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IEC 80601-2-58 Ed. 2.0 Edition 09/2014
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
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Abstract

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.

Status

Standard - Superseded

Origin

Technical Committee :
62D : Electromedical equipment

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Evolutions
IEC 80601-2-58 Ed.3.0

Relations to older standards
IEC 80601-2-58 Ed. 1.0

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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