Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use.
PMID: 32459382 · 2020
JournalJournal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine
Year2020
PMID32459382
Abstract
This study describes the safety assessment of an A-scan ultrasonic system for ophthalmic use. The system is an investigational medical device for automatic cataract detection and classification. The risk management was based on the International Organization for Standardization (ISO) standard DIN EN ISO 14971:2009-10 and International Electrotechnical Commission (IEC) standard IEC 60601-2-37. The calibration of the ultrasonic field was conducted according to the standards IEC 62127-1:2007 and IE
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