1、February 2015 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.040.70!%B%“2293102www.din.deDDIN EN ISO 14730Ophthalmic optics Contact lens care products Antimicrobial preservative efficacy testing and guidance on determiningdiscard date (ISO 14730:2014);English version EN ISO 14730:2014,English translation of DIN EN ISO 14730:2015-02Augenoptik Kontaktlins
3、enpflegemittel Konservierungsmittelbelastungstest und Anleitung zur Feststellung der Aufbrauchfrist(ISO 14730:2014);Englische Fassung EN ISO 14730:2014,Englische bersetzung von DIN EN ISO 14730:2015-02Optique ophtalmique Produits dentretien des lentilles de contact Essais de lefficacit de conservati
4、on antimicrobienne et lignes directrices pour ladtermination de la dure dutilisation aprs premire ouverture (ISO 14730:2014);Version anglaise EN ISO 14730:2014,Traduction anglaise de DIN EN ISO 14730:2015-02SupersedesDIN EN ISO 14730:2001-08www.beuth.deDocument comprises 29 pagesIn case of doubt, th
5、e German-language original shall be considered authoritative.01.15 DIN EN ISO 14730:2015-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 14730:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics an
6、d instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), W
7、orking Committee NA 027-01-08 AA Augenoptik, Working Group 027-01-08-04 AK Kontaktlinsen. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 14534 DIN EN ISO 14534 ISO 18369-1 DIN EN ISO 18369-1 Amendments This standard differs from DIN EN
8、 ISO 14730:2001-08 as follows: a) normative references have been updated; b) the species of the test organism Aspergillus has been updated due to the reclassification of Aspergillus niger as Aspergillus brasiliensis. Previous editions DIN EN ISO 14730: 2001-08 National Annex NA (informative) Bibliog
9、raphy DIN EN ISO 14534, Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements DIN EN ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications EUROPEAN STANDARD NORME EUROPENNE EUROPISCH
10、E NORM EN ISO 14730 October 2014 ICS 11.040.70 Supersedes EN ISO 14730:2000English Version Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014) Optique ophtalmique - Produits dentretien des lentilles de
11、 contact - Essais de lefficacit de conservation antimicrobienne et lignes directrices pour la dtermination de la dure dutilisation aprs premire ouverture(ISO 14730:2014) Augenoptik - Kontaktlinsenpflegemittel - Konservierungsmittelbelastungstest und Anleitung zur Feststellung der Aufbrauchfrist (ISO
12、 14730:2014) This European Standard was approved by CEN on 23 July 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliogra
13、phical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibil
14、ity of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic
15、of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISAT
16、ION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14730:2014 EContents PageForeword 3Introduction 41 Scope . 52 Normative re
17、ferences 53 Terms and definitions . 54 Principle 55 Test methods . 65.1 Materials and reagents .65.2 Test sampling and culture maintenance .65.3 Preparation of microbial challenge (Inoculum) . 75.4 Inoculum challenge test procedure . 75.5 Controls . 95.6 Performance criteria 95.7 Test report 10Annex
18、 A (informative) Example of a membrane filtration procedure II 11Annex B (informative) Discard date procedure I 13Annex C (informative) Discard date procedure 16Annex D (informative) Discard date procedure III .20Annex E (informative) Discard date procedure IV.23Annex F (informative) Test organisms
19、from other culture collections 26Bibliography .27DIN EN ISO 14730:2015-02 EN ISO 14730:2014 (E) 2 DIN EN ISO 14730:2015-02 EN ISO 14730:2014 (E) 3Foreword This document (EN ISO 14730:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Comm
20、ittee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at t
21、he latest by April 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14730:2000. According to the
22、CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hun
23、gary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 14730:2014 has been approved by CEN as EN ISO 14730:2014 without any
24、modification. IntroductionContact lens care products (CLCP) are used with contact lenses. These products rinse, clean, disinfect, store, wet, aid the comfort of, and condition contact lenses. Some products have one function, while others are multifunctional.Usually, products manufactured for use wit
25、h hydrogel lenses may be used with rigid gas-permeable (RGP) or poly (methyl methacrylate) (PMMA) lenses, but products specifically used for RGP or PMMA contact lenses are not usually suitable for hydrogel lenses.Most CLCPs are manufactured as solutions and are commonly packaged and sold in multidos
26、e containers. Dry products are sold as tablets or granules and shall be dissolved in a suitable solvent immediately prior to use.If the contact lens care product solution does not have any antimicrobial activity itself, an antimicrobial preservative can be added to the product to inhibit the growth
