SIST EN 80601-2-58:2015
(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 - Proposed Horizontal Standards
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
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.
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
L'IEC 80601-2-58:2014 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 des accessoires liés qui peuvent être raccordés à ces appareils électromédicaux, désignés ci-après comme appareils EM. Les dangers inhérents à la fonction physiologique prévue de l'appareil EM ou des systèmes EM dans le cadre du domaine d'application de la présente norme ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception de 7.2.13 et 8.4.1 de la norme générale. Cette seconde édition contient des changements permettant de prendre en compte les commentaires soumis durant l'approbation de la première édition en tant que Directive Médicale Européenne, ainsi que des commentaires d'autre Comités Nationaux soumis lors de la finalisation de la première édition de cette norme.
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 - Predlagani horizontalni standardi
Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI NAPRAV
ZA ODSTRANJEVANJE LEČ in NAPRAV ZA VITREKTOMIJO za očesno operacijo (kot je opredeljeno v poglavjih 201.3.208
in 201.3.217) ter povezanih DODATKOV, ki jih je mogoče priključiti na to MEDICINSKO ELEKTRIČNO OPREMO, v nadaljevanju: ME OPREMA. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glej tudi točko 4.2 splošnega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 80601-2-58:2015
01-september-2015
1DGRPHãþD
SIST EN 80601-2-58:2009
SIST EN 80601-2-58:2009/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLQDSUDY]DRGVWUDQMHYDQMHOHþLQQDSUDY]DYLWUHNWRPLMRSULRþHVQL
NLUXUJLML3UHGODJDQLKRUL]RQWDOQLVWDQGDUGL
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
SIST EN 80601-2-58:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 80601-2-58:2015
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SIST EN 80601-2-58:2015
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
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SIST EN 80601-2-58:2015
EN 80601-2-58:2015
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.
2
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SIST EN 80601-2-58:2015
EN 80601-2-58:2015
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.
3
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EN 80601-2-58:2015
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.
4
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SIST EN 80601-2-58:2015
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
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
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SIST EN 80601-2-58:2015
– 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
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SIST EN 80601-2-58:2015
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.
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SIST EN 80601-2-58:2015
– 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.
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SIST EN 80601-2-58:2015
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.
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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
201.1 Scope, object and related standards
1
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:
1
The general standard is IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
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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:
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2
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
2
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 t
...
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