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/A1:2016)

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 (IEC 80601-2-58:2014/A1:2016)

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 80601-2-58:2014/A1:2016)

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 - Dopolnilo A1 (IEC 80601-2-58:2014/A1:2016)

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
08-Sep-2019
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Sep-2019
Due Date
07-Nov-2019
Completion Date
09-Sep-2019

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SLOVENSKI STANDARD
SIST EN 80601-2-58:2015/A1:2019
01-november-2019
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 - Dopolnilo A1 (IEC 80601-2-58:2014/A1:2016)

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/A1:2016)

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 80601-2-58:2014/A1:2016)

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 80601-2-58:2014/A1:2016)
Ta slovenski standard je istoveten z: EN 80601-2-58:2015/A1:2019
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN 80601-2-58:2015/A1:2019 en

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

---------------------- Page: 1 ----------------------
SIST EN 80601-2-58:2015/A1:2019
---------------------- Page: 2 ----------------------
SIST EN 80601-2-58:2015/A1:2019
EUROPEAN STANDARD EN 80601-2-58:2015/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2019
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 80601-2-58:2014/A1:2016)

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/A1:2016) der Augenchirurgie
(IEC 80601-2-58:2014/A1:2016)

This amendment A1 modifies the European Standard EN 80601-2-58:2015; it was approved by CENELEC on 2019-08-07. CENELEC

members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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,

Turkey 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

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 80601-2-58:2015/A1:2019 E
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SIST EN 80601-2-58:2015/A1:2019
EN 80601-2-58:2015/A1:2019 (E)
European foreword

The text of document 62D/1364/FDIS, future IEC 80601-2-58:2014/A1, prepared by SC 62D

"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to

the IEC-CENELEC parallel vote and approved by CENELEC as EN 80601-2-58:2015/A1:2019.

The following dates are fixed:
(dop) 2020-02-23
• 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 standards conflicting with (dow) 2022-08-23
the document have to be withdrawn

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 mandate given to CENELEC by the European Commission

and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 80601-2-

58:2015.
Endorsement notice

The text of the International Standard IEC 80601-2-58:2014/A1:2016 was approved by CENELEC as

a European Standard without any modification.
Replace:
IEC 60825-1 NOTE Harmonized as EN 60825-1.
IEC 61847 NOTE Harmonized as EN 61847.
IEC 60950-1 NOTE Harmonized as EN 60950-1.
IEC 60065 NOTE Harmonized as EN 60065.
---------------------- Page: 4 ----------------------
SIST EN 80601-2-58:2015/A1:2019
EN 80601-2-58:2015/A1:2019 (E)
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 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

In Annex ZA of EN 80601-2-58:2015, replace the existing references to the following

publications as follows:
IEC 60601-1-2 - Medical electrical equipment -- Part 1-2: EN 60601-1-2 -
General requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic disturbances -
Requirements and tests
+ 1 2014 + A1 2014
+ 1 2014 + A1 2014
Addition:
CISPR 11 - Industrial, scientific and medical equipment EN 55011 -
- Radio-frequency disturbance
characteristics - Limits and methods of
measurement
ISO 11607-2014 Packaging for terminally sterilized medical EN ISO 11607-2014
1:2006/Amd1 devices - Part 1: Requirements for 1:2009/A1
materials, sterile barrier systems and
packaging systems
ISO 11607-2014 Packaging for terminally sterilized medical EN ISO 11607-2014
2:2006/Amd1 devices - Part 2: Validation requirements 2:2006/A1
for forming, sealing and assembly
processes)
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SIST EN 80601-2-58:2015/A1:2019
---------------------- Page: 6 ----------------------
SIST EN 80601-2-58:2015/A1:2019
IEC 80601-2-58
Edition 2.0 2016-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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 978-2-8322-3568-3

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.

---------------------- Page: 7 ----------------------
SIST EN 80601-2-58:2015/A1:2019
– 2 – IEC 80601-2-58:2014/AMD1:2016
© IEC 2016
FOREWORD

This amendment 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.

The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1364/FDIS 62D/1370/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 11

P members out of 11 having cast a vote.

