EN ISO 14729-2001 en Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact len.pdf

1、BRITISH STANDARDBS EN ISO 14729:2001BS 7208-26:2001Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lensesICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW+A1:2010

2、National forewordThis British Standard is the UK implementation of EN ISO 14729:2001+A1:2010. It is identical with ISO 14729:2001, incorporating amendment 1:2010. It supersedes BS EN ISO 14729:2001 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the

3、 text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by !“.The UK participation in its preparation was entrusted by Technical Committee CH/78, Ophthalmic optics, to Subcommittee CH/78/4 Contact lenses and

4、contact lens products.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard can

5、not confer immunity from legal obligations.BS EN ISO 14729:2001+A1:2010This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on15 July 2001 BSI 2011Amendments/

6、corrigenda issued since publicationDate Comments 31 January 2011 Implementation of ISO amendment 1:2010 with CEN endorsement A1:2010ISBN 978 0 580 6 23 455EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14729:2001+A1October 2010ICS 11.040.70English versionOphthalmic optics - Contact lens care

7、products - Microbiologicalrequirements and test methods for products and regimens forhygienic management of contact lenses (ISO 14729:2001)Optique ophtalmique - Produits dentretien des lentilles decontact - Exigences microbiologiques et mthodes dessaides produits et protocoles dentretien des lentill

8、es decontact (ISO 14729:2001)Augenoptik - Kontaktlinsenpflegemittel - MikrobiologischeAnforderungen und Prfverfahren fr Produkte undSysteme zum Hygienemanagement von Kontaktlinsen (ISO14729:2001)This European Standard was approved by CEN on 15 April 2001.CEN members are bound to comply with the CEN/

9、CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any C

10、EN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN member

11、s are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUR

12、OPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2001 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14729:2001 EForewordThe text of the International Standard ISO 14729:2001 has been prepared by

13、 TechnicalCommittee ISO/TC 172 “Optics and optical instruments” in collaboration with TechnicalCommittee 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 publicationof an identical text or by en

14、dorsement, at the latest by October 2001, and conflicting nationalstandards shall be withdrawn at the latest by October 2001.According to the CEN/CENELEC Internal Regulations, the national standards organizationsof the following countries are bound to implement this European Standard: Austria, Belgi

15、um,Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom.Endorsement noticeThe text of the International Standard ISO 14729:2001 was approved by CEN as a EuropeanStandard without

16、any modification.Foreword to amendment A1 The text of this Amendment EN ISO 14729:2001/A1:2010 to the EN ISO 14729 from Technical Committee ISO/TC 172 “Optics and photonics” of the International Organization for Standardization (ISO) has been taken over as an amendment to the European Standard by Te

17、chnical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 14729:2001 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2011, and conflic

18、ting national standards shall be withdrawn at the latest by April 2011. 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. According to t

19、he 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvi

20、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14729:2001/Amd.1:2010 has been approved by CEN as a EN ISO 14729:2001/A1:2010 without any modification. BS EN ISO

21、 14729:2001+A1:2010EN ISO 14729:2001+A1:2010 (E)Reference numberISO 14729:2001(E)INTERNATIONALSTANDARDISO14729First edition2001-04-15Ophthalmic optics Contact lens careproducts Microbiological requirementsand test methods for products andregimens for hygienic management ofcontact lensesOptique ophta

22、lmique Produits dentretien des lentilles de contact Exigences microbiologiques et mthodes dessai des produits et protocolesdentretien des lentilles de contactii BS EN ISO 14729:2001+A1:2010EN ISO 14729:2001+A1:2010 (E)iiiContents PageForeword.ivIntroduction.v1 Scope 12 Normative references 13 Terms

23、and definitions .14 Principle24.1 General24.2 Stand-alone test (Inoculum challenge test) 24.3 Regimen test 35 Performance requirements.35.1 Stand-alone test: Primary criteria (see also Table 1) 35.2 Stand-alone test: Secondary criteria (see also Table 1) .45.3 Regimen test: Regimen criteria (see als

24、o Table 1)46 Test methods56.1 Materials and reagents56.2 Preparation of microbial challenge (Inoculum) 66.3 Stand-alone procedure76.4 Regimen procedure .10Annex A (informative) Test organisms from other culture collections .13Annex B (informative) Example of a membrane filtration procedure 14Annex C

25、 (informative) Technical report: Virus testing16Annex D (informative) Technical report: Acanthamoeba testing .17Annex E (informative) Technical report: Artificial tears (organic soil) in laboratory testing 18Bibliography19BS EN ISO 14729:2001+A1:2010EN ISO 14729:2001+A1:2010 (E)iv ForewordISO (the I

26、nternational Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee ha

27、s been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical sta

28、ndardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.Publication as an International Standard requires approval by at leas

29、t 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this International Standard may be the subject ofpatent rights. ISO shall not be held responsible for identifying any or all such patent rights.International Standard ISO 14729 was prepared

