IEC 80601-2-58:2024
(Main)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
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
IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005.
IEC 80601-2-58:2024 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) updating 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) updated normative references;
d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101;
e) adding the shadow light method in 201.12.1.101.7;
f) clarify test conditions for EMC requirements in 202.7.1.2;
g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”;
h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB);
i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.
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
L'IEC 80601-2-58:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des DISPOSITIFS DE RETRAIT DU CRISTALLIN et des DISPOSITIFS DE VITRECTOMIE pour la chirurgie ophtalmique (comme cela est défini en 201.3.209 et 201.3.217) et des ACCESSOIRES liés qui peuvent être raccordés à ces APPAREILS ELECTROMEDICAUX, désignés ci-après comme APPAREILS EM. Lorsqu’un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si ce n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l’exception du 7.2.13 de l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD2:2020 et du 8.4.1 de l’IEC 60601-1:2005.
L'IEC 80601-2-58:2024 le et remplace la deuxième édition parue en 2014 et son Amendement 1:2016. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) alignement de la présente norme particulière sur la base des amendements de l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et de l'IEC 60601-1:2005/AMD2:2020;
b) mise à jour des références à l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 et aux normes particulières et collatérales pour les aligner sur les amendements de l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 et des autres normes collatérales;
c) mise à jour des références normatives;
d) ajout d’une nouvelle exigence relative aux corps solides qui proviennent des PARTIES APPLIQUEES dans le 201.9.5.101;
e) ajout de la méthode de la lumière rasante dans le 201.12.1.101.7;
f) clarification des conditions d’essai pour les exigences de CEM dans le 202.7.1.2;
g) mise à jour des références du Tableau D.4 pour inclure les références IEC spécifiques aux symboles et supprimer le "201.7.6.101" existant de l’"Annexe AA";
h) inclusion d’une nouvelle annexe pour couvrir les exigences générales pertinentes en matière de sécurité et de performances du règlement européen (UE) 2017/745 (Annexe BB).
i) suppression de toutes les références à la méthode de RETRAIT DU CRISTALLIN au moyen de la FRAGMENTATION PAR LIQUEFACTION.
General Information
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Standards Content (Sample)
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
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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
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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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
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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
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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
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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 specifications: italic type.
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
___________
Numbers in square brackets refer to the Bibliography.
– TERMS DEFINED IN CLAUSE 3 OF IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or", so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 and IEC 80601 series, published under the general title
Medical electrical equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IMPORTANT – The "colour inside" logo on the cover page of this document 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.
– 6 – IEC 80601-2-58:2024 RLV © IEC 2024
INTRODUCTION
LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used widely in ophthalmology to perform
anterior-segment and posterior-segment surgery on the human eye. Commercial use of these
MEDICAL ELECTRICAL EQUIPMENT devices began in the early 1970s. This document defines
particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES
and VITRECTOMY DEVICES, comprising an equipment console, surgical HANDPIECES and
ACCESSORIES connected to this ME EQUIPMENT.
In many parts of the world LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used in
combination by ophthalmic surgeons to perform combined anterior-segment (LENS REMOVAL)
and posterior-segment (vitreoretinal) surgical PROCEDURES to maximize surgical outcomes. For
this reason both LENS REMOVAL DEVICES and VITRECTOMY DEVICES are covered in this document.
As all particular standards in the IEC 60601-1 series are based on the general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, the
user of this document is reminded that RISK MANAGEMENT plays an important role in the use of
this particular standard. Compliance with the requirements of this document should be
documented recorded in the RISK MANAGEMENT FILE to ensure the HAZARDS associated with the
product have been considered fully.
Refer to foreword of this document for list of significant technical changes with respect to the
previous edition.
INTRODUCTION TO THE AMENDMENT
This amendment modifies the content of the second edition of IEC 80601-2-58 published in 2014.
This Amendment constitutes a technical revision.
This amendment includes the following significant technical changes with respect to the second
edition:
a) integration of updated definition of ESSENTIAL PERFORMANCE and updating the ESSENTIAL
PERFORMANCE analysis;
b) undating collateral and general standard references to align with amendments to the general
standard and other collateral standards;
c) addition of symbols to standard;
d) update of EMC requirements.
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
201.1 Scope, object and related standards
Clause 1 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208209
and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL
EQUIPMENT, hereafter referred to as ME EQUIPMENT.
ME EQUIPMENT only, or to
If a clause or subclause is specifically intended to be applicable to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this document are not covered by specific requirements in this document except
in 7.2.13 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020 and 8.4.1 of the general
standard IEC 60601-1:2005.
NOTE See also 4.2 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic
ACCESSORIES that can be
surgery (as defined in 201.3.208209 and 201.3.217) and associated
connected to the ME EQUIPMENT and are to shall be tested together or individually.
