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Safety and performance testing according to international standards and regulatory environment for medical ultrasound devices

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Besides being scientifically interesting, acoustics resp. ultrasonics has a broad and diverse range of applications in industry and the medical field. Acceptance of technology and its application depend on safety… Click to show full abstract

Besides being scientifically interesting, acoustics resp. ultrasonics has a broad and diverse range of applications in industry and the medical field. Acceptance of technology and its application depend on safety and performance of technology resp. devices utilizing it. Standardization is essential to ensure safety and performance and it also helps to harmonize market access of devices all around the world. To keep up with the “state of the art” it is necessary to continuously update existing standards and develop new ones. Especially in medical ultrasound a unique combination of expertise from different scientific areas is needed to develop useful standards: In addition to acoustics, physics and HF engineering, aspects of bioeffects and measurement technology need to be represented in standard development. The presentation will give insights how such combination of expertise contributed to the current set of medical ultrasound standards and what technical and scientific challenges need to be solved for d...

Keywords: acoustics; medical ultrasound; performance testing; safety performance

Journal Title: Journal of the Acoustical Society of America
Year Published: 2017

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