BS ISO 14117:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Hardcopy , PDF
04-09-2019
English
31-03-2013
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions, symbols and abbreviations
4 Test requirements for the frequency band 0 Hz <= f
<= 3000 MHz
5 Testing above frequency of 3000 MHz
6 Protection of devices from EM fields encountered in
a therapeutic environment
7 Additional accompanying documentation
Annex A (informative) - Rationale
Annex B (informative) - Rationale for test frequency
ranges
Annex C (informative) - Code for describing modes of
implantable generators
Annex D (normative) - Interface circuits
Annex E (informative) - Selection of capacitor C[x]
Annex F (normative) - Calibration of the injection network
Annex G (normative) - Torso simulator
Annex H (normative) - Dipole antennas
Annex I (normative) - Pacemaker/ICD programming settings
Annex J (normative) - Simulated cardiac signal
Annex K (normative) - Calculation of net power into
dipole antenna
Annex L (informative) - Loop area calculations
Annex M (informative) - Correlation between levels of test
voltages used in this International Standard and
strengths of radiated fields
Bibliography
Describes test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization.
| Committee |
CH/150/2
|
| DevelopmentNote |
Supersedes 10/30208719 DC. (03/2013)
|
| DocumentType |
Standard
|
| Pages |
108
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14117:2012 | Identical |
| AAMI PC69 : 2007 | |
| 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) |
| EN 50061 : 88 AMD 1 95 | SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| IEEE C95.1-2005 | IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz |
| ANSI C63.5 : 2006 | ELECTROMAGNETIC COMPATIBILITY - RADIATED EMISSION MEASUREMENTS IN ELECTROMAGNETIC INTERFERENCE (EMI) CONTROL - CALIBRATION AND QUALIFICATION OF ANTENNAS (9 KHZ TO 40 GHZ) |
| IEEE C95.6-2002 | IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz |
| DIN VDE 0848-3-1 : DRAFT 2002 | SAFETY IN ELECTRICAL, MAGNETIC AND ELECTROMAGNETIC FIELDS - PART 3-1: PROTECTION OF PERSONS WITH ACTIVE IMPLANTS IN THE FREQUENCY RANGE 0 HZ TO 300 GHZ |
| 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) |
| 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) |
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