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.
This particular standard does not apply to implantable defibrillators, remote control
DEFIBRILLATORS, external transcutaneous pacemakers, or separate stand-alone cardiac
monitors (which are standardized by IEC 60601-2-27 [2]2). 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.
Defibrillation waveform technology is evolving rapidly. Published studies indicate that the
effectiveness of waveforms varies. The choice of a particular waveform including waveshape,
delivered energy, efficacy, and safety has been specifically excluded from the scope of this
standard.
However, due to the critical importance of the therapeutic waveform, comments have been
added to the rationale which addresses considerations in waveform selection.
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for cardiac defibrillators as defined in 201.3.202.