BS EN 60601-2-4:2011+A1:2019 Medical electrical equipment - Particular requirements for the basic safety and essential performance of cardiac defibrillators
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 cardiac defibrillators , 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.
H azards 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.
This particular standard does not apply to implantable defibrillators , remote control