NOTE This document has been prepared to address the relevant general safety and performance requirements of
European regulation (EU) 2017/745 [1] as indicated in Annex BB.
201.1.3 * Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of the
general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, and Clause 201.2.
___________
The general standard is IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
– 8 – IEC 80601-2-58:2024 RLV © IEC 2024
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply as modified in Clause 202.
IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021[2],
IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and IEC 60601-1-9:2007/AMD2:2020[3],
IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-10:
2007/AMD2:2020[4], IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020[5], and
IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020[6] do not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards specify BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for the particular ME EQUIPMENT and ME SYSTEMS. Particular standards may modify,
replace or delete requirements contained in the general standard IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and applicable collateral
standards as appropriate for the particular ME EQUIPMENT and ME SYSTEMS under consideration,
and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of
a particular standard takes priority over the general standard IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and applicable collateral
standards.
For brevity, IEC 60601-1 is referred to in this particular standard as the “general standard”.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to that of the general
standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 with the prefix "201" (e.g. 201.1 in this document addresses the
content of Clause 1 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020) or applicable collateral standard with the prefix "20x" where
x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this document
addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 addresses
the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text
of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of the general
standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of the general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through 3.139154, additional definitions in
this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB,
etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term “this standard” is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of the general standard
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly relevant, is not to be applied, a statement to
that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 39.
Clause 2 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
Replacement:
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral standard: Electromagnetic disturbances – Requirements
and tests
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-2:2017/AMD1:2023
IEC 60601-2-22:2019, Medical electrical equipment – Part 2-22: Particular requirements for
basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment
CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics – Limits and methods of measurement
CISPR 11:2015/AMD1:2016
CISPR 11:2015/AMD2:2019
ISO 11607-1:2006/AMD1:20142019, Packaging for terminally sterilized medical devices – Part
1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006/AMD1:20142019, Packaging for terminally sterilized medical devices – Part
2: Validation requirements for forming, sealing and assembly processes
ISO 17664:20042017, Sterilization of medical devices Processing of health care products –
Information to be provided by the medical device manufacturer for the processing of
resterilizable medical devices
– 10 – IEC 80601-2-58:2024 RLV © IEC 2024
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 41.
Addition:
201.3.201
ASPIRATION
drawing fluid or gas out of the eye by use of suction
201.3.202
DIATHERMY
surgical technique using high frequency (HF) electrical currents to stop bleeding in tissue
Note 1 to entry: DIATHERMY is used, for example, to coagulate blood or bind tissues together.
Note 2 to entry: The terms "cautery" or "coagulation" have also been used in this context.
201.3.203
DRAIN CONTAINER
sealed container (or bag) in which aspirated fluid is collected
201.3.204
ENDOILLUMINATOR
device consisting of a light source and an associated fibre optic light guide that is intended for
insertion into the eye to illuminate any portion of the interior of the eye
[SOURCE: ISO 15004-2:2007, 3.1.5 [7]]
201.3.204205
HANDPIECE
PROBE
handheld APPLIED PART, an ACCESSORY of LENS REMOVAL DEVICES or VITRECTOMY DEVICES
201.3.205206
LASER
any device which can be made to produce or amplify electromagnetic radiation in the
wavelength range from 180 nm to 1 mm primarily by the PROCESS of controlled stimulated
emission
[SOURCE: IEC 60825-1:2014, 3.44 [8]]
201.3.206207
LASER FRAGMENTATION
method by which the lens is broken into small fragments using LASER energy
201.3.207208
LENS REMOVAL
removal of unwanted lens tissue
201.3.208209
LENS REMOVAL DEVICE
ME EQUIPMENT or ME SYSTEM designed to remove lens material which incorporates an IRRIGATION
and ASPIRATION function, and a mechanism for LENS REMOVAL such as PHACOFRAGMENTATION,
LIQUEFACTION, or LASER FRAGMENTATION
Note 1 to entry: These devices may can also be used for other ocular surgical purposes.
201.3.209
LIQUEFACTION FRAGMENTATION
LIQUEFACTION
method by which the lens is broken into small fragments by means of pulses of ophthalmic
IRRIGATION solution
201.3.210
OCULAR IRRIGATION
IRRIGATION
introduction of a liquid into the eye
Note 1 to entry: The term "infusion" has also been used in this context
201.3.211
PHACOFRAGMENTATION
method by which the lens is broken into small fragments using energy such as from ultrasonic
devices
Note 1 to entry: Refer to the definition of LENS REMOVAL DEVICE in 201.3.208209.
