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ISO 14117:2012

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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 , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

09-05-2019

Language(s)

English

Published date

07-10-2012

Publisher

International Organization for Standardization

ISO 14117:2012 specifies 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.

It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:

0 Hz ≤ f < 450 MHz;

450 MHz ≤ f ≤ 3 000 MHz.

ISO 14117:2012 also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.

DevelopmentNote
DRAFT ISO/DIS 14117 is also available for this standard. (03/2018)
DocumentType
Standard
Pages
97
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

Standards Relationship
AAMI ISO 14117 : 2012 Identical
BS ISO 14117:2012 Identical
NEN ISO 14117 : 2012 Identical

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
EN 50527-2-2:2018 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)
ISO/PAS 19363:2017 Electrically propelled road vehicles Magnetic field wireless power transfer Safety and interoperability requirements
17/30359914 DC : 0 BS EN 50527-2-2 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
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
PREN 50527-2-2 : DRAFT 2017 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
ISO 14708-7:2013 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
ASTM F 3020 : 2016 Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security
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
ASTM F 2401 : 2016 : REDLINE Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
PREN 50527-2-1 : DRAFT 2015 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 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
15/30321270 DC : 0 BS EN 50527-2-1 - 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
ANSI/AAMI/ISO 14708-3:2017 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
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
ASTM F 3278 : 2017 Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security

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
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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