ISO 14729

Ophthalmic optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses

Summary

For contact lens wearers, disinfection of the lenses between uses is very important.  The ISO 14729 outlines the test method to evaluate microbicidal activities of contact lens care solution products, by both the “stand-alone” (i.e., suspension test without the use of contact lenses) and “regimen” (i.e., simulated use involving actual contact lenses) tests.  This test is designed to challenge contact lenses in contact lens solution either alone or in conjunction with a disinfection regimen against bacteria, fungi or other micro-organisms (e.g., acanthamoeba or viruses).  

Typical Test Substances

• Contact lens care solutions

Outline of Test Procedure

Stand-alone test:

• Mix microorganism with test solution
• Hold for contact time (usually several hours)
• Add Neutralizer 
• Plating and Counting (quantitative assay)

Regimen test:

• Inoculate microorganism onto contact lens and allow dry
• Treat lens with test solution following stipulated regimen 
• Elute off microorganism from lens into neutralizer
• Plating and Counting (quantitative assay)

Regulatory Agencies / Purpose

• U.S. Food and Drug Administration (FDA)
• Other agencies 

Similar Methods

• ISO 19045