BS EN ISO 14730-2000 Ophthalmic optics – Contact lens care products – Antimicrobial preservative efficacy testing and guidance on determining discard date.
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 to be used 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).
NOTE 1 Pnnciples of the test may be used to extend discard dating beyond 28 days. See annexes B, C, D and E.
NOTE 2 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 may be of value in developing a contact lens care product, but are excluded from the scope of this International Standard.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of. any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and lEG maintain registers of currently valid International Standards.
ISO 8320.2:__1), Contact lenses and contact lens care products — Vocabulary — Part 2: Contact lens care products.
ISO 14534:1997, Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements.
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 8320-2 apply.
4.1 The test consists of challenging the preparation with a specified inoculum of suitable microorganisms at the commencement of the test and then rechallenging at day 14. The inoculated preparations are stored at a specified temperature. Samples are withdrawn from the inoculated preparations at specified time intervals and are cultured for determination of viable organisms. The capability of the product to prevent re-growth is confirmed by counting of viable organisms over longer time periods.
4.2 The size of the microbial challenge chosen in this test is not intended to be representative of the likely challenge in practice, but to provide countable numbers from which estimation of the rate and extent of viability loss can be determined.
4.3 The antimicrobial preservative properties of the product are adequate it, in the conditions of the test, there is significant reduction of bacteria and no increase in yeasts and moulds in the inoculated preparation after the times and at the temperatures specified, The performance criteria are given in 5.6.
4.4 Appropriate measures shall be taken to inactivate or remove residual antimicrobial agents during culturing and counting of survivors. The effectiveness of these measures shall be validated.
5 Test methods
5.1 MaterIals and reagents
5.1.1 Test organisms.
The strains listed in Table 1 shall be used.
NOTE Test organisms from other culture collections that may be used are listed in Annex F.BS EN ISO 14730 pdf download.