DIN EN ISO 14729:2011

Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001 + Amd.1:2010); German version EN ISO 14729:2001 + A1:2010

The standard describes two test methods and the requirements to be used in evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. The 'stand alone test' is designed to qualify individual solutions with a suitable level of antimicrobial activity as contact lens disinfection products. The 'regimen test' is designed to qualify individual solutions as part of a contact lens disinfecting regimen.*The standard describes two test methods and requirements which shall be applied for evaluating the antimicrobial activity of products to bemarketed for contact lens disinfection by chemical means. The "stand alone test" is designed to qualify individual solutions with a suitable level of antimicrobial activity as contact lens disinfection products. The regimen test is designed to qualify individual solutions as part of a contact lens disinfecting regimen. Through Amendment A1:2010 which has now been incorporated into the standard, the criteria for moulds in the so-called "stand alone test" have been clarified, the test requirements with regard to the elimination of cleaning and/or rinsing steps have been changed and specifications have been layed down with regard to the testing of care products to be used for silicone hydrogel lenses. The standard primarily addresses the manufacturers of contact lens care products. The International Standard has been prepared by ISO/TC 172/SC 7 "Ophthalmic optics and instruments", in collaboration with CEN/TC 170 "Ophthalmic optics" (secretariat: both DIN). On the national level, the responsible Working Committee is NA 027-01-08 AA "Augenoptik" ("Ophthalmic optics"), Working Group "Kontaktlinsen" ("Contact lenses") of NAFuo.