Ala®sil chemical characterization and toxicity evaluation: an example of the need for the Medical Device Regulation 2017/745

Introduction: Ala®sil infusion was on the market for clinical use under the Medical Devices Directive (MDD) 93/42/EEC as an irrigating solution based on polydimethylsiloxane (PDMS). The product was withdrawn in 2016, and to the best of our knowledge, it did not cause any health damage.Methods: A bib...

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Κύριοι συγγραφείς:	Cristina Andrés-Iglesias, Ivan Fernandez-Bueno, Salvador Pastor-Idoate, Rosa M. Coco-Martin, J. Carlos Pastor
Μορφή:	Artigo
Γλώσσα:	Inglês
Έκδοση:	Frontiers Media S.A. 2024-01-01
Σειρά:	Frontiers in Pharmacology
Θέματα:	ophthalmic medical devices low-molecular-weight components toxicity silicone oil polydimethylsiloxane MDR
Διαθέσιμο Online:	https://www.frontiersin.org/articles/10.3389/fphar.2023.1310463/full
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