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BSI
BS EN ISO 14730:2014

BS EN ISO 14730:2014

Current

Current

The latest, up-to-date edition.

Ophthalmic optics. Contact lens care products. Antimicrobial preservative efficacy testing and guidance on determining discard date

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2014

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Test methods
Annex A (informative) - Example of a membrane
        filtration procedure II
Annex B (informative) - Discard date procedure I
Annex C (informative) - Discard date procedure
Annex D (informative) - Discard date procedure III
Annex E (informative) - Discard date procedure IV
Annex F (informative) - Test organisms from other
        culture collections
Bibliography

Gives a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods for determination of discard date as informative annexes.

This International Standard specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods 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).

NOTE1 Principles of the test can be used to extend discard dating beyond 28d. See AnnexesB, C, D and E.

NOTE2 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.

Committee
CH/172/9
DevelopmentNote
Supersedes 98/564794 DC and BS 7208-3(1992). (05/2005) Supersedes BS 7208-25(2000). (10/2014)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO 18369-1:2017 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements

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PDF - English
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