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

IEC 80601-2-58:2014 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, hereafter referred to as ME equipment. 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. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this 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

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

• Status: Published
• Publication Date: 28-May-2015
• Withdrawal Date: 28-May-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 29-May-2015
• Completion Date: 29-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to 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 80601-2-58:2015 - 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

Relations

• Replaces: 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
• Replaces: 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
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 80601-2-58:2024 - 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: 05-Oct-2021
• Amended By: EN 80601-2-58:2015/A1:2019 - 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: 16-Jun-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 80601-2-58:2009
SIST EN 80601-2-58:2009/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]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
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 subj
...