AS 60601.2.4:2018 PDF

AS 60601.2.4:2018 PDF

The objective of this Standard is to establish particular basic safety and essential performance requirements for cardiac defibrillators. This Standard does not apply to implantable defibrillators, remote control defibrillators, external transcutaneous pacemakers, or separate stand-alone cardiac monitors (which are standardized by AS/NZS IEC 60601.2.27:2016). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this Standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion.

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.

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.