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2725.1 - Standard for Microwave Structural, Vascular or Functional Medical Imaging Device Safety

The purpose of this standard is: * To specify the maximum allowable exposure of radio frequency (RF) energy to which the device exposes the human body and to further specify required means within the device to continually monitor such energy emission and to automatically shut down the device in the event these limits are exceeded. *To specify the electrical safety requirements, to ensure that in the event of any single-point failure, the device does not expose the subject to leakage currents exceeding a specified existing limit that is established as safe, such as the electrical safety parameters specified in IEC -60601. *To specify the electromagnetic compatibility (EMC) requirements of the device, to prevent interference with communications, and to prevent unintended transmission of patient data due to RF leakage. *In addition to the creation and approval of human safety and EMC requirements documents, this standard also defines the assurance program for evaluating and certifying products against those requirements.
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