: italic type.
129 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
130 Normative text of tables is also in a smaller type.
131 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
132 NOTED: SMALL CAPITALS.
133 In referring to the structure of this standard, the term
134 – “clause” means one of the seventeen numbered divisions within the table of contents,
135 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
136 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
137 subclauses of Clause 7).
138 References to clauses within this standard are preceded by the term “Clause” followed by the
139 clause number. References to subclauses within this collateral standard are by number only.
140 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
141 combination of the conditions is true.
142 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
143 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
144 “shall” means that compliance with a requirement or a test is mandatory for compliance with
145 this standard;
146 “should” means that compliance with a requirement or a test is recommended but is not
147 mandatory for compliance with this standard;
148 “may” is used to describe a permissible way to achieve compliance with a requirement or test.
149 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
150 indicates that there is guidance or rationale related to that item in Annex AA.
151 A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
152 equipment, can be found on the IEC website.
IEC CDV 60601-2-18 © IEC 2026
154 The committee has decided that the contents of this publication will remain unchanged until the
155 maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data
156 related to the specific publication. At this date, the publication will be
157 • reconfirmed,
158 • withdrawn,
159 • replaced by a revised edition, or
160 • 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 publication using a colour printer.
IEC CDV 60601-2-18 © IEC 2026
165 INTRODUCTION
166 The minimum safety requirements specified in this particular standard are considered to provide
167 for a practical degree of safety in the operation of endoscopic equipment.
168 This particular standard amends and supplements IEC 60601-1:2005 and Amendment 1:2012
169 and Amendment 2:2020: Medical electrical equipment – Part 1: General requirements for basic
170 safety and essential performance, hereinafter referred to as ‘the general standard’.
171 The requirements are followed by specifications for the relevant tests.
IEC CDV 60601-2-18 © IEC 2026
173 MEDICAL ELECTRICAL EQUIPMENT –
175 Part 2-18: Particular requirements for the basic safety
176 and essential performance of endoscopic equipment
180 201.1 Scope, object and related standards
1)
181 Clause 1 of the general standard applies, except as follows:
182 201.1.1 * Scope
183 Replacement:
184 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
185 ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE
186 CONDITIONS.
187 201.1.2 Object
188 Replacement:
189 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
190 PERFORMANCE requirements for ENDOSCOPIC EQUIPMENT as defined in 201.3.204.
191 NOTE  This object includes endoscopic intense light source equipment which is part of the ENDOSCOPIC EQUIPMENT
192 including its SUPPLY UNIT, therefore IEC 60601-2-57, the reference [1] in the bibliography, does not apply.
193 201.1.3 Collateral standards
194 Addition:
195 This particular standard refers to those applicable collateral standards that are listed in Clause
196 2 of the general standard and Clause 201.2 of this particular standard.
197 IEC 60601-1-2:2017 and its Amendment 1:2023, IEC 60601-1-6:2010 and its Amendment
198 1:2013 and Amendment 2:2020, and IEC 60601-1-12:2014 and its Amendment 1:2020 apply as
199 modified in Clause 202, 206, 212. IEC 60601-1-3 and IEC 60601-1-11 do not apply.
200 201.1.4 Particular standards
201 Replacement:
202 In the IEC 60601 series, particular standards may modify, replace or delete requirements
203 contained in the general standard and collateral standards as appropriate for the particular
204 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
205 PERFORMANCE requirements.
206 A requirement of a particular standard takes priority over the general standard.
207 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
208 Collateral standards are referred to by their document number.
209 The numbering of clauses and subclauses of this particular standard corresponds to that of the
210 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of
211 Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where
212 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
213 standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in
214 this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral

1)
The general standard is IEC 60601-1:2005, 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 60601-2-18 © IEC 2026
215 standard, etc.). The changes to the text of the general standard are specified by the use of the
216 following words:
217 "Replacement" means that the clause or subclause of the general standard or applicable
218 collateral standard is replaced completely by the text of this particular standard.
219 "Addition" means that the text of this particular standard is additional to the requirements of the
220 general standard or applicable collateral standard.
221 "Amendment" means that the clause or subclause of the general standard or applicable
222 collateral standard is amended as indicated by the text of this particular standard.
223 Subclauses, figures or tables which are additional to those of the general standard are
224 numbered starting from 201.101. However due to the fact that definitions in the general standard
225 are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning
226 from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
227 Subclauses, figures or tables which are additional to those of a collateral standard are
228 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
229 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
230 The term "this standard" is used to make reference to the general standard, any applicable
231 collateral standards and this particular standard taken together.