Note 2 to entry: Historically PHACOFRAGMENTATION (term is also identified as phacoemulsification) has been a
surgical PROCEDURE that uses ultrasonic energy to fragment (or emulsify) a cataractous lens and removes the lens
material through a small incision. Recently, other emerging energy modalities, including LASER FRAGMENTATION and
LIQUEFACTION, have also been utilized in the removal of the cataractous lens through a small incision.
201.3.212
PHOTORETINITIS
retinal injury resulting from a very intense retinal radiant exposure
201.3.213
PRIME
PRIMING
pre-operative setup PROCEDURE to fill TUBING SET (fluid path) with ophthalmic IRRIGATION solution
201.3.214
TIP
hollow needle-like device that is attached to a HANDPIECE
201.3.215
TUBING SET
set of tubes to contain fluid, designed to provide IRRIGATION to the eye and ASPIRATION from the
eye
201.3.216
VITRECTOMY
surgical PROCEDURE to remove vitreous humour, membranes, blood, lens tissue and other
material from the eye, involving IRRIGATION, ASPIRATION and vitreous cutting
Note 1 to entry: The PROCEDURE may also include illumination, DIATHERMY, fluid/gas exchanges, and injection of
viscous fluids.
– 12 – IEC 80601-2-58:2024 RLV © IEC 2024
201.3.217
VITRECTOMY DEVICE
ME EQUIPMENT or ME SYSTEM used to perform VITRECTOMY
Note 1 to entry: These devices may can also be used for other ocular surgical purposes.
201.4 General requirements
Clause 4 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.4.2.1 Introduction to RISK MANAGEMENT
Addition:
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020,
and IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601-1-8:2006/AMD2:2020 shall be assessed for applicability through the RISK
MANAGEMENT PROCESS. Compliance shall be determined and documented in the RISK
MANAGEMENT FILE.
201.4.3 * ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 General
For LENS REMOVAL DEVICES and VITRECTOMY DEVICES, no ESSENTIAL PERFORMANCE has been
identified in general. If the LENS REMOVAL DEVICES and VITRECTOMY DEVICES have functions other
MANUFACTURER shall identify which of these functions
than those specified in Clause 201.12, the
of the ME EQUIPMENT and ME SYSTEMS is ESSENTIAL PERFORMANCE.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
Additional subclause:
201.4.101 * Additional functions
If there is a DIATHERMY function used for the LENS REMOVAL DEVICE and VITRECTOMY DEVICE, that
function shall meet the requirements of IEC 60601-2-2:2017 and
IEC 60601-2-2:2017/AMD1:2023.
If the ME EQUIPMENT includes a LASER function, that function shall meet the requirements of
IEC 60601-2-22:2019.
If there is an illumination function used to illuminate the eye during surgery that is part of the
ME EQUIPMENT or ME SYSTEM, then that portion of the ME EQUIPMENT or ME SYSTEM shall meet
201.12.4.101.5.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
Additional subclause:
201.7.6.101 * Additional symbols
Addition:
Symbols for LENS REMOVAL and VITRECTOMY.
If symbols for LENS REMOVAL DEVICES and VITRECTOMY DEVICES that have functions such as
DIATHERMY, FRAGMENTATION, LIQUEFACTION FRAGMENTATION PHACOFRAGMENTATION, VITRECTOMY,
and illumination are used, they shall be based on the recommended symbols of Table D.4 and
be on the device or near the connection point of the function.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally include the following warning and safety notices:
a) a warning to use only recommended TUBING SET(s);
b) if an electrically adjustable ophthalmic IRRIGATION solution support pole is used, a warning
not to modify pole height or manually force the pole height because this could cause
incorrect indication of bottle height and PATIENT injury;
c) a warning never to intentionally modify HANDPIECES or TIPS (e.g. do not bend, cut, or engrave
them) as they could break or malfunction;
d) a warning to the OPERATOR not to touch an activated ultrasonic HANDPIECE TIP, as injuries
could occur;
e) if applicable, warnings related to lamp replacement (e.g. RISK of injury, ratings of lamp,
damage to lamp, damage to machine, etc.);
f) if applicable, a warning to the OPERATOR that care should be taken to avoid concentrating
the output of an illumination module on a small area of the retina for unnecessarily prolonged
periods of time due to the potential for PHOTORETINITIS and serious permanent PATIENT injury;
g) if applicable, a warning to the OPERATOR that inadvertent activation of functions that are
intended for PRIMING or tuning HANDPIECES while the HANDPIECE is in the eye can create a
HAZARDOUS SITUATION that could result in PATIENT injury;
h) where gravity is relevant to performance, the ophthalmic IRRIGATION solution source shall be
at or above the PATIENT’s eye level;
i) a warning to the OPERATOR to ensure sufficient volume of IRRIGATION solution for the
PROCEDURE. The level should be monitored during the PROCEDURE;
j) if applicable, a warning to the OPERATOR to ensure that the maximum capacity of the DRAIN
CONTAINER is not exceeded as this could cause a HAZARDOUS SITUATION to the PATIENT.
