oSIST prEN IEC 80601-2-58:2022

SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-58:2022
01-november-2022
Medicinska električna oprema - 2-58. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti naprav za odstranjevanje leč in naprav za vitrektomijo pri očesni
kirurgiji
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and
essential performance of lens removal devices and vitrectomy devices for ophthalmic
surgery
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und
Geräte zur Glaskörperentfernung in der Augenchirurgie
Appareils électromédicaux - Partie 2-58: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de
vitrectomie pour la chirurgie ophtalmique
Ta slovenski standard je istoveten z: prEN IEC 80601-2-58:2022
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN IEC 80601-2-58:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 80601-2-58:2022
62D/1969/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-58 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-09-09 2022-12-02
SUPERSEDES DOCUMENTS:
62D/1914/CD, 62D/1936A/CC

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.

TITLE:
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential
performance of lens removal devices and vitrectomy devices for ophthalmic surgery

PROPOSED STABILITY DATE: 2028

NOTE FROM TC/SC OFFICERS:

Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
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.

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 © IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 6
5 201.1 Scope, object and related standards . 8
6 201.2 Normative references . 10
7 201.3 Terms and definitions . 11
8 201.4 General requirements . 13
9 201.5 General requirements for testing of ME EQUIPMENT . 13
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
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 . 15
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 15
15 201.11 Protection against excessive temperatures and other HAZARDS . 15
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 27
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
19 201.15 Construction of ME EQUIPMENT . 27
20 201.16 * ME SYSTEMS. 27
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
22 202 Electromagnetic disturbances – Requirements and tests . 28
23 202.5.2.2.2 * Requirements applicable to ME EQUIPMENT and ME SYSTEMS specified
24 for use only in a shielded location SPECIAL ENVIRONMENT . 28
25 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
26 and ME SYSTEMS . 30
27 201.C.5 ACCOMPANYING DOCUMENTS, instructions for use. 30
28 Annex D (informative) Symbols on marking (See Clause 7). 31
29 Annex AA (informative) Particular guidance and rationale . 32
30 A.A.1 General guidance. 32
31 A.A.2 Rationale for particular clauses and subclauses . 32
32 Annex BB (informative) Reference to the general safety and performance requirements . 39
33 Bibliography . 41
34 Index of defined terms . 42
35
36 Figure 201.101 – Test method for gravity fed IRRIGATION . 17
37 Figure 201.102 – Test method for pressurized IRRIGATION . 18
38 Figure 201.103 – Test method for ASPIRATION pressure measurement/display accuracy . 19
39 Figure 201.104 – Test method for ultrasonic velocity of tip accuracy . 23
40
41 Table 201.101 – Key of symbols for Figure 201.101 to Figure 201.103 . 19
42 Table 201.C.101 – ACCOMPANYING DOCUMENTS, instructions for use of LENS REMOVAL
43 DEVICES and VITRECTOMY DEVICES or their parts . 30

