M00017081
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ISO FDIS 14730 2014 Edition, March 20, 2014 OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - ANTIMICROBIAL PRESERVATIVE EFFICACY TESTING AND GUIDANCE ON DETERMINING DISCARD DATE
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Availability date: 07/14/2021
Description / Abstract:
This International Standard specifies a procedure to be used in
evaluating the antimicrobial preservative activity of all preserved
multidose contact lens care products, and provides guidance on
methods to be used for determination of discard date as informative
annexes.
This test is applicable to products for up to a 28-day discard
date.
The test is not applicable to sterile products packaged in unit
doses for single use or multidose containers designed with physical
barriers to microbial contamination (e.g. aerosol containers).
NOTE 1 Principles of the test may be used to extend discard
dating beyond 28 days. See annexes B, C, D and E.
NOTE 2 Use of multiple or mixed microbial challenges and/or
inclusion of contact lenses or other organic load can influence the
apparent antimicrobial activity of a particular product. The
evaluation of these variables together with testing against a
larger panel of microorganisms and testing of samples from
partially used containers may be of value in developing a contact
lens care product, but are excluded from the scope of this
International Standard.