232 Where there is no corresponding clause or subclause in this particular standard, the clause or
233 subclause of the general standard or applicable collateral standard, although possibly not
234 relevant, applies without modification; where it is intended that any part of the general standard
235 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
236 to that effect is given in this particular standard.
237 201.2 Normative references
238 Clause 2 of the general standard applies, except as follows:
239 Replacement:
240 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
241 safety and essential performance – Collateral standard: Usability
242 Amendment 1:2013
243 Amendment 2:2020
244 Addition:
245 IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic
246 safety and essential performance – Collateral Standard: Requirements for medical electrical
247 equipment and medical electrical systems intended for use in the emergency medical services
248 environment
249 Amendment 1:2020
250 IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
251 basic safety and essential performance of high frequency surgical equipment and high
252 frequency surgical accessories
253 Amendment 1:2023
254 IEC 60601-2-37:2024, Medical electrical equipment – Part 2-37: Particular requirements for the
255 basic safety and essential performance of ultrasonic medical diagnostic and monitoring
256 equipment
257 ISO 8600-1:2015, Endoscopes – Medical endoscopes and endotherapy devices – Part 1:
258 General requirements
IEC CDV 60601-2-18 © IEC 2026
259 201.3 Terminology and definitions
260 For the purposes of this document, the terms and definitions given in IEC 60601-1 apply, except
261 as follows:
262 NOTE  An index of defined terms is found beginning on page 47.
263 Addition:
264 201.3.201
265 * CAPACITIVELY COUPLED HF LEAKAGE CURRENT
266 unavoidable HF LEAKAGE CURRENT flowing due to capacitive coupling from an ENERGIZED
267 ENDOTHERAPY DEVICE that is the APPLIED PART of HF SURGICAL EQUIPMENT to the ENDOSCOPE
268 201.3.202
269 * CONFIGURATION FOR ENDOSCOPIC APPLICATION
270 combination of ENDOSCOPIC EQUIPMENT by means of INTERFACE CONDITIONS and/or
271 INTERCONNECTION CONDITIONS with one or more of the following:
272 – ENERGIZED ENDOTHERAPY DEVICE(S)
273 – MEDICAL ELECTRICAL EQUIPMENT
274 – non-MEDICAL ELECTRICAL EQUIPMENT
275 – MEDICAL ELECTRICAL SYSTEM
276 Note to entry:  Not all of the items in the CONFIGURATION FOR ENDOSCOPIC APPLICATION are included in the scope of
277 this particular standard. See Figure AA.101 in Annex AA for a diagrammatic explanation.
278 201.3.203
279 ENDOSCOPE
280 medical instrument having viewing means, with or without optics, introduced into a body cavity
281 through a natural or surgically created body opening for examination, diagnosis or therapy
282 [SOURCE: ISO 8600-1:2015, definition 3.1]
283 Note 1 to entry: ENDOSCOPES may be of rigid, flexible or capsule type, each of which may have different image pick -
284 up systems (e.g. via lenses or electronic/ultrasonic sensors) and different image transmission systems (e.g. optical
285 (via lenses or fiber bundles), or electrical/electronic).
286 Note 2 to entry: Note 1 to entry of definition 3.1 in ISO 8600-1 extended by 'or capsule type'.
287 201.3.204
288 ENDOSCOPIC EQUIPMENT
289 an ENERGIZED ENDOSCOPE together with its SUPPLY UNIT(s), as required for its INTENDED USE
290 201.3.205
291 ENDOTHERAPY DEVICE
292 medical device intended to be inserted into a natural or surgically created body opening during
293 endoscopic procedures, whether through the same or a different orifice from the ENDOSCOPE,
294 for examination, diagnosis or therapy
295 Note to entry: ENDOTHERAPY DEVICES include the instrument through which an ENDOSCOPE or ENDOTHERAPY DEVICE is
296 inserted, such as a guide tube, trocar tube or sliding tube, etc. ENDOTHERAPY DEVICES include the devices to be
297 inserted through openings other than the opening for an ENDOSCOPE, to ensure the safety of the devices for the
298 INTENDED USE under the endoscopic view.
299 [SOURCE: ISO 8600-1:2015, definition 3.2]
300 201.3.206
301 * ENERGIZED ENDOSCOPE
302 an ENDOSCOPE that is an APPLIED PART of ME EQUIPMENT using energy for producing the internal
303 view or image.
