SIST EN 80601-2-58:2009

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2008)

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.

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 (IEC 80601-2-58:2008)

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 (CEI 80601-2-58:2008)

La CEI 80601-2-58:2008 s'applique à la sécurité de base et aux performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique et les accessoires liés qui peuvent être raccordés à ces appareils électromédicaux.

Medicinska električna oprema - 2-58. del: Posebne zahteve za osnovno varnost in bistvene lastnosti naprav za odstranjevanje leč in naprav za vitrektomijo pri očesni kirurgiji (IEC 80601-2-58:2008)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI NAPRAV ZA ODSTRANJEVANJE LEČ in NAPRAV ZA VITREKTOMIJO pri očesni kirurgiji (kot je določeno v 201.3.208 in 201.3.217) in povezane DODATKE, ki so lahko povezani s to MEDICINSKO ELEKTRIČNO OPREMO, v nadaljevanju ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.

General Information

• Status: Withdrawn
• Publication Date: 08-Mar-2009
• Withdrawal Date: 19-Aug-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 09-Aug-2018
• Due Date: 01-Sep-2018
• Completion Date: 20-Aug-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 80601-2-58:2009 - 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

Relations

• Amended By: SIST EN 80601-2-58:2009/A11:2012 - 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
• Effective Date: 29-Jan-2023
• Amended By: SIST EN 80601-2-58:2009/A11:2012 - 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
• Effective Date: 07-Jun-2022
• Replaced By: SIST EN 80601-2-58:2015 - 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
• Effective Date: 28-Jan-2023
• Amended By: SIST EN 80601-2-58:2009/A11:2012 - 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
• Effective Date: 11-Oct-2011
• Replaced By: SIST EN 80601-2-58:2015 - 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
• Effective Date: 01-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80601-2-58:2009
01-april-2009
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLQDSUDY]DRGVWUDQMHYDQMHOHþLQQDSUDY]DYLWUHNWRPLMRSULRþHVQL
NLUXUJLML,(&
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and
essential performance of lens removal devices and vitrectomy devices for ophthalmic
surgery (IEC 80601-2-58:2008)
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 (IEC 80601-2-58:2008)
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 (CEI 80601-2-58:2008)
Ta slovenski standard je istoveten z: EN 80601-2-58:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN 80601-2-58:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN 80601-2-58

NORME EUROPÉENNE
February 2009
EUROPÄISCHE NORM

ICS 11.040.70


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 80601-2-58:2008)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-58: Exigences particulières Teil 2-58: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des dispositifs de retrait du cristallin für Geräte zur Linsenentfernung
et des dispositifs de vitrectomie und Geräte zur Glaskörperentfernung
pour la chirurgie ophtalmique in der Augenchirurgie
(CEI 80601-2-58:2008) (IEC 80601-2-58:2008)




This European Standard was approved by CENELEC on 2009-02-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: avenue Marnix 17, B - 1000 Brussels


© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 80601-2-58:2009 E

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EN 80601-2-58:2009 - 2 -
Foreword
The text of document 62D/701/FDIS, future edition 1 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 was approved by CENELEC as EN 80601-2-58 on 2009-02-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2009-11-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2012-02-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
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.

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- 3 - EN 80601-2-58:2009
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 80601-2-58:2008 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:
IEC 60065 NOTE  Harmonized as EN 60065:2002 (modified).
IEC 60825-1 NOTE  Harmonized as EN 60825-1:2007 (not modified).
IEC 60950-1 NOTE  Harmonized as EN 60950-1:2006 (modified).
ISO 15004-2 NOTE  Harmonized as EN ISO 15004-2:2007 (not modified).
__________

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EN 80601-2-58:2009 - 4 -
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

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

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests


IEC 60601-2-2 200X Medical electrical equipment - EN 60601-2-2 200X
Part 2-2: Particular requirements for basic
safety and essential performance of high
frequency surgical equipment and high
frequency surgical accessories


1)
IEC 60601-2-22 - Medical electrical equipment - - -
Part 2-22: Particular requirements for basic
safety and essential performance of surgical,
cosmetic, therapeutic and diagnostic laser
equipment


IEC 61847 1998 Ultrasonics - Surgical systems - EN 61847 1998
Measurement and declaration of the basic
output characteristics


ISO 11607-1 2006 Packaging for terminally sterilized medical EN ISO 11607-1 2006
devices -
Part 1: Requirements for materials, sterile
barrier systems and packaging systems


ISO 11607-2 2006 Packaging for terminally sterilized medical EN ISO 11607-2 2006
devices -
Part 2: Validation requirements for forming,
sealing and assembly processes


ISO 15752 2000 Ophthalmic instruments - Endoilluminators - - -
Fundamental requirements and test methods
for optical radiation safety


ISO 17664 2004 Sterilization of medical devices - Information EN ISO 17664 2004
to be provided by the manufacturer for the
processing of resterilizable medical devices



1)
Undated reference.

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- 5 - EN 80601-2-58:2009
Annex ZZ
(informative)

Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
__________

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IEC 80601-2-58
Edition 1.0 2008-10
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
U
CODE PRIX
ICS 11.040.70 ISBN 2-8318-1013-4

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– 2 – 80601-2-58 © IEC:2008
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 .20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .20
201.15 Construction of ME EQUIPMENT .20
201.16 ME SYSTEMS.20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.20
202 Electromagnetic compatibility – Requirements and tests .20
Annexes .22
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.22
Annex AA (informative) Particular guidance and rationale.23
Bibliography.25
Index of defined terms .26

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

Table 201.101 – Legends 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 its parts .22
DEVICES

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80601-2-58 © IEC:2008 – 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, 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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice, and ISO subcommittee SC 7: Ophthalmic optics and instruments of ISO technical
committee 172: Optics and photonics.
It is published as a double logo standard.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/701/FDIS 62D/723/RVD

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved by
14 P-members out of 15 having cast a vote.

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– 4 – 80601-2-58 © IEC:2008
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.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
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 particular standard will remain
unchanged until the maintenance result 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

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80601-2-58 © IEC:2008 – 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)
and posterior-segment (vitreoretinal) surgical PROCEDURES to maximize surgical outcomes.
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 60601-1:2005, 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 standard should be documented in the RISK MANAGEMENT FILE to ensure the HAZARDS
associated with the product have been considered fully.

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– 6 – 80601-2-58 © IEC:2008
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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
This International Standard applies to the
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 IEC 60601-1 and Clause 201.2 of this particular standard.
IEC 60601-1-2 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:
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

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80601-2-58 © IEC:2008 – 7 –
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard 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 x 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 or figures 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 or figures 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 25.
Clause 2 of the general standard applies, except as follows:
Addition:
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

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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
2)
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
IEC 61847:1998, Ultrasonics – Surgical systems – Measurement and declaration of the basic
output characteristics
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 15752:2000, Ophthalmic instruments – Endoilluminators – Fundamental requirements
and test methods for optical radiation safety
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 60601-1:2005,
apply, except as follows:
NOTE An index of defined terms is found beginning on page 26.
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 used for example to
coagulate blood or bind tissues together
NOTE 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
han
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