oSIST prEN IEC 60601-2-36:2026

SLOVENSKI STANDARD
01-september-2026
Medicinska električna oprema - 2-36. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za zunajtelesno litotripsijo
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and
essential performance of equipment for extracorporeally induced lithotripsy
Medizinische elektrische Geräte - Teil 2-36: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten zur extrakorporal
induzierten Lithotripsie
Appareils électromédicaux - Partie 2-36: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils pour lithotritie créée de façon
extracorporelle
Ta slovenski standard je istoveten z: prEN IEC 60601-2-36:2026
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62D/2311/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-36 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2026-07-10 2026-10-02
SUPERSEDES DOCUMENTS:
62D/2240/CD, 62D/2266A/CC
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):
TC 87
ASPECTS CONCERNED:
Electromagnetic Compatibility,Safety
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which t hey
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
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 2-36: Particular requirements for the basic safety and essential
performance of equipment for extracorporeally induced lithotripsy

PROPOSED STABILITY DATE: 2030
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

IEC CDV 60601-2-36 © IEC 2026
1 CONTENTS
2 CONTENTS . 1
3 FOREWORD . 2
4 INTRODUCTION . 5
5 201.1 Scope, object and related standards . 6
6 201.2 Normative references . 7
7 201.3 Terms and definitions . 8
8 201.4 General requirements . 9
9 201.5 General requirements for testing ME EQUIPMENT . 9
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
11 201.7 ME EQUIPMENT identification, marking and documents . 10
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 10
13 201.9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS . 11
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 11
15 201.11 Protection against excessive temperatures and other HAZARDS . 11
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 11
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 13
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 13
19 201.15 Construction of ME EQUIPMENT . 13
20 201.16 ME SYSTEMS . 13
21 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 13
22 202 * ELECTROMAGNETIC COMPATIBILITY – Requirements and tests . 13
23 Annexes . 13
24 Annex AA (informative) Particular guidance and rationale . 14
25 Annex BB (informative) Definition of coordinates, FOCUS and TARGET LOCATION . 15
26 Bibliography . 16
27 Index of defined terms used in this particular standard . 17
29 Figure BB.1 – Geometrical FOCUS distribution . 17
IEC CDV 60601-2-36 © IEC 2026
32 INTERNATIONAL ELECTROTECHNICAL COMMISSION
33 ____________
35 MEDICAL ELECTRICAL EQUIPMENT –
37 Part 2-36: Particular requirements for the basic safety and essential
38 performance of therapy equipment for extracorporeally induced focused
39 pressure pulses
41 FOREWORD
42 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
43 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
44 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
45 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
46 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
47 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
48 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
49 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
50 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
51 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
52 consensus of opinion on the relevant subjects since each technical committee has representation from all
53 interested IEC National Committees.
54 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
55 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
56 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
57 misinterpretation by any end user.
58 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
59 transparently to the maximum extent possible in their national and regional publications. Any divergence between
60 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
61 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
62 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
63 services carried out by independent certification bodies.
64 6) All users should ensure that they have the latest edition of this publication.
65 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
66 members of its technical committees and IEC National Committees for any personal injury, property damage or
67 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
68 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
69 Publications.
70 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
71 indispensable for the correct application of this publication.
72 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
73 rights. IEC shall not be held responsible for identifying any or all such patent rights.
74 International standard IEC 60601-2-36 has been prepared by IEC subcommittee 62D: Particular
75 medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
76 software, and systems.
77 This third edition cancels and replaces the second edition of IEC 60601-2-36 published in 2014.
78 This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its
79 Amendment 1:2012 and Amendment 2:2020.
IEC CDV 60601-2-36 © IEC 2026
81 The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/xxxx/FDIS 62D/xxxx/RVD
83 Full information on the voting for the approval of this particular standard can be found in the
84 report on voting indicated in the above table.
85 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
86 In this standard, the following print types are used:
87 – Requirements and definitions: roman type.
88 – Test specifications: italic type.
