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EVS-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

General information
Valid from 02.09.2019
Base Documents
IEC 80601-2-58:2014/A1:2016; EN 80601-2-58:2015/A1:2019
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.09.2019
Amendment
02.07.2015
Main
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.
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