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44
45 INTERNATIONAL ELECTROTECHNICAL COMMISSION
46 ____________
47
48 MEDICAL ELECTRICAL EQUIPMENT –
49
50 Part 2-58: Particular requirements for the basic safety
51 and essential performance of lens removal devices
52 and vitrectomy devices for ophthalmic surgery
53
54 FOREWORD
55 1) The International Electrotechnical Commission (IEC) is a worldwide organization for stand ardization comprising
56 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
57 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
58 this end and in addition to other activities, IEC publishes International Standards, Technical Specifi cations,
59 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
60 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
61 in the subject dealt with may participate in this preparatory work. International, governmental and non-
62 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
63 with the International Organization for Standardization (ISO) in accordanc e with conditions determined by
64 agreement between the two organizations.
65 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
66 consensus of opinion on the relevant subjects since each technical committee has representation from all
67 interested IEC National Committees.
68 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
69 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
70 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
71 misinterpretation by any end user.
72 4) In order to promote international uniformity, IEC National Committees undertake t o apply IEC Publications
73 transparently to the maximum extent possible in their national and regional publications. Any divergence
74 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
75 the latter.
76 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
77 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
78 services carried out by independent certification bodies.
79 6) All users should ensure that they have the latest edition of this publication.
80 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
81 members of its technical committees and IEC National Committees for any personal injury, property damage or
82 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees ) and
83 expenses arising out of the publication, use of, or reliance upon, this IEC P ublication or any other IEC
84 Publications.
85 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
86 indispensable for the correct application of this publication.
87 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
88 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
89 This version of IEC 80601-2-58 bears the edition number 3.0. It consists of the third
90 edition (202X-XX) [documents 62D/XXXX/FDIS and 62D/XXXX/RVD].
91 International standard IEC 80601-2-58 has been prepared by subcommittee 62D:
92 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
93 practice, and subcommittee SC 7: Ophthalmic optics and instruments of ISO technical
94 committee 172: Optics and photonics.
95 It is published as a double logo standard.
96 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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97 In this standard, the following print types are used:
98 – Requirements and definitions: roman type.
99 – Test specifications: italic type.
100 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
101 Normative text of tables is also in a smaller type.
102 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
103 NOTED: SMALL CAPITALS.
104 In referring to the structure of this standard, the term
105 – “clause” means one of the seventeen numbered divisions within the table of contents,
106 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
107 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
108 subclauses of Clause 7).
109 References to clauses within this standard are preceded by the term “Clause” followed by the
110 clause number. References to subclauses within this particular standard are by number only.
111 In this standard, the conjunctive “or” is used as an “inclusive or” , so a statement is true if any
112 combination of the conditions is true.
113 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
114 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
115 – “shall” means that compliance with a requirement or a test is mandatory for compliance
116 with this standard;
117 – “should” means that compliance with a requirement or a test is recommended but is not
118 mandatory for compliance with this standard;
119 – “may” is used to describe a permissible way to achieve compliance with a requirement or
120 test.
121 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
122 indicates that there is guidance or rationale related to that item in Annex AA.
123 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
124 equipment, can be found on the IEC website.
125

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126 The committee has decided that the contents of the base publication and its amendment will
127 remain unchanged until the stability date indicated on the IEC web site under
128 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the
129 publication will be
130 • reconfirmed,
131 • withdrawn,
132 • replaced by a revised edition, or
133 • amended.
134
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.
135

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136 INTRODUCTION
137 LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used widely in ophthalmology to perform
138 anterior-segment and posterior-segment surgery on the human eye. Commercial use of these
139 MEDICAL ELECTRICAL EQUIPMENT devices began in the early 1970s. This International Standard
140 defines particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
141 REMOVAL DEVICES and VITRECTOMY DEVICES, comprising an equipment console, surgical
142 HANDPIECES and ACCESSORIES connected to this ME EQUIPMENT.
143 In many parts of the world LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used in
144 combination by ophthalmic surgeons to perform combined anterior-segment (lens removal)
145 and posterior-segment (vitreoretinal) surgical PROCEDURES to maximize surgical outcomes.
146 For this reason both LENS REMOVAL DEVICES and VITRECTOMY DEVICES are covered in this
147 International Standard.
148 As all particular standards in the IEC 60601-1 series are based on the general standard
149 IEC 60601-1, the user of this standard is reminded that RISK MANGEMENT plays an important
150 role in the use of this particular standard. Compliance with the requirement s of this particular
151 standard should be documented in the RISK MANAGEMENT FILE to ensure the HAZARDS
152 associated with the product have been considered fully.
153

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154
155 INTRODUCTION TO EDITION 3
156 This third edition modifies the content of the second edition including amendment 1 of IEC
157 80601-2-58 published in 2016. This third edition constitutes a technical revision.
158 This amendment includes the following significant technical changes with respect to the
159 second edition including amendment 1:
160 a) the alignment of this standard based on the amendment of IEC 60601-1:2005, IEC 60601-
161 1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
162 b) updating collateral, particular and general standard references to align with amendments
163 to the general standard and other collateral standards;
164 c) updated normative references;
165 d) Added new requirement for particulate matter from APPLIED PARTS in sub-clause 201.9.5.3;
166 e) Adding the shadow light method in sub-clause 201.12.1.101.7;
167 f) Clarify test conditions for EMC requirements in sub-clause 202.7.1.2;
168 g) Updated Table D.4 refences to include specific IEC references to the symbols and delete
169 Annex AA, clause 201.7.6.101;
170 h) Include a new annex to address the relevant general safety and performance requirements of
1
171 European regulation (EU) 2017/745 [1] (Annex BB).
172
173

