ISO 14117:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
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09-05-2019
English
07-10-2012
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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Withdrawn
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| 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 45502-2-2 : 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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