EM EXPOSURE ASSESSMENTS
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CERTIFICATION

 

 

Medical implant safety during MRI exposure has become an important research area

Medical implant safety during MRI exposure has become an important research area.

 

 

 

 

Certification

Background

Since its inception, the IT'IS Foundation has been at the forefront of developing instrumentation, methods, and procedures for international standards. We actively collaborate with standards groups to ensure that rigorous standards are implemented for evaluating compliance of products with electromagnetic exposure guidelines. We develop the necessary simulation and experimental tools for the standards, perform research to validate and continuously improve those tools, and contribute to the fast transition of research results into the certification process.

Selected Past Achievements

  • Pioneering research contributions to the development of international SAR measurement standards (IEC 62209 and IEEE 1528), including investigation of the fundamental absorption mechanism, the influence of tissue composition, and head and ear modeling
  • Improvements of measurement techniques leading to the development of SAR measurement systems (including probes and phantoms) and calibration setups
  • Publication of the first large scale study on the effect of the user's hand holding a mobile phone on the SAR in the head, providing clarity on the issue to standards committees
  • Development of instrumentation and robust procedures for ISO/TS 10974 to evaluate the safety of magnetic resonance imaging for patients with active implantable medical devices.
  • Development of novel hardware for the measurement of incident fields from Wireless Power Transfer systems, and transfer matrix for estimation of induced fields with respect to exposure limits.
  • Design of probe and scanning system for accurate measurement of 5G signals with respect to power density limits.
  • Collaboration with IEC and international consortium on validation and uncertainty analysis of SAR array systems. Design of reference sources representing a broad range of SAR distributions and field coupling mechanisms.

Next Challenges

The challenges of certification research are to identify the gaps where new standards are needed or need to be revised. Recent and ongoing projects include:

  • Development of practical and more reliable methods to evaluate the exposure of workers in high-current and high-voltage workplaces, for compliance with upcoming EU Directive 2004/40/EC
  • Development of procedures for exposure evaluation of 5G devices at frequencies above 6 GHz. Continue collaboration IEC on Technical Report and International Standard.
 

Current Standards Activities

IEEE C95.1: Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz

IEEE C95.3: Recommended Practice for Measurements and Computations of Electric, Magnetic, and Electromagnetic Fields with Respect to Human Exposure to Such Fields, 0 Hz to 100 kHz

ISO/TS 10974: Requirements for the safety and compatibility of magnetic resonance imaging for patients with an active implantable medical device

IEEE 1528: Recommended Practice for Determining the Peak Spatial-Average Specific Absorption Rate (SAR) in the Human Head from Wireless Communications Devices: Measurement Techniques

IEC 62704-1: Recommended Practice for Determining the Peak Spatial-Average Specific Absorption Rate (SAR) in the Human Body from Wireless Communications Devices, 30 MHz - 6 GHz - Part 1: General Requirements for using the Finite Difference Time Domain (FDTD) Method for SAR Calculations

IEC 62704-2: Recommended Practice for Determining the Peak Spatial Average Specific Absorption Rate (SAR) in the Human Body from Wireless Communications Devices, 30 MHz - 6 GHz - Part 2: Specific Requirements for Finite Difference Time Domain (FDTD) Modeling of Vehicle Mounted Antenna Configurations

IEC 62704-3: Recommended Practice for Determining the Peak Spatial-Average Specific Absorption Rate (SAR) in the Human Body from Wireless Communications Devices, 30 MHz - 6 GHz - Part 3: Specific Requirements for Finite Difference Time Domain (FDTD) Modeling of Mobile Phones/Personal Wireless Devices

IEC 62704-4:   Recommended Practice for Determining the Peak Spatial Average Specific Absorption Rate (SAR) in the Human Body from Wireless Communications Devices, 30 MHz - 6 GHz – Part 4: General Requirements for Using the Finite-Element Method (FEM) for SAR Calculations and Specific Requirements for Modelling Vehicle-Mounted Antennas and Personal Wireless Devices

IEC 62209 - Part 1: Human exposure to radiofrequency fields from wireless communication devices used in close proximity to the head or body - Human models, instrumentation and procedures - Part 1: Procedure to determine the specific absorption rate (SAR) for devices used in close proximity to the ear (frequency range of 300 MHz to 6 GHz)

IEC 62209 - Part 2: Human exposure to radiofrequency fields from wireless communication devices used in close proximity to the head or body - Human models, instrumentation and procedures - Part 2: Procedure to determine the specific absorption rate (SAR) for wireless communication devices used in close proximity to the human body (frequency range of 30 MHz to 6 GHz)

IEC 62209 - Part 3:  Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 3: Vector probe systems (Frequency range of 100 MHz to 6 GHz)

IEC 62232: Determination of RF field strength and SAR in the vicinity of radiocommunication base stations for the purpose of evaluating human exposure

IEC 62233: Measurement methods for electromagnetic fields of household appliances and

similar apparatus with regard to human exposure

IEC 60601-2-33: Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis American National Standard for Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids

ANSI C63.19: American National Standard for Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids

CTIA: Test Plan for Mobile Station Over the Air Performance: Method of Measurement for Radiated RF Power and Receiver Performance

     

 
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