AAMI EC12 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
DISPOSABLE ECG ELECTRODES
10-04-2021
01-01-2010
Committee representation
Foreword
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Definitions and abbreviations
4 Requirements
4.1 Labeling requirements
4.2 Performance requirements
4.2.1 Packaging and shelf life
4.2.2 Electrical performance
4.3 Safety requirements
4.3.1 Biological response
4.3.2 Pre-attached leadwire safety
4.4 Adhesive performance (duration of use)
5 Tests
5.1 Labeling
5.2 Performance
5.2.1 Packaging and shelf life
5.2.2 Tests for electrical performance
5.3 Safety
5.3.1 Biological response evaluation
5.3.2 Pre-attached leadwire safety
5.4 Adhesive performance (duration of use)
Annexes
A - Rationale for the development and provisions
of this standard
B - Cited references
Covers minimum labeling, safety, and performance requirements for disposable electrodes for use in diagnostic electrocardiography (ECG) or ECG monitoring.
| Committee |
WG 06
|
| DocumentType |
Standard
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| AAMI EC71 : 2001 : R2013 | STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| AAMI DF80 : 2003 : R2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| ISO 11073-91064:2009 | Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography |
| BS EN 1064:2005 | Health informatics. Standard communication protocol. Computer-assisted electrocardiography |
| ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| AAMI EC13 : 2002 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
| AAMI DF80:2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
| AAMI EC71 : 2001 : R2007 | STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| I.S. EN 60601-2-4:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| I.S. EN 1064:2005 | HEALTH INFORMATICS - STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| EN 1064:2005+A1:2007 | Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| EN 60601-2-4:2011 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| CEI EN 60601-2-4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| 07/30168606 DC : 0 | BS ISO 11073-91064 - HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 91064: STANDARD COMMUNICATION PROTOCOL - COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
| BS EN 60601-2-4:2011 | Medical electrical equipment Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| AAMI IEC 60601-2-4 : 2010 : R2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| AAMI EC11 : 1991 | DIAGNOSTIC ELECTROCARDIOGRAPHIC DEVICES |
| AAMI DF2 : 3ED 96 | CARDIAC DEFIBRILLATOR DEVICES |
| IEC 60601-2-4:2010+AMD1:2018 CSV | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| CSA C22.2 No. 60601.2.4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| CSA C22.2 No. 60601.2.4 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| AAMI EC53 : 2013 | ECG TRUNK CABLES AND PATIENT LEADWIRES |
| AAMI EC13 : 2002 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
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