ISO 18259:2014 PDF

Scope: This International Standard specifies an antimicrobial efficacy end point methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection. This provides a process for evaluating compatibility of solutions used for disinfection with contact lenses and lens cases using an antimicrobial efficacy end point. Specifically, the microbiological effect of the antimicrobial agent(s) while in the presence of the lens cases and/or lenses will be evaluated as described in the soak step of the label instructions. For practical purposes, this does not apply to oxidative systems.

ISO 18259:2014 Referenced Document

ISO 11986:2010 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
ISO 14729:2001 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 18369-1:2006 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 18369-3:2006 Ophthalmic optics - Contact lenses - Part 3: Measurement methods

2014 ISO 18259:2014 Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms