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AAMI PC69 : 2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Available format(s)

Hardcopy , PDF

Superseded date

11-24-2012

Language(s)

English

Published date

01-01-2007

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.

Committee
PC
DocumentType
Standard
Pages
97
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

BS EN 60601-2-31 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
EN 50527-2-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers
ISO 14117:2012 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
NF EN 45502-2-1 : 2004 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS)
I.S. EN 60601-2-31:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
CSA ISO/IEC TR 20017:14 (R2019) Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators (Adopted ISO/IEC TR 20017:2011, first edition, 2011-12-15)
BS ISO 14117:2012 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
I.S. EN 45502-2-2:2008 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
AAMI ISO 27186 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
11/30243761 DC : 0 BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
BS EN 50527-2-1:2016 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Specific assessment for workers with cardiac pacemakers
BS EN 45502-2-3:2010 Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems
BS ISO 27186:2010 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
BS EN 45502-2-1:2003 Active implantable medical devices Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
CSA C22.2 No. 60601-2-31 : 2009 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
UNE-EN 50527-2-1:2012 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers
CSA C22.2 No. 60601-2-31:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
BIS IS/ISO 14708-3 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
BS EN 45502-2-2:2008 Active implantable medical devices Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
IEEE C95.1-2345-2014 IEEE Standard for Military Workplaces--Force Health Protection Regarding Personnel Exposure to Electric, Magnetic, and Electromagnetic Fields, 0 Hz to 300 GHz
ISO 14708-6:2010 Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 27186:2010 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
UNI CEI EN 45502-2-3 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
TR 102 756 : 1.1.1 ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); SYSTEM REFERENCE DOCUMENT FOR REVISED SPECTRUM REQUIREMENTS FOR RFID EQUIPMENT AND INDUCTIVE LOOP SYSTEMS OPERATING IN THE FREQUENCY RANGE OF 9 KHZ TO 148,5 KHZ
CSA C22.2 No. 60601-2-31 : 2009 : INC : AMD 1 : 2014 : MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
AAMI ISO 14708-4 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
IEEE C95.1-2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz
ISO/IEC TR 20017:2011 Information technology Radio frequency identification for item management Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators
OVE/ONORM EN 60601-2-31 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE (IEC 60601-2-31:2008 + A1:2011)
ISO 14708-4:2008 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps
I.S. EN 50527-2-1:2016 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIAC PACEMAKERS
IEC 60601-2-31:2008+AMD1:2011 CSV Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
EN 60601-2-31:2008/A1:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
07/30165025 DC : 0 BS EN 60601-2-31 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
AAMI ISO 14708-4:2008(R2011) IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
I.S. EN 45502-2-3:2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
I.S. EN 45502-2-1:2004 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS)
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)

IEEE C95.1-2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz
IEEE C95.6-2002 IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz
EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
PREN 45502-2-2 : DRAFT 1998 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)

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