We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Safety Assessment of an A‐Scan Ultrasonic System for Ophthalmic Use.
- Authors
Petrella, Lorena; Fernandes, Paulo; Santos, Mário; Caixinha, Miguel; Nunes, Sandrina; Pinto, Carlos; Morgado, Miguel; Santos, Jaime; Perdigão, Fernando; Gomes, Marco
- Abstract
Objectives: 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. Methods: 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 IEC 62359:2010. The uncertainty on measurements was delineated in agreement with the guide JCGM 100:2008. Results: After risk management, all risks were qualitatively classified as acceptable. The mechanical index (0.08 ± 0.05), soft tissue thermal index (0.08 ± 0.08) and spatial‐peak temporal‐average intensity (0.56 ± 0.59 mW/cm2) were under the maximum index values indicated by the US Food and Drug Administration guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (0.23, 1, and 17 mW/cm2, respectively). Conclusions: This study presents a practical approach for the safety assessment of A‐scan ultrasonic systems for ophthalmic use. The safety evaluation of a medical device is mandatory before its use in clinical practice. However, the safety monitoring throughout its life cycle should also be considered, since many device components may deteriorate over time and use.
- Subjects
INTERNATIONAL Organization for Standardization; INTERNATIONAL Electrotechnical Commission; DIAGNOSTIC ultrasonic imaging; MEDICAL equipment; CATARACT; INTERNATIONAL organization; RISK management in business; EYE care
- Publication
Journal of Ultrasound in Medicine, 2020, Vol 39, Issue 11, p2143
- ISSN
0278-4297
- Publication type
Article
- DOI
10.1002/jum.15323