30、by Technical Committee ISO/TC 172, Optics and opticalinstruments, Subcommittee SC 7, Ophthalmic optics and instruments.Annexes A to E of this International Standard are for information only.BS EN ISO 14729:2001+A1:2010EN ISO 14729:2001+A1:2010 (E)vIntroductionProducts for contact lens disinfection b

31、y chemical means are intended to reduce microbial contaminationintroduced during lens wear and removal, cleaning and storage and are required to contain antimicrobial agentscapable of achieving this.It is essential that all liquid contact lens care products are sterile until opened. Dry products (ta

32、blets, granules, etc.)should be subject to control of microbial contamination and should be dissolved in a suitable diluent immediatelyprior to use. Multidose contact lens care products must be adequately preserved or be packaged in a containerdesigned and labelled to minimize the risk of injury res

33、ulting from in-use contamination.Contact lenses are normally subject to a regimen of cleaning and contact lens disinfection between periods ofwear. Aqueous solutions containing cleaning and/or disinfecting agents are commonly used for this purpose. Theseproducts may be marketed as solutions or as ta

34、blets for dissolution immediately prior to use in a suitable diluentsuch as saline.The past 20 years of experience in the use and regulation of contact lens disinfecting products has shown distinctdisinfecting antimicrobial criteria for this class of medical devices. Ocular toxicology concerns, proc

35、ess convenienceand product comfort on the eye, have meant an evolution of products which maintain a low incidence of contactlens associated ocular infection when used as instructed by the manufacturer. This International Standard givesthese distinct contact lens disinfecting antimicrobial criteria a

36、long with annexes to explain why viruses (annex C)and Acanthamoeba (annex D) are not included as challenges. Organic soil is not required for evaluation of contactlens care disinfecting products but may be used; an informative annex (annex E) is included to discuss organic soilin the context of cont

37、act lenses and contact lens care products.BS EN ISO 14729:2001+A1:2010EN ISO 14729:2001+A1:2010 (E)INTENRATIONAL TSANDADR ISO 92741:(1002)E1Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products andregimens for hygienic management of contact lenses1 S

38、copeThis International Standard specifies two test methods for evaluating the antimicrobial activity of products to bemarketed for contact lens disinfection by chemical means and for products that are part of a contact lens careregimen.This International Standard is not applicable to the hygienic ma

39、nagement of trial lenses.NOTE General disinfection product standards are not applicable to contact lens care products, e.g. EN 1040:1997 andEN 1275:1997.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis Inte

40、rnational Standard. For dated references, subsequent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreements based on this International Standard are encouraged toinvestigate the possibility of applying the most recent editions of the normative documents

41、 indicated below. Forundated references, the latest edition of the normative document referred to applies. Members of ISO and IECmaintain registers of currently valid International Standards.3 Terms and definitions3.1contact lens disinfecting productproduct that possesses cidal activity (kills, dest

42、roys and/or inactivates) meeting the primary criteria of the stand-alone test specified in this International Standard3.2contact lens disinfecting regimencontact lens care regimen designed to meet both the secondary criteria of the stand-alone test and the regimen testas specified in this Internatio

43、nal StandardISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications !“For the purposes of this document, the terms and definitions given in ISO 18369-1 and the following apply.! “BS EN ISO 14729:2001+A1:2010EN ISO 14729

44、:2001+A1:2010 (E)2 3.3contact lens disinfectionchemical or physical process to reduce the number of viable microorganisms as specified in the performancerequirement sections of this International Standard4Principle4.1 GeneralThe stand-alone test is designed to qualify individual solutions with a sui

45、table level of antimicrobial activity ascontact lens disinfection products. The regimen test is designed to qualify individual solutions as part of a contactlens disinfecting regimen. Products meeting the regimen test criteria shall also meet the minimum performancerequirements of the stand-alone te

46、st. It is fundamental that such products (unopened containers) are capable ofmeeting the requirements of the test throughout their labelled shelf life.As described in Figure 1, contact lens care solutions which are designed to possess disinfecting properties shall betested in the stand-alone test fi

47、rst. If the respective primary criteria are met (see 5.1), the product may be labelledas a contact lens disinfecting product. If the product fails the primary criteria of the stand-alone test, the productmust exhibit sufficient antimicrobial activity to meet the secondary criteria of the stand-alone

48、 test as listed in 5.2. Ifthese secondary criteria are met, the regimen test shall be performed in order to qualify the product as part of acontact lens disinfecting regimen by meeting the regimen criteria (see 5.3). If the product meets both the secondarycriteria of the stand-alone test and the reg

49、imen test but fails the primary criteria of the stand-alone test, it shall belabelled as part of a contact lens disinfecting regimen.The design of contact lens care products for cleaning and contact lens disinfection shall take into consideration theneeds of patient compliance and the probability of non-compliance. For example, disinfecting time must beappropriate for contact lens wear.NOTE 1 Use of multiple or mixed microbial challenges can influence the apparent disinfecting activity of a particular product.The evaluation of these variables together wi