1
Numbers in square brackets refer to the Bibliography.

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174 MEDICAL ELECTRICAL EQUIPMENT –
175
176 Part 2-58: Particular requirements for the basic safety
177 and essential performance of lens removal devices
178 and vitrectomy devices for ophthalmic surgery
179
180
181
182 201.1 Scope, object and related standards
2
183 Clause 1 of the general standard applies, except as follows:
184 201.1.1 * Scope
185 Replacement:
186 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
187 REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208
188 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL
189 ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.
190 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
191 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
192 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
193 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
194 within the scope of this standard are not covered by specific requirements in this standard
195 except in 7.2.13 and 8.4.1 of the general standard.
196 NOTE See also 4.2 of the general standard.
197 201.1.2 Object
198 Replacement:
199 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
200 PERFORMANCE requirements for LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic
201 surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be
202 connected to the ME EQUIPMENT and are to be tested together or individually.
203 NOTE 1 This document has been prepared to address the relevant general safety and performance
204 requirements of European regulation (EU) 2017/745 [1] as indicated in Annex BB.
205 201.1.3 * Collateral standards
206 Addition:
207 This particular standard refers to those applicable collateral standards that are listed in
208 Clause 2 of the general standard and Clause 201.2 of this particular standard.
209 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 applies as modified in Clause 202.
210 IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021,

2
The general standard is IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance

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211 IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and IEC 60601-1-9:2007/AMD2:2020,
212 IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-
213 10:2007/AMD2:2020, IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020, and
214 IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 do not apply.
215 IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020,
216 and IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-
217 8:2006/AMD2:2020 shall be assessed for applicability through the RISK MANAGEMENT process.
218 Compliance shall be determined and documented in the RISK MANAGEMENT FILE.
219 201.1.4 Particular standards
220 Replacement:
221 In the IEC 60601 series, particular standards specify BASIC SAFETY and ESSENTIAL
222 PERFORMANCE requirements for the particular ME EQUIPMENT and ME SYSTEMS. Particular
223 standards may modify, replace or delete requirements contained in the standard and
224 applicable collateral standards as appropriate for the particular ME EQUIPMENT and ME SYSTEMS
225 under consideration. A requirement of a particular standard takes priority over the general
226 standard and applicable collateral standards.
227 For brevity, IEC 60601-1 is referred to in this particular standard as the “general standard”.
228 Collateral standards are referred to by their document number.
229 The numbering of clauses and subclauses of this particular standard corresponds to that of
230 the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
231 of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
232 where  is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
233 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
234 standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC
235 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
236 specified by the use of the following words:
237 ”Replacement” means that the clause or subclause of the general standard or applicable
238 collateral standard is replaced completely by the text of this particular standard.
239 “Addition” means that the text of this particular standard is additional to the requirements of
240 the general standard or applicable collateral standard.
241 “Amendment” means that the clause or subclause of the general standard or applica ble
242 collateral standard is amended as indicated by the text of this particular standard.
243 Subclauses, figures or tables which are additional to those of the general standard are
244 numbered starting from 201.101. However, due to the fact that definitions in the general
245 standard are numbered 3.1 through 3.154, additional definitions in this standard are
246 numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
247 additional items aa), bb), etc.
248 Subclauses, figures or tables which are additional to those of a collateral standard are
249 numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
250 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
251 The term “this standard” is used to make reference to the general standard, any applicable
252 collateral standards and this particular standard taken together.
253 Where there is no corresponding clause or subclause in this particular standard, the clause or
254 subclause of the general standard or applicable collateral standard, although p ossibly not
255 relevant, applies without modification; where it is intended that any part of the general

