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FDAnews Device Daily Bulletin
Oct. 9, 2012 | Vol. 9 No. 198
ISO to Contact Lens Manufacturers: Perform Risk-Based Shelf Life Tests
Contact lens manufacturers should tie risk assessments to the shelf life of their products to ensure they don’t deteriorate during storage and are safe and effective when used, a revised International Organization for Standardization (ISO) standard advises. The standard requires contact lens makers to perform a risk assessment and then a test to determine the shelf life of their products. Under the old standard, shelf life was included in a broader contact lens risk management protocol.
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