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AAMI EC12 - DISPOSABLE ECG ELECTRODES - FDA RECOGNIZED Organization: AAMI
Date: 2000-01-01
Description: 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 (see 3.4).
AAMI DF80 - MEDICAL ELECTRICAL EQUIPMENT—PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS (INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS) Organization: AAMI
Date: 2003-01-01
Description: 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.
AAMI EC11 - DIAGNOSTIC ELECTROCARDIOGRAPHIC DEVICES Organization: AAMI
Date: 1991-01-01
Description: (See also the AAMI standard for disposable ECG electrodes, applicable document 2.2.2.) 2)It is recognized that the quality of telephone line or other means of transmission cannot be controlled by the electrocardiograph manufacturer.
IEC 60601-2-4 - MEDICAL ELECTRICAL EQUIPMENT – PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS - EDITION 3.0 Organization: IEC
Date: 2010-12-01
Description: 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.
CENELEC - EN 60601-2-4 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS Organization: CENELEC
Date: 2011-08-01
Description: 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.
CEI EN 60601-2-4 - MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS Organization: CEI
Date: 2012-05-01
Description: 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.
AAMI 60601-2-4 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS Organization: AAMI
Date: 2010-01-01
Description: 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]3). 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.
CSA C22.2 NO 60601-2-4 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS - THIRD EDITION Organization: CSA
Date: 2012-01-01
Description: 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.

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