27、of microorganisms that might be introduced from repeated dispensing during use and subsequent storage. All antimicrobial agents have the potential for toxicity to the user. For maximum protection to the user, the concentration of the preservative should be such that it provides adequate preservative
28、 activity with minimum toxicity.There are differences between ophthalmic preparations and contact lens care products and some of these differences are significant in relation to preservative efficacy testing. Typically, ophthalmic preparations are packaged in small-volume containers and are used for
29、 short periods on compromised eyes. Contact lens care products are distributed in larger volume containers and are used with contact lenses on a long term basis on healthy eyes. The potential risks for contact lens care products are the solution/lens interaction causing ocular irritation and the ris
30、ks of the solution contamination by the repeated (daily) use of the product.Thus, when contact lens care products are formulated, the risk of adverse patient reaction due to the lens and/or solution interaction has to be weighed against the benefits of safety derived from the maintenance of the anti
31、microbial activity of the solution.This International Standard gives the test procedure and performance criteria for preservative efficacy. It has been adapted from Pharmacopoeias which give a time limitation in their test procedure of 28 d. The informative annexes give four examples of preservative
32、 efficacy test procedures developed by contact lens care product manufacturers to show preservative efficacy for products whose discard dates are over 28 d.DIN EN ISO 14730:2015-02 EN ISO 14730:2014 (E) 4 1 ScopeThis International Standard specifies a procedure to be used in evaluating the antimicro
33、bial 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 u
34、nit doses for single use or multidose containers designed with physical barriers to microbial contamination (e.g. aerosol containers).NOTE 1 Principles of the test can be used to extend discard dating beyond 28 d. See Annexes B, C, D and E.NOTE 2 Use of multiple or mixed microbial challenges and/or
35、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 devel
36、oping a contact lens care product, but are excluded from the scope of this International Standard.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited ap
37、plies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 14534, Ophthalmic optics Contact lenses and contact lens care products Fundamental requirementsISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system a
38、nd recommendations for labelling specifications3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 18369-1 apply.4 Principle4.1 The test consists of challenging the preparation with a specified inoculum of suitable microorganisms at the commencement of th
39、e 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
40、 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 ca
41、n be determined.DIN EN ISO 14730:2015-02 EN ISO 14730:2014 (E) 5 4.3 The antimicrobial preservative properties of the product are adequate if, 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
42、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 methods5.1 Materials an
43、d reagents5.1.1 Test organismsThe strains listed in Table 1 shall be used.NOTE Test organisms from other culture collections that can be used are listed in Annex F.Table 1 Test organismsPseudomonas aeruginosa ATCC 9027Staphylococcus aureus ATCC 6538Escherichia coli ATCC 8739Candida albicans ATCC 102
44、31Aspergillus brasiliensis ATCC 164045.1.2 Culture media and reagents5.1.2.1 Tryptone Soya Agar (TSA).5.1.2.2 Sabouraud Dextrose Agar (SDA).5.1.2.3 Dulbeccos Phosphate-Buffered Saline, without calcium chloride and magnesium chloride (DPBS).Combine 200 mg/l KCl, 200 mg/l KH2PO4, 8 000 mg/l NaCl, and
45、2 160 mg/l Na2HPO4 7H2O or suitable diluent.5.1.2.4 Dulbeccos Phosphate Buffered Saline, plus 0,05 % volumic mass polysorbate 80 (DPBST) or suitable diluent.5.1.2.5 Validated neutralizing agents/media as required, for example, Dey-Engley Neutralizing Broth (DEB) and Letheen Broth.5.1.3 Laboratory eq
46、uipmentThe following common laboratory equipment is required: sterile pipettes, swabs, tubes, petri dishes (90 mm to 100 mm 20 mm), etc. and suitable instruments for spectrophotometric determination of cell density, for colony counting and for centrifugation.5.2 Test sampling and culture maintenance
47、The product to be tested shall be representative of the product to be marketed. Aliquots should be taken directly from the final product container immediately prior to testing.DIN EN ISO 14730:2015-02 EN ISO 14730:2014 (E) 6 Three lots of product shall be tested. Each lot of product shall be tested with a separate inoculum preparation for each challenge organism.Maintain the test cultures as recommended by the curator of the appropriate culture collection.Cultures should be no greater than five pas
