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

IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 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 document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.

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

IEC 80601-2-58:2024 est disponible sous forme de IEC 80601-2-58:2024 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 80601-2-58:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des DISPOSITIFS DE RETRAIT DU CRISTALLIN et des DISPOSITIFS DE VITRECTOMIE pour la chirurgie ophtalmique (comme cela est défini en 201.3.209 et 201.3.217) et des ACCESSOIRES liés qui peuvent être raccordés à ces APPAREILS ELECTROMEDICAUX, désignés ci-après comme APPAREILS EM. Lorsqu’un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si ce n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l’exception du 7.2.13 de l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD2:2020 et du 8.4.1 de l’IEC 60601-1:2005. L'IEC 80601-2-58:2024 le et remplace la deuxième édition parue en 2014 et son Amendement 1:2016. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) alignement de la présente norme particulière sur la base des amendements de l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et de l'IEC 60601-1:2005/AMD2:2020; b) mise à jour des références à l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 et aux normes particulières et collatérales pour les aligner sur les amendements de l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 et des autres normes collatérales; c) mise à jour des références normatives; d) ajout d’une nouvelle exigence relative aux corps solides qui proviennent des PARTIES APPLIQUEES dans le 201.9.5.101; e) ajout de la méthode de la lumière rasante dans le 201.12.1.101.7; f) clarification des conditions d’essai pour les exigences de CEM dans le 202.7.1.2; g) mise à jour des références du Tableau D.4 pour inclure les références IEC spécifiques aux symboles et supprimer le "201.7.6.101" existant de l’"Annexe AA"; h) inclusion d’une nouvelle annexe pour couvrir les exigences générales pertinentes en matière de sécurité et de performances du règlement européen (UE) 2017/745 (Annexe BB). i) suppression de toutes les références à la méthode de RETRAIT DU CRISTALLIN au moyen de la FRAGMENTATION PAR LIQUEFACTION.

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 80601-2-58:2024)

General Information

• Status: Published
• Publication Date: 19-Sep-2024
• 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: 20-Sep-2024
• Due Date: 29-Dec-2023
• Completion Date: 20-Sep-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• 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/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST 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 (IEC 80601-2-58:2024)

Relations

• Replaces: 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: 05-Oct-2021
• Replaces: 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: 05-Oct-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2024
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 80601-2-58:2024)
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 (IEC 80601-2-58:2024)
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 80601-2-58:2024
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 (IEC 80601-2-58:2024
Ta slovenski standard je istoveten z: EN IEC 80601-2-58:2024
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 IEC 80601-2-58

NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
ICS 11.040.70 Supersedes EN 80601-2-58:2015; EN 80601-2-
58:2015/A1:2019
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 80601-2-58:2024)
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 80601-2-58:2024) der Augenchirurgie
(IEC 80601-2-58:2024)
This European Standard was approved by CENELEC on 2024-07-31. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-58:2024 E

European foreword
The text of document 62D/2096/FDIS, future edition 3 of IEC 80601-2-58, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-01
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-07-31
document have to be withdrawn
This document supersedes EN 80601-2-58:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CENELEC by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80601-2-58:2024 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 standard indicated:
IEC 60601-1-3:2008 NOTE Approved as EN 60601-1-3:2008 (not modified) +A11:2016
IEC 60601-1-3:2008/A1:2013 NOTE Approved as EN 60601-1-3:2008/A1:2013 (not modified)
IEC 60601-1-3:2008/A2:2021 NOTE Approved as EN 60601-1-3:2008/A2:2021 (not modified)
IEC 60601-1-9:2007 NOTE Approved as EN 60601-1-9:2008 (not modified)
IEC 60601-1-9:2007/A1:2013 NOTE Approved as EN 60601-1-9:2008/A1:2013 (not modified)
IEC 60601-1-9:2007/A2:2020 NOTE Approved as EN 60601-1-9:2008/A2:2020 (not modified)
IEC 60601-1-10:2007 NOTE Approved as EN 60601-1-10:2008 (not modified)
IEC 60601-1-10:2007/A1:2013 NOTE Approved as EN 60601-1-10:2008/A1:2015 (not modified)
IEC 60601-1-10:2007/A2:2020 NOTE Approved as EN 60601-1-10:2008/A2:2021 (not modified)
IEC 60601-1-11:2015 NOTE Approved as EN 60601-1-11:2015 (not modified)
IEC 60601-1-11:2015/A1:2020 NOTE Approved as EN 60601-1-11:2015/A1:2021 (not modified)
IEC 60601-1-12:2014 NOTE Approved as EN 60601-1-12:2015 (not modified)
IEC 60601-1-12:2014/A1:2020 NOTE Approved as EN 60601-1-12:2015/A1:2020 (not modified)
ISO 15004-2:2007 NOTE Approved as EN ISO 15004-2:2007 (not modified)
IEC 60825-1:2014 NOTE Approved as EN 60825-1:2014 (not modified) +A11:2021
IEC 61847:1998 NOTE Approved as EN 61847:1998 (not modified)
IEC 62368-1:2018 NOTE Approved as EN IEC 62368-1:2020 (not modified) +A11:2020
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1  Where 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.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Add:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60601-2-2 2017 Medical electrical equipment - Part 2-2: EN IEC 60601- 2018
Particular requirements for the basic safety 2-2
and essential performance of high frequency
surgical equipment and high frequency
surgical accessories
+ AMD1 2023 + A1 2024
IEC 60601-2-22 2019 Medical electrical equipment - Part 2-22: EN IEC 60601- 2020
Particular requirements for basic safety and 2-22
essential performance of surgical, cosmetic,
therapeutic and diagnostic laser equipment

As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Publication Year Title EN/HD Year
CISPR 11 (mod) 2015 Industrial, scientific and medical equipment - EN 55011 2016
Radio-frequency disturbance characteristics
- Limits and methods of measurement
+ A1 2016 + A1 2017
- - + A11 2020
+ A2 2019 + A2 2021
ISO 11607-1 2019 Packaging for terminally sterilized medical EN ISO 11607-1 2020
devices - Part 1: Requirements for materials,
sterile barrier systems and packaging
systems
- - + A11 2022
ISO 11607-2 2019 Packaging for terminally sterilized medical EN ISO 11607-2 2020
devices - Part 2: Validation requirements for
forming, sealing and assembly processes
- - + A11 2022
ISO 17664 2017 Processing of health care products - EN ISO 17664 2017
Information to be provided by the medical
device manufacturer for the processing of
medical devices
EN ISO 17664:2017 has been withdrawn and replaced with EN ISO 17664-1:2021.
IEC 80601-2-58
Edition 3.0 2024-03
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
INTERNATIONALE
ICS 11.040.70 ISBN 978-2-8322-8132-1

– 2 – IEC 80601-2-58:2024 © IEC 2024
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements. 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS. 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 * ME SYSTEMS . 24
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
202 Electromagnetic disturbances – Requirements and tests . 25
Annexes . 26
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 26
Annex D (informative) Symbols on marking (See Clause 7) . 27
Annex AA (informative) Particular guidance and rationale . 28
Annex BB (informative) Reference to the general safety and performance
requirements . 34
Bibliography . 36
Index of defined terms . 38

Figure 201.101 – Test method for gravity fed IRRIGATION . 16
Figure 201.102 – Test method for pressurized IRRIGATION .
...