201.7.9.2.8 Start-up PROCEDURE
Addition:
– 14 – IEC 80601-2-58:2024 RLV © IEC 2024
The instructions for use shall include instructions to perform functional checks of the system
before the first use of the day.
201.7.9.2.9 Operating instructions
Addition:
The operating instructions shall additionally include:
a) if applicable, instructions regarding loading, PRIMING, changing, and reloading the TUBING
SET(s), and the TUBING SET(s) change interval to maintain the specified performance;
b) if applicable, instructions regarding the use of clamps on a TUBING SET, the avoidance of
ophthalmic IRRIGATION solution free flow conditions, and the PROCEDURE to be followed when
changing the ophthalmic IRRIGATION solution source;
c) instructions regarding securely attaching plugs, HANDPIECE cables and other connectors.
201.7.9.2.12 Cleaning, disinfection and sterilization
Addition:
For parts that are resterilizable, the information for processing shall be in accordance with
ISO 17664:20042017. This information shall be provided to the RESPONSIBLE ORGANIZATION or
the OPERATOR [9].
201.7.9.2.13 Maintenance
Addition:
The instructions for use shall provide the OPERATOR or RESPONSIBLE ORGANIZATION with a
recommendation to inspect all HANDPIECE cables and any cords on a regular basis and a
recommendation as to the action to take if damage (e.g. exposed wire, nicks in the insulation,
deformation, etc.) is observed.
201.7.9.3.1 General
Addition:
For ME EQUIPMENT and ME SYSTEMS that have a DIATHERMY function the technical description
shall include reference to group 2 for the device.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS
Clause 9 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
Additional subclause:
201.9.5.101 Particulate matter from APPLIED PARTS
Particulate matter from APPLIED PARTS shall be assessed for acceptable size and quantity
through the RISK MANAGEMENT PROCESS. Compliance shall be determined and documented in
the RISK MANAGEMENT FILE.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.10.6 Infrared radiation
Refer to clause 201.12.4.101.5, item 2).
201.10.7 Ultraviolet radiation
Refer to clause 201.12.4.101.5, item 1).
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.11.1.2 Temperature of APPLIED PARTS
201.11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT
Replacement:
HANDPIECES for DIATHERMY, PHACOFRAGMENTATION, LASER and LIQUEFACTION, VITRECTOMY are
considered to be APPLIED PARTS intended to supply heat to a PATIENT.
The temperature or clinical effects shall be determined and documented in the RISK MANAGEMENT
FILE.
201.11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
Addition:
The packaging for terminally sterilized ACCESSORIES for LENS REMOVAL DEVICES and VITRECTOMY
DEVICES shall comply with the requirements of ISO 11607-1:2006/AMD1:2014.2019. Validation
requirements for forming, sealing, and assembly processes for this packaging shall be
consistent with ISO 11607-2:2006/AMD1:20142019.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.12.1 Accuracy of controls and instruments
Additional subclauses:
– 16 – IEC 80601-2-58:2024 RLV © IEC 2024
201.12.1.101 Additional accuracy of controls and instruments requirements
NOTE Additional requirements for accuracy of controls and instruments are detailed in 201.12.1.101.1 to
201.12.1.101.5, 201.12.1.101.7 and 201.12.1.101.98.
201.12.1.101.1 Accuracy of static IRRIGATION pressure
Static IRRIGATION pressure output shall not deviate from the indicated setting on the LENS
REMOVAL DEVICES and VITRECTOMY DEVICES by more than ± 20 % or ± 10 mmHg (± 1,3 kPa)
whichever is greater for a specific device in a defined configuration (see 201.12.4.101.1 for
hazardous output limit).
Compliance is checked by applying the relevant test method(s) 1 and/or 2:
a) Test method 1 (gravity fed IRRIGATION)
1) Set the test environment temperature to 25 °C ± 5 °C.
2) Install the TUBING SET(s) and PRIME the device in accordance with the MANUFACTURER’s
instructions for use.
3) Zero the pressure meter reading. Connect the pressure meter to the end of the
IRRIGATION tubing and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.101.
4) Initiate the flow of fluid in accordance with the MANUFACTURER’s instructions for use.
NOTE 1 If the system uses IV pole height without a claim to IRRIGATION pressure (i.e., if there is no defined
PATIENT eye level), then zero the pressure sensor reading with the IV pole at zero while the pressure sensor is
at a simulated PATIENT eye level. Use the same zero point (simulated PATIENT eye level) for the verification of
the hazardous output IRRIGATION pressure in 201.12.4.101.1.
