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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-06-2016

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Direct contact cytotoxicity test for lens/lens care
  solution combination
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

Specifies 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.

This International Standard 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 ISO10993-5.

Committee	CH/172/9
DevelopmentNote	Supersedes 15/30266276 DC. (06/2016)
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Current
Supersedes	15/30266276 DC : 0

Standards	Relationship
ISO 18189:2016	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 18369-1:2017	Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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BS 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

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory