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ISO/IEC 80601-2-58 2nd Edition, September 15, 2014 Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
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Availability date: 07/13/2021
Description / Abstract:
This International Standard applies to the BASIC SAFETY and
ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY
DEVICES for ophthalmic surgery (as defined in 201.3.208 and
201.3.217) and associated ACCESSORIES that can be connected to this
MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME
EQUIPMENT.
If a clause or subclause is specifically intended to be
applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title
and content of that clause or subclause will say so. If that is not
the case, the clause or subclause applies both to ME EQUIPMENT and
to ME SYSTEMS, as relevant.
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.
NOTE See also 4.2 of the general standard.