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Recommended ultrasound field safety classification for medical diagnostic devices.

Preston, R C; Shaw, A (2001) Recommended ultrasound field safety classification for medical diagnostic devices. Measurement Good Practice Guide. 50

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Ultrasound has been used intensively in our hospitals for over twenty years and it continues to command an ever increasing share of the diagnostic imaging market with tens of millions of ultrasound examinations being undertaken in the EC each year. Acoustic output levels of diagnostic ultrasonic systems have increased over the years and it has always been recognised that there is potential for adverse biological effects during clinical examination. The aim of this Guide is to provide some basic principals for assessing the safety of medical diagnostic ultrasonic fields, a topic of great importance to the patient, clinical user and manufacturer. The principals laid down are based on the quantitative assessment of two important biophysical end-points, temperature rise and the likelihood of cavitation taking place. A safety classification scheme is defined that establishes two simple classes of ultrasonic field safety. Class A is the highest safety class representing ultrasonic fields that can be used with minimal concern for patient safety. Class B relates to ultrasonic fields which require indication of additional information concerning thermal and cavitational hazard. Threshold levels of 4 kelvin for temperature rise and 4 megapascals for acoustic stress (peak rarefactional acoustic pressure) define the safety classes, and test methods needed to detemine these biophysical quantities are specified. Various options are provided for the declaration of the safety class for either ultasonic fields, modes of operation, probes or consoles. Finally, guidance on the use of the safety classes is given for patients and clinical operators.

Item Type: Report/Guide (Measurement Good Practice Guide)
Keywords: ultrasound, medical, safety
Subjects: Acoustics
Acoustics > Ultrasound
Last Modified: 02 Feb 2018 13:17
URI: http://eprintspublications.npl.co.uk/id/eprint/2113

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