ANSI/AAMI DF80:2003 pdf download.Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators).
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS as defined in 2.1.101, hereinafter referred to as EQUIPMENT.
This Particular Standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS , or separate stand alone CARDIAC MONITORS (which are standardized by IEC 60601-2-27). 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 address considerations in waveform selection.
This specification defines minimum pad electrode performance. It does not ensure compatibility of a particular pad electrode-defibrillator combination nor does it ensure an acceptable level of performance While it provides reasonable assurance of safe performance, it does not ensure compatibility of a particular pad electrode-defibrillator combination. As such, the consumer should request compatibility test information from the manufacturer(s).
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of CARDIAC DEFIBRILLATORS as defined in 2.1.101.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment—Part 1: General requirements for safety as amended by its amendment 1 (1991) and amendment 2 (1995).
For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or as the “General Requirement(s).”
The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:
“Replacement” means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard.
“Addition” means that the text of this Particular Standard is additional to the requirements of the General Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
The term “this Standard” is used to make reference to the General Standard and this Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the section,clause, or subclause of the General Standard, although possibly not relevant, applies without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
1.5 Collateral Standards
Addition:
The following Collateral Standards apply:
IEC 60601-1-1:2000, Medical electrical equipment—Part 1-1: General requirements for safety—Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001, Medical electrical equipment—Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment—Part 1: General requirements for safety—4.Collateral Standard: Programmable electrical medical systems.ANSI/AAMI DF80 pdf download.