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

IEC 80601-2-58:2008 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment.

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

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• Status: Withdrawn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: 05-Feb-2009
• Withdrawal Date: 31-Jan-2012
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 29-May-2018
• Completion Date: 29-May-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: 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)

Relations

• Replaced By: 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
• Effective Date: 28-Jan-2023
• Amended By: EN 80601-2-58:2009/A11:2011 - 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

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2009
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.

- 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).
__________
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.
- 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.
__________
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

– 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
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) i
...