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AAMI EC12 : 2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

DISPOSABLE ECG ELECTRODES
Superseded date

04-10-2021

Published date

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Superseded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]
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
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
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
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

AAMI EC53 : 2013 ECG TRUNK CABLES AND PATIENT LEADWIRES
AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS

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