AAMI EC12 : 2000 : R2005

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.