Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Sets Lower Limits Than ISO For Endotoxins In Fluids Used In Intraocular Lens Surgeries

This article was originally published in The Gray Sheet

Executive Summary

A new FDA guidance calls for adopting a limit of less than or equal to 0.2 endotoxin units/mL for release testing of ophthalmic viscosurgical devices used in IOL surgeries. The limit is less than what the International Organization for Standardization (ISO) calls for to control Toxic Anterior Segment Syndrome.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT034151

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel