BS ISO 18189:2016
Current
The latest, up-to-date edition.
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
Hardcopy , PDF
English
30-06-2016
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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
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.
| Committee |
CH/172/9
|
| DevelopmentNote |
Supersedes 15/30266276 DC. (06/2016)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| 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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