ECG Electrode Standards

This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring. Inclusions Included within the scope of this standard is any disposable ECG electrode system...

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...

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...

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...

This standard establishes minimum safety and performance requirements for electrocardiographic (ECG) systems with direct writing devices which are intended for use, under the operating conditions specified in this standard, in the analysis of rhythm and of detailed morphology of complex...