IEC 80601-2-58:2014 ED2

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 ED2

Publication date:   Sep 4, 2014

General information

99.60 Withdrawal effective   Mar 6, 2024

IEC

TC 62/SC 62D

International Standard

11.040.70   Ophthalmic equipment

Buying

Revised

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
IEC 80601-2-58:2008 ED1

NOW

WITHDRAWN
IEC 80601-2-58:2014 ED2
99.60 Withdrawal effective
Mar 6, 2024

CORRIGENDA / AMENDMENTS

WITHDRAWN
IEC 80601-2-58:2014/AMD1:2016 ED2

REVISED BY

PUBLISHED
IEC 80601-2-58:2024 ED3