5) Set the gravity feed reservoir height to 0 cm or the lowest setting and record the pressure
meter reading after 5 s.
6) Increase the reservoir height by 20 cm and wait for 5 s and record the pressure meter
reading.
7) Repeat step 6 until the maximum reservoir height is reached.
8) Record the pressure meter reading at the maximum reservoir height.
9) Repeat the readings at the heights used in steps 5, 6 and 7 as the height is decreased
and wait for 5 s and record the pressure meter reading at each point.
10) Confirm that all the readings are within the stated range.
For key, see Table 201.101.
Figure 201.101 – Test method for gravity fed IRRIGATION
b) Test method 2 (pressurized IRRIGATION)
1) Set the test environment temperature to 25 °C ± 5 °C.
2) Install the TUBING SET(S) and PRIME the device in accordance with the MANUFACTURER’S
instructions for use.
3) Zero the pressure meter (PM) reading. Connect the pressure meter to the end of the
IRRIGATION tubing and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.102.
4) Initiate the flow of fluid in accordance with the MANUFACTURER’s instructions for use.
5) Set the test IRRIGATION pressure to 0 mmHg (0 kPa) or lowest setting and record
pressure meter reading after 5 s.
6) Increase the test pressure values by 20 mmHg (2,7 kPa).
7) Wait for 5 s and record pressure meter reading.
8) Repeat steps 6) and 7) for test pressure setting in 20 mmHg (2,7 kPa) increments until
the maximum pressure se
...
IEC 80601-2-58
Edition 3.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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
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IEC 80601-2-58
Edition 3.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.70 ISBN 978-2-8322-8132-1
– 2 – IEC 80601-2-58:2024 © 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 . 9
201.4 General requirements. 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
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. 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 * ME SYSTEMS . 24
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
202 Electromagnetic disturbances – Requirements and tests . 25
Annexes . 26
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 26
Annex D (informative) Symbols on marking (See Clause 7) . 27
Annex AA (informative) Particular guidance and rationale . 28
Annex BB (informative) Reference to the general safety and performance
requirements . 34
Bibliography . 36
Index of defined terms . 38
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 . 26
Table D.4 – LENS REMOVAL and VITRECTOMY symbols . 27
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
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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.
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.
– 4 – IEC 80601-2-58:2024 © IEC 2024
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
requirements of European regulation (EU) 2017/745 [1] (Annex BB);
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 specifications: italic type.
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
___________
Numbers in square brackets refer to the Bibliography.
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or", so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 and IEC 80601 series, published under the general title
Medical electrical equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
– 6 – IEC 80601-2-58:2024 © IEC 2024
INTRODUCTION
LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used widely in ophthalmology to perform
anterior-segment and posterior-segment surgery on the human eye. Commercial use of these
MEDICAL ELECTRICAL EQUIPMENT devices began in the early 1970s. This document defines
particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES
and VITRECTOMY DEVICES, comprising an equipment console, surgical HANDPIECES and
ACCESSORIES connected to this ME EQUIPMENT.
In many parts of the world LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used in
combination by ophthalmic surgeons to perform combined anterior-segment (LENS REMOVAL)
and posterior-segment (vitreoretinal) surgical PROCEDURES to maximize surgical outcomes. For
this reason both LENS REMOVAL DEVICES and VITRECTOMY DEVICES are covered in this document.
As all particular standards in the IEC 60601-1 series are based on IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, the user of this document
is reminded that RISK MANAGEMENT plays an important role in the use of this particular standard.
Compliance with the requirements of this document should be recorded in the RISK MANAGEMENT
FILE to ensure the HAZARDS associated with the product have been considered fully.
Refer to foreword of this document for list of significant technical changes with respect to the
previous edition.
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
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and
ACCESSORIES that can be connected to this MEDICAL ELECTRICAL
201.3.217) and associated
EQUIPMENT, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this document are not covered by specific requirements in this document except
in 7.2.13 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020 and 8.4.1 of IEC 60601-
1:2005.
NOTE See also 4.2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic
surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be
connected to the ME EQUIPMENT and shall be tested together or individually.
NOTE This document has been prepared to address the relevant general safety and performance requirements of
European regulation (EU) 2017/745 [1] as indicated in Annex BB.
201.1.3 * Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, and
Clause 201.2.
– 8 – IEC 80601-2-58:2024 © IEC 2024
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 apply as modified in Clause 202.
IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021[2],
IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and IEC 60601-1-9:2007/AMD2:2020[3],
IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-10:
2007/AMD2:2020[4], IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020[5], and
IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020[6] do not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards specify BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for the particular ME EQUIPMENT and ME SYSTEMS. Particular standards may modify,
replace or delete requirements contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
and IEC 60601-1:2005/AMD2:2020 and applicable collateral standards as appropriate for the
particular ME EQUIPMENT and ME SYSTEMS under consideration. A requirement of a particular
standard takes priority over IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and applicable collateral standards.
The numbering of clauses and subclauses of this document corresponds to that of the
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) or
applicable collateral standard with the prefix "20x" where x is the final digit(s) of the collateral
standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are specified by the use of
the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.154, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 36.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-2:2017/AMD1:2023
IEC 60601-2-22:2019, Medical electrical equipment – Part 2-22: Particular requirements for
basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment
CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics – Limits and methods of measurement
CISPR 11:2015/AMD1:2016
CISPR 11:2015/AMD2:2019
ISO 11607-1:2019, Packaging for terminally sterilized medical devices – Part 1: Requirements
for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019, Packaging for terminally sterilized medical devices – Part 2: Validation
requirements for forming, sealing and assembly processes
ISO 17664:2017, Processing of health care products – Information to be provided by the
medical device manufacturer for the processing of medical devices
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 38.
Addition:
201.3.201
ASPIRATION
drawing fluid or gas out of the eye by use of suction
– 10 – IEC 80601-2-58:2024 © IEC 2024
201.3.202
DIATHERMY
surgical technique using high frequency (HF) electrical currents to stop bleeding in tissue
Note 1 to entry: DIATHERMY is used, for example, to coagulate blood or bind tissues together.
Note 2 to entry: The terms "cautery" or "coagulation" have also been used in this context.
201.3.203
DRAIN CONTAINER
sealed container (or bag) in which aspirated fluid is collected
201.3.204
ENDOILLUMINATOR
device consisting of a light source and an associated fibre optic light guide that is intended for
insertion into the eye to illuminate any portion of the interior of the eye
[SOURCE: ISO 15004-2:2007, 3.1.5 [7]]
201.3.205
HANDPIECE
PROBE
handheld APPLIED PART, an ACCESSORY of LENS REMOVAL DEVICES or VITRECTOMY DEVICES
201.3.206
LASER
any device which can be made to produce or amplify electromagnetic radiation in the
wavelength range from 180 nm to 1 mm primarily by the PROCESS of controlled stimulated
emission
[SOURCE: IEC 60825-1:2014, 3.44 [8]]
201.3.207
LASER FRAGMENTATION
method by which the lens is broken into small fragments using LASER energy
201.3.208
LENS REMOVAL
removal of unwanted lens tissue
201.3.209
LENS REMOVAL DEVICE
ME EQUIPMENT or ME SYSTEM designed to remove lens material which incorporates an IRRIGATION
and ASPIRATION function, and a mechanism for LENS REMOVAL such as PHACOFRAGMENTATION, or
LASER FRAGMENTATION
Note 1 to entry: These devices can also be used for other ocular surgical purposes.
201.3.210
OCULAR IRRIGATION
IRRIGATION
introduction of a liquid into the eye
Note 1 to entry: The term "infusion" has also been used in this context
201.3.211
PHACOFRAGMENTATION
method by which the lens is broken into small fragments using energy such as from ultrasonic
devices
Note 1 to entry: Refer to the definition of LENS REMOVAL DEVICE in 201.3.209.
Note 2 to entry: Historically PHACOFRAGMENTATION (term is also identified as phacoemulsification) has been a
surgical PROCEDURE that uses ultrasonic energy to fragment (or emulsify) a cataractous lens and removes the lens
material through a small incision. Recently, other emerging energy modalities, including LASER FRAGMENTATION, have
also been utilized in the removal of the cataractous lens through a small incision.
201.3.212
PHOTORETINITIS
retinal injury resulting from a very intense retinal radiant exposure
201.3.213
PRIME
PRIMING
pre-operative setup PROCEDURE to fill TUBING SET (fluid path) with ophthalmic IRRIGATION solution
201.3.214
TIP
hollow needle-like device that is attached to a HANDPIECE
201.3.215
TUBING SET
set of tubes to contain fluid, designed to provide IRRIGATION to the eye and ASPIRATION from the
eye
201.3.216
VITRECTOMY
surgical PROCEDURE to remove vitreous humour, membranes, blood, lens tissue and other
material from the eye, involving IRRIGATION, ASPIRATION and vitreous cutting
Note 1 to entry: The PROCEDURE may also include illumination, DIATHERMY, fluid/gas exchanges, and injection of
viscous fluids.
201.3.217
VITRECTOMY DEVICE
ME EQUIPMENT or ME SYSTEM used to perform VITRECTOMY
Note 1 to entry: These devices can also be used for other ocular surgical purposes.
