ISO 18189:2016
Ophthalmic optics — Contact lenses and contact lens care products — Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
Iso 18189:2016 describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions.
NOTE The potential of a contact lens or a contact lens care solution to cause cytotoxicity by itself can be evaluated in accordance with general guidance in ISO 10993‑5.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Direct contact cytotoxicity test for lens/lens care solution combination
5.1 General
5.2 Experimental procedure
5.2.1 Basic procedure
5.2.2 Material
5.2.3 Preparation of test sample
5.2.4 Methods
6 Assessment of results
7 Test report
Annex A (normative) Measurement of zone of cell lysis for the direct contact cytotoxicity test method for testing contact lens in combination with lens care solution
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Direct contact cytotoxicity test for lens/lens care solution combination
5.1 General
5.2 Experimental procedure
5.2.1 Basic procedure
5.2.2 Material
5.2.3 Preparation of test sample
5.2.4 Methods
6 Assessment of results
7 Test report
Annex A (normative) Measurement of zone of cell lysis for the direct contact cytotoxicity test method for testing contact lens in combination with lens care solution
Bibliography