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256 standard or applicable collateral standard, although possibly relevant, is not to be applied, a
257 statement to that effect is given in this particular standard.
258 201.2 Normative references
259 NOTE Informative references are listed in the bibliography beginning on page 41.
260 Clause 2 of the general standard applies, except as follows:
261 Addition:
262 IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
263 basic safety and essential performance of high frequency surgical equipment and high
264 frequency surgical accessories
265 Amendment 1:202X
Note to National Committees: IEC 60601-2-2:2017 + Amendment 1 is scheduled as an IS by
2022-06. If this committee (IEC SC 62D / JWG9) is able to review IEC 60601-2-2:2017
Amendment 1 & update this draft standard (80601-2-58) before we submit for the CDV stage
vote we will include that version in the draft standard for the CDV vote.
266 IEC 60601-2-22:2019, Medical electrical equipment – Part 2-22: Particular requirements for
267 the basic safety and essential performance of surgical, cosmetic, therapeutic an d diagnostic
268 laser equipment
269 Amendment 1:202X(?)
Note to National Committees: It is unclear when IEC 60601-2-22:2019 + Amendment 1 is
scheduled to be drafted (no project open) to align with the general standard IEC 60601-1
Amendments. If this committee (IEC SC 62D / JWG9) is able to review IEC 60601-2-22:2019
+ Amendment 1 & update this draft standard (80601-2-58) before the CDV stage vote we will
include that version in the draft standard for the CDV vote.
270 CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance
271 characteristics – Limits and methods of measurement
272 Amendment 1:2016
273 Amendment 2:2019
274 ISO 15004-2:2007, Ophthalmic instruments — Fundamental requirements and test methods
275 — Part 2: Light hazard protection
276 ISO 11607-1:2019, Packaging for terminally sterilized medical devices – Part 1: Requirements
277 for materials, sterile barrier systems and packaging systems
278 ISO 11607-2:2019, Packaging for terminally sterilized medical devices – Part 2: Validation
279 requirements for forming, sealing and assembly processes
280 ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and
281 performance of medical devices — Part 1: General essential principles and additional specific
282 essential principles for all non-IVD medical devices and guidance on the selection of
283 standards
284 ISO 17664:2017, Sterilization of medical devices – Information to be provided by the
285 manufacturer for the processing of resterilizable medical devices

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286 201.3 Terms and definitions
287 For the purposes of this document, the terms and definitions given in ISO 16142-1:2016, IEC
288 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and the
289 following apply.
290 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
291 — IEC Electropedia: available at http://www.electropedia.org/
292 — ISO Online browsing platform: available at http://www.iso.org/obpNOTE An index of defined
293 terms is found beginning on page 42.
294 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause
295 3, applies, except as follows:
296 Addition:
297 201.3.201
298 ASPIRATION
299 drawing fluid or gas out of the eye by use of suction
300 201.3.202
301 DIATHERMY
302 surgical technique using high frequency (HF) electrical currents to stop bleeding in tissue
303 Note 1 to entry: Diathermy is used, for example, to coagulate blood or bind tissues together.
304 Note 2 to entry: The terms “cautery” or “coagulation” have also been used in this context.
305 201.3.203
306 DRAIN CONTAINER
307 sealed container (or bag) in which aspirated fluid is collected
308
309 201.3.204
310 ENDOILLUMINATOR
311 device consisting of a light source and an associated fibre optic light guide that is intended for
312 insertion into the eye to illuminate any portion of the interior of the eye
313 [SOURCE: ISO 15004-2:2007, 3.15]
314
315 201.3.205
316 HANDPIECE
317 PROBE
318 handheld APPLIED PART, an ACCESSORY of LENS REMOVAL DEVICES or VITRECTOMY DEVICES
319 201.3.206
320 LASER
321 any device which can be made to produce or amplify electromagnetic radiation in the
322 wavelength range from 180 nm to 1 mm primarily by the process of controlled stimulated
323 emission
324 [SOURCE: IEC 60825-1: 2014, 3.44 [4]]
325 201.3.207
326 LASER FRAGMENTATION
327 method by which the lens is broken into small fragments using LASER energy

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328 201.3.208
329 LENS REMOVAL
330 removal of unwanted lens tissue
331 2
...