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.4.2.1 Introduction to RISK MANAGEMENT
Addition:
IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020,
and IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601-1-8:2006/AMD2:2020 shall be assessed for applicability through the RISK
MANAGEMENT PROCESS. Compliance shall be determined and documented in the RISK
MANAGEMENT FILE.
– 12 – IEC 80601-2-58:2024 © IEC 2024
201.4.3 * ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 General
For LENS REMOVAL DEVICES and VITRECTOMY DEVICES, no ESSENTIAL PERFORMANCE has been
identified in general. If the LENS REMOVAL DEVICES and VITRECTOMY DEVICES have functions other
than those specified in Clause 201.12, the MANUFACTURER shall identify which of these functions
of the ME EQUIPMENT and ME SYSTEMS is ESSENTIAL PERFORMANCE.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
Additional subclause:
201.4.101 * Additional functions
If there is a DIATHERMY function used for the LENS REMOVAL DEVICE and VITRECTOMY DEVICE, that
function shall meet the requirements of IEC 60601-2-2:2017 and
IEC 60601-2-2:2017/AMD1:2023.
If the ME EQUIPMENT includes a LASER function, that function shall meet the requirements of
IEC 60601-2-22:2019.
If there is an illumination function used to illuminate the eye during surgery that is part of the
ME EQUIPMENT or ME SYSTEM, then that portion of the ME EQUIPMENT or ME SYSTEM shall meet
201.12.4.101.5.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
Additional subclause:
201.7.6.101 Additional symbols
Symbols for LENS REMOVAL and VITRECTOMY.
If symbols for LENS REMOVAL DEVICES and VITRECTOMY DEVICES that have functions such as
DIATHERMY, PHACOFRAGMENTATION, VITRECTOMY, and illumination are used, they shall be based
on the recommended symbols of Table D.4 and be on the device or near the connection point
of the function.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally include the following warning and safety notices:
a) a warning to use only recommended TUBING SET(s);
b) if an electrically adjustable ophthalmic IRRIGATION solution support pole is used, a warning
not to modify pole height or manually force the pole height because this could cause
incorrect indication of bottle height and PATIENT injury;
c) a warning never to intentionally modify HANDPIECES or TIPS (e.g. do not bend, cut, or engrave
them) as they could break or malfunction;
d) a warning to the OPERATOR not to touch an activated ultrasonic HANDPIECE TIP, as injuries
could occur;
e) if applicable, warnings related to lamp replacement (e.g. RISK of injury, ratings of lamp,
damage to lamp, damage to machine, etc.);
f) if applicable, a warning to the OPERATOR that care should be taken to avoid concentrating
the output of an illumination module on a small area of the retina for unnecessarily prolonged
periods of time due to the potential for PHOTORETINITIS and serious permanent PATIENT injury;
g) if applicable, a warning to the OPERATOR that inadvertent activation of functions that are
intended for PRIMING or tuning HANDPIECES while the HANDPIECE is in the eye can create a
HAZARDOUS SITUATION that could result in PATIENT injury;
h) where gravity is relevant to performance, the ophthalmic IRRIGATION solution source shall be
at or above the PATIENT’s eye level;
i) a warning to the OPERATOR to ensure sufficient volume of IRRIGATION solution for the
PROCEDURE. The level should be monitored during the PROCEDURE;
j) if applicable, a warning to the OPERATOR to ensure that the maximum capacity of the DRAIN
CONTAINER is not exceeded as this could cause a HAZARDOUS SITUATION to the PATIENT.
201.7.9.2.8 Start-up PROCEDURE
Addition:
The instructions for use shall include instructions to perform functional checks of the system
before the first use of the day.
201.7.9.2.9 Operating instructions
Addition:
The operating instructions shall additionally include:
a) if applicable, instructions regarding loading, PRIMING, changing, and reloading the TUBING
SET(s), and the TUBING SET(s) change interval to maintain the specified performance;
b) if applicable, instructions regarding the use of clamps on a TUBING SET, the avoidance of
ophthalmic IRRIGATION solution free flow conditions, and the PROCEDURE to be followed when
changing the ophthalmic IRRIGATION solution source;
c) instructions regarding securely attaching plugs, HANDPIECE cables and other connectors.
201.7.9.2.12 Cleaning, disinfection and sterilization
Addition:
For parts that are resterilizable, the information for processing shall be in accordance with
ISO 17664:2017. This information shall be provided to the RESPONSIBLE ORGANIZATION or the
OPERATOR [9].
– 14 – IEC 80601-2-58:2024 © IEC 2024
201.7.9.2.13 Maintenance
Addition:
The instructions for use shall provide the OPERATOR or RESPONSIBLE ORGANIZATION with a
recommendation to inspect all HANDPIECE cables and any cords on a regular basis and a
recommendation as to the action to take if damage (e.g. exposed wire, nicks in the insulation,
deformation, etc.) is observed.
