EN 80601-2-58:2015

SLOVENSKI STANDARD
01-september-2015
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SIST EN 80601-2-58:2009
SIST EN 80601-2-58:2009/A11:2012
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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 Horizontal Standards
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 - Normes horizontales suggérées
Ta slovenski standard je istoveten z: EN 80601-2-58:2015
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 80601-2-58

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.70 Supersedes EN 80601-2-58:2009
English Version
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 80601-2-58:2014)
Appareils électromédicaux - Partie 2-58: Exigences Medizinische elektrische Geräte - Teil 2-58: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs de retrait du cristallin et des wesentlichen Leistungsmerkmale für Geräte zur
dispositifs de vitrectomie pour la chirurgie ophtalmique Linsenentfernung und Geräte zur Glaskörperentfernung in
(IEC 80601-2-58:2014) der Augenchirurgie
(IEC 80601-2-58:2014)
This European Standard was approved by CENELEC on 2014-10-09. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 80601-2-58:2015 E
Foreword
The text of document 62D/1151/FDIS, future edition 2 of IEC 80601-2-58 prepared by
SC 62D "Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" and
SC 7 "Ophthalmic optics and instruments" of ISO/TC 172 "Optics and photonics" was submitted to the
IEC-CENELEC parallel vote and approved by CENELEC as EN 80601-2-58:2015.

The following dates are fixed:
(dop) 2015-11-29
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-05-29
standards conflicting with the
document have to be withdrawn
This document supersedes EN 80601-2-58:2009.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 80601-2-58:2014 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:

1)
IEC 60065:2001 NOTE Harmonized as EN 60065:2002 (modified).
IEC 60825-1 NOTE Harmonized as EN 60825-1.
IEC 60950-1 NOTE Harmonized as EN 60950-1.
IEC 61847 NOTE Harmonized as EN 61847.
ISO 15004-2:2007 NOTE Harmonized as EN ISO 15004-2:2007 (not modified).
ISO 15752:2010 NOTE Harmonized as EN ISO 15752:2010 (not modified).

1)
Superseded by EN 60065:2014 (IEC 60065:2014): DOW = 2017-11-17.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu
Publication Year Title EN/HD Year
Annex ZA of EN 60601-1:2006 applies except as follows:
Replacement:
1)
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
1)
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
Addition:
IEC 60601-2-2 -  Medical electrical equipment - EN 60601-2-2 -
Part 2-2: Particular requirements for the
basic safety and essential performance of
high frequency surgical equipment and
high frequency surgical accessories
IEC 60601-2-22 -  Medical electrical equipment - EN 60601-2-22 -
Part 2-22: Particular requirements
for basic safety and essential performance
of surgical, cosmetic, therapeutic and
diagnostic laser equipment
ISO 11607-1 2006 Packaging for terminally sterilized EN ISO 11607-1 2009
medical devices -
Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 11607-2 2006 Packaging for terminally sterilized EN ISO 11607-2 2006
medical devices -
Part-2: Validation requirements for forming,
sealing and assembly processes
ISO 17664 2004 Sterilization of medical devices - EN ISO 17664 2004
Information to be provided by the
manufacturer for the processing of
resterilizable medical devices

1)
Superseded by EN 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2018-12-31.
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 80601-2-58
Edition 2.0 2014-09
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
PRICE CODE
INTERNATIONALE
CODE PRIX U
ICS 11.040.70 ISBN 978-2-8322-1820-4

– 2 – IEC 80601-2-58:2014 © IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents. 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 13
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 * ME SYSTEMS . 21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 22
202 Electromagnetic compatibility – Requirements and tests . 22
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 23
Annex AA (informative) Particular guidance and rationale . 24
Bibliography . 26
Index of defined terms . 27

Figure 201.101 – Test method for gravity fed IRRIGATION . 14
Figure 201.102 – Test method for pressurized IRRIGATION . 15
Figure 201.103 – Test method for ASPIRATION pressure measurement/display accuracy . 16
Figure 201.104 – Test method for ultrasonic velocity of tip accuracy . 18

Table 201.101 – Key of symbols for Figure 201.101 to Figure 201.103 . 16
Table 201.C.101 – ACCOMPANYING DOCUMENTS, instructions for use of LENS REMOVAL
and VITRECTOMY DEVICES or their parts . 23
DEVICES
IEC 80601-2-58:2014 © IEC 2014 – 3 –
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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 80601-2-58 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice, and subcommittee SC 7: Ophthalmic optics and instruments of ISO technical
committee 172: Optics and photonics.
This second edition cancels and replaces the first edition of IEC 80601-2-58 published in 2008.
It is published as a double logo standard.

