AAMI PC69 : 2007

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions, symbols, and abbreviations
4 Test requirements for the frequency band
  0 Hz <= f < 3,000 MHz
  4.1 General
  4.2 Induced lead current
      4.2.1 Pacemakers
      4.2.2 ICDs
  4.3 Protection from persisting malfunction
      attributable to continuous wave sources
      4.3.1 Pacemakers
      4.3.2 ICDs
  4.4 Temporary response to continuous wave sources
      4.4.1 Pacemakers
      4.4.2 ICDs
  4.5 Protection from sensing modulated EMI as cardiac
      signals
      4.5.1 Protection from sensing EMI as cardiac
            signals in the frequency range of
            16.6 Hz to 150 kHz
      4.5.2 Protection from sensing EMI as cardiac
            signals in the frequency range of 150 kHz
            to 10 MHz
      4.5.3 Protection from sensing EMI as cardiac signals
            in the frequency range of 10 MHz to 450 MHz
  4.6 Protection from static magnetic fields of flux
      density up to 1 mT
      4.6.1 Pacemakers
      4.6.2 ICDs
  4.7 Protection from static magnetic fields of flux
      density up to 50 mT
      4.7.1 Pacemakers
      4.7.2 ICDs
  4.8 Protection from AC magnetic field exposure in
      the range of 1 kHz to 140 kHz
      4.8.1 Pacemakers
      4.8.2 ICDs
  4.9 Test requirements for the frequency range of
      450 MHz <= f < 3,000 MHz
      4.9.1 General requirements
      4.9.2 Test setup
      4.9.3 Test procedure
      4.9.4 Performance criteria
5 Testing above frequency of 3,000 MHz
6 Protection of pacemakers and ICDs from EM
  fields encountered in a therapeutic environment
  6.1 Protection of the device from damage caused by
      high-frequency surgical exposure
      6.1.1 Pacemakers
      6.1.2 ICDs
  6.2 Protection of the device from damage caused by
      external defibrillators
      6.2.1 Pacemakers
      6.2.2 ICDs
Annexes
A - Rationale
B - Rationale for test frequencies
C - Code for describing modes of implantable generators
D - Interface circuits
E - Selection of capacitor Cx
F - Calibration of the injection network
G - Torso simulator
H - Dipole antennas
I - Pacemaker/ICD programming settings
J - Simulated cardiac signal
K - Calculation of net power into dipole antenna
L - Loop area calculations
M - Correlation between levels of test voltages used
    in the standard and strengths of radiated fields
N - Bibliography

Describes a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable cardiovascular devices.