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

ISO 18259:2014 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.

Optique ophtalmique — Produits d'entretien de lentilles de contact — Méthode d'évaluation des produits d'entretien des lentilles de contact avec les lentilles de contact dans leur étui, en présence de contamination par des bactéries et champignons

General Information

• Status: Published
• Publication Date: 22-Sep-2014
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
• Drafting Committee: ISO/TC 172/SC 7/WG 9 - Contact lenses
• Current Stage: 9020 - International Standard under periodical review
• Start Date: 15-Apr-2024
• Completion Date: 15-Apr-2024

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18259
First edition
2014-10-01
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
Optique ophtalmique — Produits d’entretien de lentilles de contact
— Méthode d’évaluation des produits d’entretien des lentilles de
contact avec les lentilles de contact dans leur étui, en présence de
contamination par des bactéries et champignons
Reference number
ISO 18259:2014(E)
©
ISO 2014

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ISO 18259:2014(E)

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ii © ISO 2014 – All rights reserved

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ISO 18259:2014(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Rationale . 2
6 Methodology . 2
6.1 General . 2
6.2 Test procedure . 2
7 Performance criteria . 4
Annex A (normative) Preparation of challenge organisms in organic soil . 5
Bibliography . 7
© ISO 2014 – All rights reserved iii

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ISO 18259:2014(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance wi
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