– 4 – IEC 80601-2-58:2014 © IEC 2014
The text of this standard is based on the following documents:
FDIS Report on voting
62D/1151/FDIS 62D/1161/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 12 P members
out of 12 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 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 publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IEC 80601-2-58:2014 © IEC 2014 – 5 –
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 International Standard
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)
PROCEDURES to maximize surgical outcomes.
and posterior-segment (vitreoretinal) surgical
For this reason both LENS REMOVAL DEVICES and VITRECTOMY DEVICES are covered in this
International Standard.
As all particular standards in the IEC 60601-1 series are based on the general standard
IEC 60601-1, the user of this standard is reminded that RISK MANGEMENT plays an important
role in the use of this particular standard. Compliance with the requirements of this particular
RISK MANAGEMENT FILE to ensure the HAZARDS
standard should be documented in the
associated with the product have been considered fully.

– 6 – IEC 80601-2-58:2014 © IEC 2014
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 applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208
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 standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
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 201.3.208 and 201.3.217) and associated ACCESSORIES that can be
connected to the ME EQUIPMENT and are to be tested together or individually.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2007 applies as modified in Clause 202. All other published collateral
standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
The general standard is IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance

IEC 80601-2-58:2014 © IEC 2014 – 7 –
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
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 particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
”Replacement” means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard 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 particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 26.
Clause 2 of the general standard applies, except as follows:
Replacement:
– 8 – IEC 80601-2-58:2014 © IEC 2014
IEC 60601-1-2:2007 , Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-2-2, 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 60601-2-22, Medical electrical equipment – Part 2-22: Particular requirements for the
basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment
ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements
for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006, Packaging for terminally sterilized medical devices – Part 2: Validation
requirements for forming, sealing and assembly processes
ISO 17664:2004, Sterilization of medical devices – Information to be provided by the
manufacturer for the processing of resterilizable medical devices
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1, apply,
except as follows:
NOTE An index of defined terms is found beginning on page 27.
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
HANDPIECE
PROBE
handheld APPLIED PART, an ACCESSORY of LENS REMOVAL DEVICES or VITRECTOMY DEVICES

Third edition. Although a new, fourth edition of IEC 60601-1-2 was published in 2014, the normative references
to this collateral standard in the present particular standard refer to the third edition, published in 2007.

IEC 80601-2-58:2014 © IEC 2014 – 9 –
201.3.205
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 60825-1:2007, 3.41]
201.3.206
LASER FRAGMENTATION
method by which the lens is broken into small fragments using LASER energy
201.3.207
LENS REMOVAL
removal of unwanted lens tissue
201.3.208
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
PHACOEMULSIFICATION, LIQUEFACTION, or LASER FRAGMENTATION
Note 1 to entry: These devices may 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 201.3.208.
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
– 10 – IEC 80601-2-58:2014 © IEC 2014
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 may also be used for other ocular surgical purposes.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 General
For LENS REMOVAL DEVICES and VITRECTOMY DEVICES no ESSENTIAL PERFORMANCE has been
LENS REMOVAL DEVICES and VITRECTOMY DEVICES have functions
identified in general. If the
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.
Addition:
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.
ME EQUIPMENT includes a LASER function, that function shall meet the requirements of
If the
IEC 60601-2-22.
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 applies.

