UNE EN ISO 14730:2014
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
Óptica oftálmica. Productos para el mantenimiento de las lentes de contacto. Ensayos de la eficacia de conservación antimicrobiana y recomendaciones para la determinación del periodo de validez previsto una vez abierto el envase. (ISO 14730:2014).
| Označení normy: | UNE EN ISO 14730:2014 |
| Počet stran: | 33 |
| Vydáno: | 2014-12-23 |
| Status: | Norma |
| Počet stran (Španělsky): | 36 |
UNE EN ISO 14730:2014
This International Standard specifies a procedure 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 can be used to extend discard dating beyond 28 d. 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 can be of value in developing a contact lens care product, but are excluded from the scope of this International Standard.
