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Page: Regulation
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Diagnostic sonography is regulated in the USA by the FDA, and world-wide by other national regulatory agencies. The FDA limits acoustic output using several metrics. Generally other regulatory agencies around the world accept the FDA-established guidelines.
The primary regulated metrics are MI (Mechanical Index) a metric associated with the cavitation bio-effect, and TI (Thermal Index) a metric associated with the tissue heating bio-effect. The FDA requires that the machine not exceed limits that they have established. This requires the manufacturer to calibrate their machines and make them self-regulating. The established limits are reasonably conservative and therefore maintains diagnostic ultrasound as a safe imaging modality.
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Important notice:
The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other
qualified health provider with any questions you may have regarding a medical condition.
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