BS EN 80601-2-58:2015+A1:2019 - Page 2

Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | Status: Current, Superseded

201.1 Scope, object and related standards Clause 1 of the general standard 1 applies, except as follows:

201.1.1 * Scope

Replacement: 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.