304 EXAMPLE  energy for illumination and/or signal processing.
305 201.3.207
306 * ENERGIZED ENDOTHERAPY DEVICE
307 an ENDOTHERAPY DEVICE that is an APPLIED PART of ME EQUIPMENT, which may or may not be
308 ENDOSCOPIC EQUIPMENT using energy for providing its INTENDED USE
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309 EXAMPLE  energy in form of HF current, ultrasound and/or laser
310 201.3.208
311 HIGH FREQUENCY
312 HF
313 frequencies less than 5 MHz and frequencies generally greater than 200 kHz
314 [SOURCE: IEC 60601-2-2:2017, definition 201.3.220]
315 201.3.209
316 HF SURGICAL EQUIPMENT
317 MEDICAL ELECTRICAL EQUIPMENT, which generates HIGH FREQUENCY currents intended for the
318 performance of surgical tasks, such as the CUTTING or COAGULATION of biological tissue by
319 means of these HIGH FREQUENCY currents
320 [SOURCE: IEC 60601-2-2:2017, definition 201.3.224]
321 201.3.210
322 * INTERCONNECTION CONDITIONS
323 conditions that shall be fulfilled to achieve BASIC SAFETY when one or more ENERGIZED
324 ENDOSCOPES are used simultaneously with one or more ENERGIZED ENDOTHERAPY DEVICES
325 201.3.211
326 INTERFACE CONDITIONS
327 conditions that shall be fulfilled to achieve BASIC SAFETY for any FUNCTIONAL CONNECTION
328 between ENDOSCOPIC EQUIPMENT and other ME EQUIPMENT or non-ME EQUIPMENT in the
329 CONFIGURATION FOR ENDOSCOPIC EQUIPMENT
330 201.3.212
331 LIGHT EMISSION PART
332 that part of the insertion portion of an ENERGIZED ENDOSCOPE surrounding the light emission
333 window
334 Note 1 to entry: For forward viewing ENERGIZED ENDOSCOPES, the LIGHT EMISSION PART is the area within three times
335 the maximum diameter of the insertion portion, measured at the tip, but with a minimum of 10 mm and a maximum
336 of 25 mm, with no removable attachment such as a distal cover. See also Figure 201.101.
337 Note 2 to entry: For side viewing ENERGIZED ENDOSCOPES, the LIGHT EMISSION PART is the area within three times the
338 maximum diameter of the insertion portion, measured from the centre of the light emission window in both longitudinal
339 directions, but with a minimum of 10 mm and a maximum of 25 mm for each direction. See also Figure 201.101.
341 Figure 201.101 – Identification of LIGHT EMISSION PART
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342 201.3.213
343 NEUTRAL ELECTRODE
344 NE
345 electrode intended to provide an electrical return path for the MONOPOLAR application of HIGH
346 FREQUENCY current with such a low current density in the PATIENT’S tissue that effects such as
347 excessive rise in temperature or unwanted burns are avoided
348 Note to entry: The NEUTRAL ELECTRODE is also known as plate, plate electrode, passive, return or dispersive electrode.
349 [SOURCE: IEC 60601-2-2:2017, definition 201.3.230]
350 201.3.214
351 RATED ACCESSORY VOLTAGE
352 maximum peak HF output voltage which may be applied to a MONOPOLAR HF SURGICAL
353 ACCESSORY with respect to an NE connected to the PATIENT. For a BIPOLAR HF SURGICAL
354 ACCESSORY, the maximum peak HF output voltage which may be applied to pairs of opposite
355 polarity
356 [SOURCE: IEC 60601-2-2:2017, definition 201.3.231
357 201.3.215
358 * SUPPLY UNIT
359 that part of ME EQUIPMENT, directly connected to an ENDOSCOPE, supplying necessary functions
360 forming the ENERGIZED ENDOSCOPE
361 201.3.216
362 ULTRASONIC DIAGNOSTIC EQUIPMENT
363 MEDICAL ELECTRICAL EQUIPMENT that is intended for ultrasonic medical examination
364 [SOURCE: IEC 60601-2-37:2024, definition 201.3.217]
365 201.4 General requirements
366 Clause 4 of the general standard applies, except as follows:
367 201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
368 Addition:
369 201.4.1.101 * ENERGIZED ENDOTHERAPY DEVICES
370 Where requirements for ENDOTHERAPY DEVICES given in other applicable particular standards
371 conflict with the requirements for INTERCONNECTION CONDITIONS of this particular standard, the
372 requirements of this particular standard shall take precedence.
