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Getting Under the Hood in the IR/Cath Lab: Utilizing New Standards for Performance Evaluations

K Wunderle1*, A Kuhls-Gilcrist2*, (1) Cleveland Clinic Foundation, Broadview Hts, OH, (2) Canon Medical Systems USA, Tustin, CA



Presentations

(Monday, 7/13/2020) 3:30 PM - 4:30 PM [Eastern Time (GMT-4)]

Room: Track 6

The medical imaging equipment community has recently produced 2 documents related to the safety and performance of x-ray equipment used for interventional procedures. This symposium will provide information on the contents of the National Electrical Manufacturers Association (NEMA) X-ray Standard #27. This standard defines a user quality control mode for interventional imaging equipment. It identifies the minimum requirements needed to perform quality control and testing on the equipment. Guidance on how some of the features in this “Physicist mode” may be used to facilitate testing of the x-ray output and other aspects of the system will be provided. In addition, this symposium will review the new International Electrotechnical Commission (IEC) standard on safety and performance of interventional imaging equipment. The latest update to this standard includes, among other thing, the definition of color maps to display estimated peak skin doses to operators during an exam. Both standards provide guidance to manufacturers on providing and implementing new tools which will be of particular use to the physics community, but it is important to remember that these features may only be available on newer equipment that has been updated or produced to conform to these standards.

Learning Objectives:
1. Understand the features required by NEMA XR-27 in the applicable equipment and how a physicist can utilize the physicist QC mode.
2. Understand the new requirements/suggestions in the latest version of the IEC standard for basic safety and essential performance of X-ray equipment for interventional procedures
3. Learn about the proposed color maps for estimated peak skin dose to be displayed during image guided interventions on equipment complying with the new IEC standard.
IEC 60601-2-43/AMD2 ED2: Amendment 2 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

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