201.7.9.3.1 General
Addition:
For ME EQUIPMENT and ME SYSTEMS that have a DIATHERMY function the technical description
shall include reference to group 2 for the device.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS
Clause 9 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
Additional subclause:
201.9.5.101 Particulate matter from APPLIED PARTS
Particulate matter from APPLIED PARTS shall be assessed for acceptable size and quantity
through the RISK MANAGEMENT PROCESS. Compliance shall be determined and documented in
the RISK MANAGEMENT FILE.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.10.6 Infrared radiation
Refer to clause 201.12.4.101.5, item 2).
201.10.7 Ultraviolet radiation
Refer to clause 201.12.4.101.5, item 1).
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.11.1.2 Temperature of APPLIED PARTS
201.11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT
Replacement:
HANDPIECES for DIATHERMY, PHACOFRAGMENTATION, LASER, VITRECTOMY are considered to be
APPLIED PARTS intended to supply heat to a PATIENT.
The temperature or clinical effects shall be determined and documented in the RISK MANAGEMENT
FILE.
201.11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
Addition:
The packaging for terminally sterilized ACCESSORIES for LENS REMOVAL DEVICES and VITRECTOMY
DEVICES shall comply with the requirements of ISO 11607-1:2019. Validation requirements for
forming, sealing, and assembly processes for this packaging shall be consistent with
ISO 11607-2:2019.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.12.1 Accuracy of controls and instruments
Additional subclauses:
201.12.1.101 Additional accuracy of controls and instruments requirements
NOTE Additional requirements for accuracy of controls and instruments are detailed in 201.12.1.101.1 to
201.12.1.101.5, 201.12.1.101.7 and 201.12.1.101.8.
201.12.1.101.1 Accuracy of IRRIGATION pressure
IRRIGATION pressure output shall not deviate from the indicated setting on the LENS REMOVAL
and VITRECTOMY DEVICES by more than ± 20 % or ± 10 mmHg (± 1,3 kPa) whichever is
DEVICES
greater for a specific device in a defined configuration (see 201.12.4.101.1 for hazardous output
limit).
Compliance is checked by applying the relevant test method(s) 1 and/or 2:
a) Test method 1 (gravity fed IRRIGATION)
1) Set the test environment temperature to 25 °C ± 5 °C.
2) Install the TUBING SET(s) and PRIME the device in accordance with the MANUFACTURER’s
instructions for use.
3) Zero the pressure meter reading. Connect the pressure meter to the end of the
IRRIGATION tubing and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.101.
4) Initiate the flow of fluid in accordance with the MANUFACTURER’s instructions for use.
NOTE 1 If the system uses IV pole height without a claim to IRRIGATION pressure (i.e., if there is no defined
PATIENT eye level), then zero the pressure sensor reading with the IV pole at zero while the pressure sensor is
at a simulated PATIENT eye level. Use the same zero point (simulated PATIENT eye level) for the verification of
the hazardous output IRRIGATION pressure in 201.12.4.101.1.
– 16 – IEC 80601-2-58:2024 © IEC 2024
5) Set the gravity feed reservoir height to 0 cm or the lowest setting and record the pressure
meter reading after 5 s.
6) Increase the reservoir height by 20 cm and wait for 5 s and record the pressure meter
reading.
7) Repeat step 6 until the maximum reservoir height is reached.
8) Record the pressure meter reading at the maximum reservoir height.
9) Repeat the readings at the heights used in steps 5, 6 and 7 as the height is decreased
and wait for 5 s and record the pressure meter reading at each point.
10) Confirm that all the readings are within the stated range.
For key, see Table 201.101.
Figure 201.101 – Test method for gravity fed IRRIGATION
b) Test method 2 (pressurized IRRIGATION)
1) Set the test environment temperature to 25 °C ± 5 °C.
2) Install the TUBING SET(S) and PRIME the device in accordance with the MANUFACTURER’S
instructions for use.
3) Zero the pressure meter (PM) reading. Connect the pressure meter to the end of the
IRRIGATION tubing and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.102.
4) Initiate the flow of fluid in accordance with the MANUFACTURER’s instructions for use.
5) Set the test IRRIGATION pressure to 0 mmHg (0 kPa) or lowest setting and record
pressure meter reading after 5 s.
6) Increase the test pressure values by 20 mmHg (2,7 kPa).
7) Wait for 5 s and record pressure meter reading.
8) Repeat steps 6) and 7) for test pressure setting in 20 mmHg (2,7 kPa) increments until
the maximum pressure setting is reached.
9) Re
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