373 201.4.1.102 ULTRASONIC DIAGNOSTIC EQUIPMENT
374 For the ultrasonic safety aspects of ENDOSCOPIC EQUIPMENT which is also ULTRASONIC
375 DIAGNOSTIC EQUIPMENT, that part which is intended for ultrasonic diagnosis shall comply with the
376 requirements of IEC 60601-2-37 and the other parts shall comply with the requirements of this
377 particular standard.
378 201.4.1.103 * SUPPLY UNITS
379 For SUPPLY UNITS providing a plurality of functions where different particular standards apply,
380 the appropriate parts of these shall comply with the requirements of the relevant particular
381 standards.
382 201.4.3 ESSENTIAL PERFORMANCE
383 Addition:
384 Subclause 201.13.1.101 and 201.12.4.4 of this particular standard requires to ensure that there
385 is no unacceptable RISK in the specific conditions listed in Table 201.101. The MANUFACTURER
386 shall take into account these conditions during the identification PROCESS of ESSENTIAL
387 PERFORMANCE in subclause 4.3 of the general standard.
388 NOTE  Other ESSENTIAL PERFORMANCE requirements can be added by application of RISK MANAGEMENT.
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389 Table 201.101 – List of requirements for ESSENTIAL PERFORMANCE assessment
Requirement Subclause
To ensure that there is no unacceptable RISK, if the view observed by the 201.13.1.101
OPERATOR has an unexpected image orientation.
To ensure that there is no unacceptable RISK, if there is a lack of, or 201.12.4.4
significant error in, provision of a particular color spectral output necessary
to provide accurate diagnosis or therapy, which is not identifiable by a
trained OPERATOR.
To ensure that there is no unacceptable RISK that the OPERATOR is viewing 201.13.1.101
the live image during an endoscopic procedure, rather than a recorded
image.
391 201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
392 Addition:
393 Light guide cables shall be treated as parts that can come in contact with the PATIENT for the
394 purposes of this particular standard unless the RISK MANAGEMENT FILE indicates otherwise for
395 specific configurations.
396 201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
397 Addition:
398 To be SINGLE FAULT SAFE, the INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS as
399 defined by the MANUFACTURER shall be taken into account as part of the RISK MANAGEMENT
400 PROCESS.
401 Compliance is checked by inspection of the RISK MANAGEMENT FILE.
402 201.5 General requirements for testing of ME EQUIPMENT
403 Clause 5 of the general standard applies, except as follows:
404 201.5.1 TYPE TESTS
405 Addition:
406 NOTE  The definition of ENERGIZED ENDOSCOPE necessarily includes ENDOSCOPES that are energized only by light
407 energy and for which the required F-TYPE APPLIED PART isolation is provided in the SUPPLY UNIT or the light guide
408 cable. See subclause 201.5.1 in Annex AA.
409 201.5.7 * Humidity preconditioning treatment
410 Addition:
411 ACCESS COVERS of ENDOSCOPIC EQUIPMENT which can be opened without the use of a TOOL, but
412 which inactivate the EQUIPMENT (e.g. by an interlock) once opened, may remain closed and/or
413 attached during humidity preconditioning unless the RISK MANAGEMENT PROCESS suggests that
414 the ENDOSCOPIC EQUIPMENT can be exposed to high humidity during the periods when ACCESS
415 COVERS are opened.
416 ENERGIZED ENDOSCOPES and ENERGIZED ENDOTHERAPY DEVICES which according to their
417 INTENDED USE or instructions for use are subject to disinfection and/or sterilization processes
418 prior to use are excluded from humidity preconditioning treatment according to this subclause,
419 but shall instead be subjected to subclauses 11.6.6 and/or 11.6.7 of the general standard, as
420 appropriate, prior to any relevant tests.
421 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
422 Clause 6 of the general standard applies, except as follows:
423 201.6.2 Protection against electric shock
424 Replacement of final paragraph:
IEC CDV 60601-2-18 © IEC 2026
425 APPLIED PARTS of ENDOSCOPIC EQUIPMENT shall be classified as TYPE BF APPLIED PARTS or TYPE
426 CF APPLIED PARTS (see 8.3). These APPLIED PARTS may be classified as DEFIBRILLATION-PROOF
427 APPLIED PARTS.
428 201.7 ME EQUIPMENT identification, marking and documents
429 Clause 7 of the general standard applies, except as follows:
430 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
431 201.7.2.9 * IP classification
432 Addition:
433 ENERGIZED ENDOSCOPES and ENERGIZED ENDOTHERAPY DEVICES supplied with specific
434 instructions detailing allowable reprocessing methods and parameters are excluded from this
435 requirement of the general standard. No symbol is required to identify the reprocessing
436 procedure by this particular standard. See also subclause 7.9.2.12 of the general standard.