89 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
90 Normative text of tables is also in a smaller type.
91 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
92 NOTED: SMALL CAPITALS.
93 In referring to the structure of this standard, the term
94 – “clause” means one of the numbered divisions within the table of contents, inclusive of all
95 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
96 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
97 subclauses of Clause 7).
98 References to clauses within this standard are preceded by the term “Clause” followed by the
99 clause number. References to subclauses within this particular standard are by number only.
100 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
101 combination of the conditions is true.
102 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
103 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
104 – “shall” means that compliance with a requirement or a test is mandatory for compliance with
105 this standard;
106 – “should” means that compliance with a requirement or a test is recommended but is not
107 mandatory for compliance with this standard;
108 – “may” is used to describe a permissible way to achieve compliance with a requirement or
109 test.
110 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
111 indicates that there is guidance or rationale related to that item in Annex AA.
112 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
113 equipment, can be found on the IEC website.
IEC CDV 60601-2-36 © IEC 2026
115 The committee has decided that the contents of this publication will remain unchanged until the
116 stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to
117 the specific publication. At this date, the publication will be
118 • reconfirmed,
119 • withdrawn,
120 • replaced by a revised edition, or
121 • amended.
IEC CDV 60601-2-36 © IEC 2026
124 INTRODUCTION
125 This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of therapy
126 equipment for EXTRACORPOREALLY INDUCED FOCUSED PRESSURE PULSES. It amends and
127 supplements IEC 60601-1:2005, IEC 60601-1:2005/A1:2012 and IEC 60601-1:2005/A2:2020:
128 Medical electrical equipment – Part 1: General requirements for basic safety and essential
129 performance), hereinafter referred to as the general standard.
130 The aim of this third edition is to bring this particular standard up to date with reference to the
131 third edition of the general standard through reformatting and technical changes.
132 This particular standard applied to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for
133 EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other
134 medical applications of therapeutic EXTRACORPOREALLY INDUCED FOCUSED PRESSURE PULSES,
135 hereafter referred to as ME EQUIPMENT.
136 Only naming extracorporeal shock wave LITHOTRIPSY (ESWL) in the title was misleading
137 because that method does only describe the medical application for stone fragmentation
138 (LITHOTRIPSY) and does not cover other applications where for example tissue is stimulated by
139 extracorporeal shock wave therapy (ESWT).
140 In order to generalize the title and don´t restrict it to a medical application method the title
141 was changed as following.
142 “Particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of therapy
143 equipment for EXTRACORPOREALLY INDUCED FOCUSED PRESSURE PULSES”.
144 ESWL and ESWT are both representing therapies where EXTRACORPOREALLY INDUCED FOCUSED
145 PRESSURE PULSES are used. The title change reflects the change from a possibly restricted
146 description of the medical application method to the universal description of the physical mode
147 of action.
148 The requirements of this particular standard take priority over those of the general standard.
149 A “General guidance and rationale” for the more important requirements of this particular
150 standard is included in Annex AA. It is considered that knowledge of the reasons for these
151 requirements will not only facilitate the proper application of the standard but will, in due course,
152 expedite any revision necessitated by changes in clinical practice or as a result of developments
153 in technology. However, Annex AA does not form part of the requirements of this standard.
IEC CDV 60601-2-36 © IEC 2026
155 MEDICAL ELECTRICAL EQUIPMENT –
157 Part 2-36: Particular requirements for basic safety and essential
158 performance of therapy equipment for extracorporeally induced focused
159 pressure pulses
163 201.1 Scope, object and related standards
164 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
165 Clause 1, applies, except as follows:
166 201.1.1 Scope
167 Replacement:
168 This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of therapy
169 equipment for EXTRACORPOREALLY INDUCED FOCUSED PRESSURE PULSES as defined in 201.3.212,
170 hereafter referred to as ME EQUIPMENT. The applicability of this particular standard is limited to
171 components directly involved in the PRESSURE PULSE treatment, such as, but not limited to, the
172 generator of the PRESSURE PULSE, and their interactions with other devices, such as e.g. patient
173 support, imaging, monitoring or treatment planning devices. Such devices themselves are
174 excluded from this standard, because they are treated in other applicable IEC standards.