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.
___________
INTRODUCTION TO THE AMENDMENT

This amendment modifies the content of the second edition of IEC 80601-2-58 published in

2014. This Amendment constitutes a technical revision.

This amendment includes the following significant technical changes with respect to the

second edition:

a) integration of updated definition of ESSENTIAL PERFORMANCE and updating the ESSENTIAL

PERFORMANCE analysis;

b) undating collateral and general standard references to align with amendments to the

general standard and other collateral standards;
c) addition of symbols to standard;
d) update of EMC requirements.
___________
201.1.3 Collateral standards
Replace the existing title of this subclause by the following new title:
201.1.3 * Collateral standards
Replace the existing text of the second paragraph by the following:
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-10,
IEC 60601-1-11, and IEC 60601-1-12 do not apply.
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SIST EN 80601-2-58:2015/A1:2019
IEC 80601-2-58:2014/AMD1:2016 – 3 –
© IEC 2016
201.1.4 Particular standards

Add, in the fourth paragraph of the subclause, "IEC" before the existing references to "60601-

1-2" and "60601-1-3".

Add, in the second sentence of the eight paragraph of the subclause, a comma immediately

after “However”.
201.2 Normative references
Delete the second footnote of the standard.
Replace the existing reference to IEC 60601-1-2, by the following new reference:

IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral standard: Electromagnetic disturbances –

Requirements and tests
Add, before the existing reference to ISO 11607-1, the following new reference:

CISPR 11, Industrial, scientific and medical equipment – Radio-frequency disturbance

characteristics – Limits and methods of measurement
Add, in the following references, the reference to Amendment 1 "AMD1:2014":

ISO 11607-1:2006/AMD1:2014, Packaging for terminally sterilized medical devices – Part 1:

Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2:2006/AMD1:2014, Packaging for terminally sterilized medical devices – Part 2:

Validation requirements for forming, sealing and assembly processes
201.3.205

Replace the existing source by the following new source and add the end of page footnote as

follows:
[SOURCE: IEC 60825-1:2014, 3.44 [1] ]
Numbers in square brackets refer to the Bibliography.
201.3.208
LENS REMOVAL DEVICE

Replace the existing definition by the following, without modifying the existing Note to entry:

ME EQUIPMENT OR ME SYSTEM designed to remove lens material which incorporates an
IRRIGATION and ASPIRATION function, and a mechanism for LENS REMOVAL such as
PHACOFRAGMENTATION, LIQUEFACTION, OR LASER FRAGMENTATION
201.7 ME EQUIPMENT identification, marking and documents
Add, after the instruction for subclause 201.7, the following new subcause:
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SIST EN 80601-2-58:2015/A1:2019
– 4 – IEC 80601-2-58:2014/AMD1:2016
© IEC 2016
201.7.6.101 * Additional symbols
Addition:
Symbols for LENS REMOVAL and VITRECTOMY.

If symbols for LENS REMOVAL and VITRECTOMY devices that have functions such as DIATHERMY,

FRAGMENTATION, LIQUEFACTION FRAGMENTATION, VITRECTOMY, and illumination are used, they

shall be based on the recommended symbols of Annex D and be on the device or near the

connection point of the function.
201.7.9.2.12 Cleaning, disinfection, and sterilization

Add, at the end of the last sentence of the subclause, the following reference: [2].

201.11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS

Replace, in the existing text, the references to ISO 11607-1:2006 and ISO 11607-2:2006 by

"ISO 11607-1:2006/AMD1:2014" and "ISO 11607-2:2006/AMD1:2014" respectively.
201.12.1.101.7 Accuracy of ultrasonic velocity of TIP
Replace the first paragraph by the following:

If the ultrasonic velocity is not specified in the instruction for use, measurement of the

ultrasonic velocity of the tip is not required. If an ultrasonic fragmentation function is provided,

the ultrasonic velocity of the TIP shall not deviate by more than ± 20 % from the NOMINAL

value(s) stated in the instructions for use for each listed configuration. In the case that the

ultrasonic velocity is not specified in the instruction for use, measurement of the tip stroke

exiting the tip or equivalent shall be made to assure the ultrasonic fragmentation function

meets the hazardous output limit (see 201.12.4.101.7 for hazardous output limit).

Add, after the end of item 1) in the list, the following reference to the bibliography "[3]".

Replace the existing text in test method step 2) b) by the following:

b) verify that the values displayed by the oscilloscope are within ± 20 % of the NOMINAL

value(s) for the ultrasonic frequency(ies);
201.12.1.101.8 Accuracy of velocity of fluid entering eye for LIQUEFACTION
Replace the first paragraph by the following:
If a LIQUEFA
...

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