437 201.7.2.10 APPLIED PARTS
438 Addition to the exception in the fourth paragraph:
439 Where no marking of an APPLIED PART is practicable, the required marking may be affixed to the
440 individual packaging.
441 Compliance is checked by inspection.
442 Additional subclauses:
443 201.7.2.101 Alternative marking
444 Information, which is accessible by the user on an output device (e.g. display) of ENDOSCOPIC
445 EQUIPMENT is considered equivalent to marking on the EQUIPMENT for requirements 7.2.3, 7.2.5,
446 7.2.11 and 7.2.13 of the general standard, as long as the marking is visible at the time the
447 information is required.
448 Compliance is checked by inspection of the results of the USABILITY ENGINEERING PROCESS or by
449 inspection of the ACCOMPANYING DOCUMENTS.
450 201.7.2.102 * Illumination lamps
451 SUPPLY UNITS having replaceable illumination lamps accessible without the use of a TOOL shall
452 be provided with permanently affixed and clearly legible markings near the lamps, either inside
453 or outside the SUPPLY UNIT, giving the MODEL OR TYPE REFERENCE (preferably by use of the
454 symbol 111 of Table 201.D.101).
455 For replaceable illumination lamps built into the distal end of ENDOSCOPES, the MODEL OR TYPE
456 REFERENCE shall be stated in the ACCOMPANYING DOCUMENTS as a minimum.
457 For replaceable illumination lamps accessible only by SERVICE PERSONNEL with the use of a
458 TOOL, the MODEL OR TYPE REFERENCE shall be stated in the ACCOMPANYING DOCUMENTS as a
459 minimum.
460 201.7.4 Marking of controls and instruments
461 201.7.4.3 Units of measure
462 Addition:
463 For ENDOSCOPES and ENDOTHERAPY DEVICES, the measure 'French' or 'Charrière', symbol F ,
r
464 may be used to indicate the size of certain circular or non-circular cross-sections, defined as:
465 F = 3u/
r
466 where u is the perimeter of the cross-section, expressed in mm.
467 NOTE  Taken from ISO 8600-1.
IEC CDV 60601-2-18 © IEC 2026
468 201.7.6 Symbols
469 201.7.6.2 Symbols from Annex D
470 Addition:
471 At the option of the MANUFACTURER, symbols to denote certain functions of ENDOSCOPIC
472 EQUIPMENT may be used, but if used shall be explained in the instructions for use. If symbols
473 are used, 201.D.101 lists those symbols, which may be used to denote the functions described.
474 201.7.9 ACCOMPANYING DOCUMENTS
475 201.7.9.2 Instructions for use
476 201.7.9.2.2 * Warning and safety notices
477 Addition:
478 The instructions for use of ENDOSCOPIC EQUIPMENT shall include the following warning and safety
479 notices where appropriate:
480 Warning and safety notices regarding ENDOSCOPIC EQUIPMENT:
481 a) Warnings if surface temperatures on an APPLIED PART are likely to exceed the limits
482 determined by Table 23 or Tabel 24 of the general standards (see also 201.11.1.1).
483 b) Warnings that high energy radiated light may be transmitted from the light emission window
484 of the ENDOSCOPE, giving rise to high temperatures in front of the light emission window,
485 and advice on how to minimize associated RISKS.
486 c) Advice on prevention of unacceptable RISKS if ENDOSCOPIC EQUIPMENT loses functions.
487 d) Advice on prevention of HAZARDOUS SITUATIONS, which may cause HARM, such as, burns and
488 eye damage, by the replacement of the illumination lamp.
489 e) Warning that the TYPE F APPLIED PART status of ENERGIZED ENDOSCOPES intended for use with
490 a multiplicity of SUPPLY UNITS and/or light guide cables is ensured by, for instance, using
491 only SUPPLY UNITS having isolated light guide output sockets.
492 f) Warning that before each use, the outer surface of the portions of ENERGIZED ENDOSCOPES
493 which are intended to be inserted into a PATIENT should be checked to ensure there are no
494 unintended rough surfaces, sharp edges or protrusions which may cause HARM.
