EN ISO 14730-2014 en Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date《眼科光学 接触镜片护理品 抗菌防护效能试验和测定报.pdf

1、BSI Standards PublicationBS EN ISO 14730:2014Ophthalmic optics Contact lens care products Antimicrobial preservativeefficacy testing and guidanceon determining discard dateBS EN ISO 14730:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO14730:2014. It sup

2、ersedes BS EN ISO 14730:2000 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/9, Contact lenses and contact lens care products.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does n

3、ot purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 84870 4ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obli

4、gations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14730 October 2014 ICS 11.040.70 Supersedes EN ISO 14730:2000

5、English 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 contact - Essais de lefficacit de conservation antimicrobienne et lignes d

6、irectrices pour la dtermination de la dure dutilisation aprs premire ouverture (ISO 14730:2014) Augenoptik - Kontaktlinsenpflegemittel - Konservierungsmittelbelastungstest und Anleitung zur Feststellung der Aufbrauchfrist (ISO 14730:2014) This European Standard was approved by CEN on 23 July 2014. C

7、EN 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 bibliographical references concerning such national standards may be obtained on ap

8、plication 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 responsibility of a CEN member into its own language and notified to the CEN-CENELEC

9、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 of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

10、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue M

11、arnix 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 EBS EN ISO 14730:2014EN ISO 14730:2014 (E) 3 Foreword This document (EN ISO 14730:2014) has been prepared by Technical Committee ISO/TC 1

12、72 “Optics and photonics” in collaboration with Technical Committee 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 20

13、15, and conflicting national standards shall be withdrawn at the 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.

14、 This document supersedes EN ISO 14730:2000. According to the 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, Forme

15、r Yugoslav Republic 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 the United Kingdom. Endorsement notice The text of ISO 14730:2

16、014 has been approved by CEN as EN ISO 14730:2014 without any modification. BS EN ISO 14730:2014ISO 14730:2014(E)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 15 Test methods . 25.1 Materials and reagents . 25.2 Test sampling and cult

17、ure maintenance . 25.3 Preparation of microbial challenge (Inoculum) . 35.4 Inoculum challenge test procedure . 35.5 Controls . 55.6 Performance criteria 55.7 Test report . 6Annex A (informative) Example of a membrane filtration procedure II . 7Annex B (informative) Discard date procedure I . 9Annex

18、 C (informative) Discard date procedure 12Annex D (informative) Discard date procedure III .16Annex E (informative) Discard date procedure IV.19Annex F (informative) Test organisms from other culture collections 22Bibliography .23 ISO 2014 All rights reserved iiiBS EN ISO 14730:2014ISO 14730:2014(E)

19、ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a te

20、chnical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters

21、of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This documen

22、t was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such

23、 patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does

24、 not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informat

25、ionThe committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments in collaboration with the Technical Committee CEN/TC 170, Ophthalmic optics.This second edition cancels and replaces the first edition (ISO 14730:2000), of which i

26、t constitutes a minor revision.iv ISO 2014 All rights reservedBS EN ISO 14730:2014ISO 14730:2014(E)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

27、function, while others are multifunctional.Usually, products manufactured for use with 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.Mo

28、st CLCPs are manufactured as solutions and are commonly packaged and sold in multidose 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 its

29、elf, an antimicrobial preservative can be added to the product to inhibit the growth 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 co

30、ncentration of the preservative should be such that it provides adequate preservative 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. Typica

31、lly, ophthalmic preparations are packaged in small-volume containers and are used for 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

32、care products are the solution/lens interaction causing ocular irritation and the risks 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

33、to be weighed against the benefits of safety derived from the maintenance of the antimicrobial 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 the

34、ir test procedure of 28 d. The informative annexes give four examples of preservative efficacy test procedures developed by contact lens care product manufacturers to show preservative efficacy for products whose discard dates are over 28 d. ISO 2014 All rights reserved vBS EN ISO 14730:2014BS EN IS

35、O 14730:2014Ophthalmic optics Contact lens care products Antimicrobial preservative efficacy testing and guidance on determining discard date1 ScopeThis International Standard specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact le

36、ns 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 p

37、hysical 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 inclusion of contact lenses or other organic load can influence

38、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 sco

39、pe 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 applies. For undated references, the latest edition of the referen

40、ced 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 and recommendations for labelling specifications3 Terms and defin

41、itionsFor 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 the test and then rechallenging at day 14. The inoculated preparat

42、ions 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 peri

43、ods.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.INTERNATIONAL STANDARD ISO 14730:2014(E) ISO 201

44、4 All rights reserved 1BS EN ISO 14730:2014ISO 14730:2014(E)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 and a

45、t 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 and rea

46、gents5.1.1 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 10231Asp

47、ergillus 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 2 160

48、 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 equipme

49、ntThe 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 maintenanceThe 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.2 ISO 2014 All rights reservedBS EN ISO 14730:2014ISO 14730:2014(E)Thre