IEC 80601-2-58:2014 © IEC 2014 – 11 –
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
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;
RISK of injury, ratings of lamp,
e) if applicable, warnings related to lamp replacement (e.g.
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
PHOTORETINITIS and serious permanent
prolonged periods of time due to the potential for
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
is not exceeded as this could cause a HAZARDOUS SITUATION to the PATIENT.
CONTAINER
201.7.9.2.8 Start-up PROCEDURE
Addition:
The instructions for use shall include instructions to perform functional checks of the system
before first use of the day.
201.7.9.2.9 Operating instructions
Addition:
The operating instructions shall additionally include:
PRIMING, changing, and reloading the TUBING
a) if applicable, instructions regarding loading,
SET(s), and the TUBING SET(s) change interval to maintain the specified performance;

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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 17664:2004. This information shall be provided to the RESPONSIBLE ORGANIZATION or the
OPERATOR.
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.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard 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 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:
IEC 80601-2-58:2014 © IEC 2014 – 13 –
The packaging for terminally sterilized ACCESSORIES for LENS REMOVAL DEVICES and
VITRECTOMY DEVICES shall comply with the requirements of ISO 11607-1:2006. Validation
requirements for forming, sealing, and assembly processes for this packaging shall be
consistent with ISO 11607-2:2006.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 Additional accuracy of controls and instruments requirements
NOTE Additional requirements for accuracy of controls and instruments are detailed in subclauses 201.12.1.101.1
to 201.12.1.101.5 and 201.12.1.101.7 to 201.12.1.101.9.
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.
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.

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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 step 6 and 7 for test pressure setting in 20 mmHg (2,7 kPa) increments until
the maximum pressure setting is reached.
9) Repeat the readings used in steps 6, 7 and 8 as the pressure is decreased and wait for
5 s and record the pressure meter reading at each point.
NOTE This may involve reconnection of the IRRIGATION tubing for the decreasing measurements.
10) Confirm that all the readings are within the stated range.

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For key, see Table 201.101
Figure 201.102 – Test method for pressurized IRRIGATION
201.12.1.101.2 Accuracy of ASPIRATION pressure
ASPIRATION pressure output shall not deviate from the indicated setting on the LENS REMOVAL
DEVICES and VITRECTOMY DEVICES by more than ± 20 % or ± 30 mmHg (± 4 kPa) whichever is
greater (see 201.12.4.101.2 for hazardous output limit).
Compliance is checked using the following test method:
Test method: ASPIRATION pressure measurement/display accuracy
1) Install a new TUBING SET to device under test. PRIME the TUBING SET.
2) Zero the pressure meter (PM) reading. Connect the pressure meter to the end of the
ASPIRATION TUBING and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.103.
3) In the ASPIRATION mode adjust the vacuum preset to 50 mmHg (6,7 kPa).
4) For flow-based system, set flow rate at least to 10 ml/min.
5) Depress (foot) control to activate aspiration vacuum.
6) Record the pressure meter reading and the vacuum value displayed on the instrument
after 5 s.
7) Repeat step 5 and 6 for the test pressure values at 100 mmHg (13,3 kPa) increments
steps to the maximum designed vacuum.
8) Repeat the tests of step 7 in the reverse order of pressure values.
9) Confirm that all the readings are within the stated range.

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For key, see Table 201.101
Figure 201.103 – Test method for ASPIRATION pressure measurement/display accuracy
Table 201.101 – Key of symbols for Figure 201.101 to Figure 201.103
1 Equipment under test
2 Pressure meter
PATIENT eye level
4 IRRIGATION tube
5 Reservoir hanger
Gravity feed reservoir
7 Spike
8 Reservoir
Pressurized IRRIGATION TUBING SET

10 ASPIRATION tube
201.12.1.101.3 Accuracy of DIATHERMY power
If a DIATHERMY function is provided, the total output power and the actual power as a function
of the load resistance shall comply with the requirements of IEC 60601-2-2 (see
201.12.4.101.3 for hazardous output limit).
Compliance is checked using the following test method: Test according to the requirements of
IEC 60601-2-2 and verify the readings are within ranges identified in subclause
201.12.4.101.3 for the DIATHERMY power
...