AAMI PC69 : 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Hardcopy , PDF
24-11-2012
English
01-01-2007
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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 45502-2-3:2010 | 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 |
| 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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