prEN IEC 80601-2-58:2022

SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-58:2022
01-november-2022
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
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
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
Ta slovenski standard je istoveten z: prEN IEC 80601-2-58:2022
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN IEC 80601-2-58:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 80601-2-58:2022

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oSIST prEN IEC 80601-2-58:2022
62D/1969/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-58 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-09-09 2022-12-02
SUPERSEDES DOCUMENTS:
62D/1914/CD, 62D/1936A/CC

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.

TITLE:
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 STABILITY DATE: 2028

NOTE FROM TC/SC OFFICERS:

Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

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oSIST prEN IEC 80601-2-58:2022
62D/1969/CDV – 2 – IEC 80601-2-58:2022
 © IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 6
5 201.1 Scope, object and related standards . 8
6 201.2 Normative references . 10
7 201.3 Terms and definitions . 11
8 201.4 General requirements . 13
9 201.5 General requirements for testing of ME EQUIPMENT . 13
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
11 201.7 ME EQUIPMENT identification, marking and documents . 13
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 15
15 201.11 Protection against e
...