AAMI EC13 : 2002

Committee representation
Foreword
1 Scope
   1.1 Inclusions
   1.2 Exclusions
   1.3 Differences in monitors
2 Normative references
3 Definitions
4 Requirements
   4.1 Labeling requirements
       4.1.1 Device markings
       4.1.2 Operator manual
       4.1.3 Service manual
       4.1.4 Pacemaker pulse rejection capability
       4.1.5 Summary
   4.2 Performance requirements
       4.2.1 Operating conditions
       4.2.2 Overload protection
       4.2.3 Leakage current
       4.2.4 Auxiliary output
       4.2.5 Respiration, leads-off sensing,
              and active noise suppression
       4.2.6 QRS detection
       4.2.7 Range and accuracy of heart rate meter
       4.2.8 Alarm systemty
       4.2.9 Special requirements for monitors with
              ECG waveform display capability
       4.2.10 Electromagnetic compatibility
       4.2.11 Summary
5 Test methods
   5.1 Compliance with the labeling requirements
       5.1.1 Device markings
       5.1.2 Operator manual
       5.1.3 Service manual
       5.1.4 Pacemaker pulse rejection capability
   5.2 Compliance with the performance requirements
       5.2.1 Operating conditions
       5.2.2 Overload protection
       5.2.3 Leakage current
       5.2.4 Auxiliary output
       5.2.5 Respiration, leads-off sensing, and
              active noise suppression
       5.2.6 QRS detection
       5.2.7 Range and accuracy of heart rate meter
       5.2.8 Alarm system
       5.2.9 Special requirements for monitors with
              ECG waveform display capability
       5.2.10 Electromagnetic compatibility
Annexes
A - Rationale for the development and provisions of
    this standard
B - Cited references and bibliography
C - CMR test fixture design and application notes
D - Pacer pulse shaper test circuit and notes

Describes minimum safety and performance requirements for electrocardiographic (ECG) heart rate and waveform monitors.