495 g) Warning that before each use or after a change of viewing modes / settings, the OPERATOR
496 should check to ensure the view observed through the ENDOSCOPE provides a live image
497 (rather than a stored one) with intended color rendering (by viewing of objects with known
498 color) and has the correct image orientation.
499 Warning and safety notices regarding INTERCONNECTION CONDITIONS:
500 h) Warning that INTERCONNECTION CONDITIONS require the APPLIED PARTS of other ME EQUIPMENT
501 used within the CONFIGURATION FOR ENDOSCOPIC APPLICATION to be TYPE BF APPLIED PARTS or
502 TYPE CF APPLIED PARTS.
503 i) Warning regarding RISKS resulting from gas embolism caused by, for example, over-
504 insufflation of air, inert gas prior to HIGH FREQUENCY surgery, or laser assist gas.
505 j) Warning that when ENERGIZED ENDOSCOPES are used with ENERGIZED ENDOTHERAPY DEVICES,
506 PATIENT LEAKAGE CURRENTS may be additive.
507 NOTE  This is particularly important if a TYPE CF applied part endoscope is used, in which case a TYPE CF applied
508 part energized endotherapy device should be used in order to minimize total patient leakage current.
509 k) Advice on avoidance of risks in the event of explosive gas concentrations being present in
510 the area of use of HF ENERGIZED ENDOTHERAPY DEVICES.
511 l) Advice concerning the safe use of ENERGIZED ENDOSCOPES and/or ENERGIZED ENDOTHERAPY
512 DEVICES with laser equipment, including avoidance of potential eye damage to the OPERATOR
513 by, for example, wearing suitable protective filtering spectacles, or by inserting a suitable
514 filter in the eyepiece of the ENERGIZED ENDOSCOPE.
IEC CDV 60601-2-18 © IEC 2026
515 m) Advice to check the compatibility of the ENDOSCOPIC EQUIPMENT with any ACCESSORIES or
516 ENERGIZED ENDOTHERAPY DEVICES before each use according to any criteria for safe use as
517 defined in the instructions for use.
518 n) Advice to check the outer surface of the portions of any ENERGIZED ENDOTHERAPY DEVICES
519 which are intended to be inserted into a PATIENT before each use to ensure there are no
520 unintended rough surfaces, sharp edges or protrusions which may cause HARM.
521 Warning and safety notices regarding INTERFACE CONDITIONS:
522 o) Advice when ENDOSCOPIC EQUIPMENT is used with ACCESSORIES, other ME EQUIPMENT or non-
523 ME EQUIPMENT within a CONFIGURATION FOR ENDOSCOPIC APPLICATION, on the avoidance of
524 RISKS caused by their use together (see also 16.2 of the general standard and 201.15.4.1
525 of this particular standard).
526 Compliance is checked by inspection of the instructions for use.
527 201.7.9.2.12 Cleaning, disinfection and sterilization
528 Addition:
529 If the ACCOMPANYING DOCUMENTS provide instructions for visual or other inspection by the
530 OPERATOR or the RESPONSIBLE ORGANIZATION to enable checking the suitability for reuse prior to
531 each use, then the number of cycles the ENDOSCOPIC EQUIPMENT parts or ACCESSORIES can
532 tolerate need not be given.
533 201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
534 Addition:
535 When ENERGIZED ENDOTHERAPY DEVICES are used with HF SURGICAL EQUIPMENT, advice
536 concerning their safe use shall be given in the instructions for use in accordance with the
537 relevant requirements of IEC 60601-2-2.
538 201.8 Protection against electrical HAZARDS from ME EQUIPMENT
539 Clause 8 of the general standard applies, except as follows:
540 201.8.3 Classification of APPLIED PARTS
541 Replacement of requirement c):
542 c) An APPLIED PART of ENDOSCOPIC EQUIPMENT shall be a TYPE BF APPLIED PART or TYPE CF
543 APPLIED PART. INTERCONNECTION CONDITIONS require the ENERGIZED ENDOTHERAPY DEVICE
544 used within the CONFIGURATION FOR ENDOSCOPIC APPLICATION also to be TYPE BF APPLIED
545 PARTS or TYPE CF APPLIED PARTS.
546 201.8.5 Separation of parts
547 201.8.5.2 Separation of PATIENT CONNECTIONS
548 201.8.5.2.1 F-TYPE APPLIED PARTS
549 Addition:
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