IEC 80601-2-58 applies to the essential safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and related accessories that can be connected to this medical electrical equipment, hereinafter referred to as ME equipment.
Hazards inherent in the intended physiological function of ME equipment or ME systems covered by this standard are not covered by the specific requirements in this standard, except in 7.2.13 and 8.4.1 of the general standard.
This second edition includes the comments made during the approval of the first edition as the European Medical Device Directive and amendments made to take into account comments from other National Committees during the finalization of the first edition of this standard.
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