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BS ISO 14117:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Available format(s)

Hardcopy , PDF

Superseded date

09-04-2019

Language(s)

English

Published date

03-31-2013

Publisher

British Standards Institution

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Superseded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 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 45502-2-2 : 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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Hardcopy - English
PDF - English
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