175 This particular standard does not apply to:
176 – ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy;
177 – ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND
178 (HITU) and other therapy equipment as described in Annex AA;
179 Note:
180 IEC 60601-2-5 is the particular standard for ULTRASOUND PHYSIOTHERAPY EQUIPMENT and
181 IEC 60601-2-62 is the particular standard for HITU equipment.
182 201.1.2 * Object
183 Replacement:
184 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
185 PERFORMANCE requirements of therapy equipment for EXTRACORPOREALLY INDUCED PRESSURE
186 PULSES as defined in 201.3.212.
187 201.1.3 Collateral standards
188 Addition:
189 This particular standard refers to those applicable collateral standards that are listed in Clause
190 2 of the general standard and Clause 201.2 of this particular standard.
191 IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-10, IEC 60601-
192 1-11 and IEC 60601-1-12 do not apply. All other published collateral standards in the
193 IEC 60601-1 series apply as published.
194 IEC 60601-1-8 is also not applicable because appropriate warning signals are sufficiently
195 specified in IEC 60601-1.
IEC CDV 60601-2-36 © IEC 2026
196 201.1.4 Particular standards
197 Replacement:
198 In the IEC 60601 series, particular standards may modify, replace or delete requirements
199 contained in the general standard and collateral standards as appropriate for the particular
200 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
201 PERFORMANCE requirements.
202 A requirement of a particular standard takes priority over the general standard.
203 For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
204 Collateral standards are referred to by their document number.
205 The numbering of clauses and subclauses of this particular standard corresponds to that of the
206 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of
207 Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where
208 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
209 standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in
210 this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral
211 standard, etc.). The changes to the text of the general standard are specified by the use of the
212 following words:
213 "Replacement" means that the clause or subclause of the general standard or applicable
214 collateral standard is replaced completely by the text of this particular standard.
215 "Addition" means that the text of this particular standard is additional to the requirements of the
216 general standard or applicable collateral standard.
217 "Amendment" means that the clause or subclause of the general standard or applicable
218 collateral standard is amended as indicated by the text of this particular standard.
219 Subclauses, figures or tables which are additional to those of the general standard are
220 numbered starting from 201.101. However, due to the fact that definitions in the general
221 standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered
222 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
223 aa), bb), etc.
224 Subclauses, figures or tables which are additional to those of a collateral standard are
225 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
226 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
227 The term "this standard" is used to make reference to the general standard, any applicable
228 collateral standards and this particular standard taken together.
229 Where there is no corresponding clause or subclause in this particular standard, the clause or
230 subclause of the general standard or applicable collateral standard, although possibly not
231 relevant, applies without modification; where it is intended that any part of the general standard
232 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
233 to that effect is given in this particular standard.
234 201.2 Normative references
235 Clause 2 of the general standard applies, except as follows:
236 Replacement:
IEC CDV 60601-2-36 © IEC 2026
237 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
238 safety and essential performance – Collateral standard: Electromagnetic compatibility –
239 Requirements and tests
240 IEC 60601-1-2:2014/AMD1:2020
241 Addition:
242 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
243 and essential performance
244 IEC 60601-1:2005/AMD1:2012
245 IEC 60601-1:2005/AMD2:2020
246 IEC 60601-2-5:202x, Medical electrical equipment – Part 2-5: Particular requirements for the
247 basic safety and essential performance of ultrasonic physiotherapy equipment
248 IEC 60601-2-62:2013, Particular requirements for the basic safety and essential performance
249 of high intensity therapeutic ultrasound (HITU) equipment
250 IEC 61846:2025, Ultrasonics–Therapeutic focused short pressure pulse sources:
251 Characterization of fields
252 201.3 Terms and definitions
253 NOTE An index of defined terms is found beginning on page 20.
254 For the purpose of this document, the terms and definitions given in IEC 60601-1:2005,
255 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 apply, except as follows:
256 Additional definitio
...