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Endotoxin Testing for Intraocular Devices by Ajay Kumar is a document available to read on EtoBox.

What is Endotoxin Testing for Intraocular Devices about?

This guidance document from the FDA provides recommendations for endotoxin limits and testing for intraocular devices and single-use intraocular surgical instruments/accessories. It aims to help prevent future outbreaks of toxic anterior segment syndrome (TASS), a sterile inflammatory eye condition associated with these medical devices. TASS has been linked to endotoxin contamination from manufacturing or packaging processes. The guidance establishes definitions for relevant device types and endotoxin, and

Author

Ajay Kumar

Language

EN