IEC 80601-2-58:2024

IEC 80601-2-58
Edition 3.0 2024-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews, graphical symbols and the glossary.
committee, …). It also gives information on projects, replaced With a subscription you will always have access to up to date
and withdrawn publications. content tailored to your needs.

IEC Just Published - webstore.iec.ch/justpublished
Electropedia - www.electropedia.org
Stay up to date on all new IEC publications. Just Published
The world's leading online dictionary on electrotechnology,
details all new publications released. Available online and once
containing more than 22 500 terminological entries in English
a month by email.
and French, with equivalent terms in 25 additional languages.

Also known as the International Electrotechnical Vocabulary
IEC Customer Service Centre - webstore.iec.ch/csc
(IEV) online.
If you wish to give us your feedback on this publication or need

further assistance, please contact the Customer Service
Centre: sales@iec.ch.
IEC 80601-2-58
Edition 3.0 2024-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.70 ISBN 978-2-8322-8499-5

– 2 – IEC 80601-2-58:2024 RLV © IEC 2024
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements. 12
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS. 15
201.11 Protection against excessive temperatures and other HAZARDS . 15
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 * ME SYSTEMS . 26
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 26
202 Electromagnetic disturbances – Requirements and tests . 26
Annexes . 28
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 28
Annex D (informative) Symbols on marking (See Clause 7) . 29
Annex AA (informative) Particular guidance and rationale . 31
Annex BB (informative) Reference to the general safety and performance
requirements . 37
Bibliography . 39
Index of defined terms . 41

Figure 201.101 – Test method for gravity fed IRRIGATION . 16
Figure 201.102 – Test method for pressurized IRRIGATION . 17
Figure 201.103 – Test method for ASPIRATION pressure measurement/display accuracy . 18
Figure 201.104 – Test method for ultrasonic velocity of TIP accuracy . 21
Figure 201.105 – Partial shadow, and camera field of view relative to TIP . 22

Table 201.101 – Key of symbols for Figure 201.101 to Figure 201.103 . 18
Table 201.C.101 – ACCOMPANYING DOCUMENTS, instructions for use of LENS REMOVAL
DEVICES and VITRECTOMY DEVICES or their parts . 28
Table D.4 – LENS REMOVAL and VITRECTOMY symbols . 29
Table BB.1 – Correspondence between this document and the general safety and
performance requirements . 34

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition IEC 80601-2-58:2014+AMD1:2016 CSV. A vertical bar
appears in the margin wherever a change has been made. Additions are in green text,
deletions are in strikethrough red text.

– 4 – IEC 80601-2-58:2024 RLV © IEC 2024
IEC 80601-2-58 has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems, in co-operation with ISO subcommittee SC 7: Ophthalmic optics and instruments, of
ISO technical committee 172: Optics and photonics. It is an International Standard.
It is published as a double logo standard.
This third edition cancels and replaces the second edition published in 2014 and its
Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
b) the update of collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-
1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other
collateral standards;
c) the update of normative references;
d) the addition of a new requirement for particulate matter from APPLIED PARTS in 201.9.5.101;
e) the addition of the shadow light method in 201.12.1.101.7;
f) the clarification of test conditions for EMC requirements in 202.7.1.2;
g) the update of Table D.4 references to include specific IEC references to the symbols and
deletion of Annex AA, 201.7.6.101;
h) the addition to Annex AA of 201.12.1.101.7;
i) the inclusion of a new annex to address the relevant general safety and performance
(Annex BB);
requirements of European regulation (EU) 2017/745 [1]
j) the removal of all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/2096/FDIS 62D/2110/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, the following print types are used:
– requirements and definitions: roman type.
– test spe
...