EN ISO 14729:2001
(Main)Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001)
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001)
Specification of uniform test methods in order to achieve comparable test results.
Augenoptik - Kontaktlinsenpflegemittel - Mikrobiologische Anforderungen und Prüfverfahren für Produkte und Systeme zum Hygienemanagement von Kontaktlinsen (ISO 14729:2001)
Diese Internationale Norm beschreibt zwei Testverfahren sowie Anforderungen, die bei der Bewertung der antimikrobiellen Wirkung von Produkten anzuwenden sind, die zur chemischen Desinfektion von Kontaktlinsen vermarktet werden sollen. Der "Stand Alone Test" (Pflegemittel Direktprüfung) soll einzelne Lösungen mit eindeutig antimikrobieller Wirkung als Desinfektionsmittel für Kontaktlinsen qualifizieren. Der "Regimen Test" (Prüfung gemäß Pflegeanweisung) soll einzelne Lösungen als Teil einer umfassenden Pflegeanweisung zur Desinfektion von Kontaktlinsen qualifizieren.
Optique ophtalmique - Produits d'entretien des lentilles de contact - Exigences microbiologiques et méthodes d'essai des produits et protocoles d'entretien des lentilles de contact (ISO 14729:2001)
La présente Norme internationale décrit deux méthodes d'essai et les exigences devant être utilisées pour l'évaluation de l'activité antimicrobienne des produits destinés à être commercialisés pour la décontamination des lentilles de contact par des moyens chimiques, ainsi que des produits faisant partie d'un protocole d'entretien des lentilles de contact. La présente Norme internationale ne concerne pas l'entretien des lentilles expérimentales.
NOTE Les normes générales relatives aux produits de décontamination (par exemple l'EN 1040:1997 et l'EN 1275:1997) ne sont pas applicables aux produits d'entretien des lentilles de contact
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč – Mikrobiološke zahteve in preskusne metode za izdelke in postopki higienskega ravnanja s kontaktnimi lečami (ISO 14729:2001)
Ta mednarodni standard določa dve preskusni metodi za vrednotenje antimikrobne dejavnosti izdelkov, ki se tržijo za razkuževanje kontaktnih leč s kemičnimi sredstvi in izdelkov, ki so del postopkov nege kontaktnih leč. Ta mednarodni standard ne velja za higiensko ravnanje s poskusnimi lečami.
General Information
- Status
- Published
- Publication Date
- 14-Apr-2001
- Technical Committee
- CEN/TC 170 - Ophthalmic optics
- Drafting Committee
- CEN/TC 170 - Ophthalmic optics
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 20-May-2008
- Completion Date
- 20-May-2008
Relations
- Effective Date
- 28-Jan-2026
- Effective Date
- 12-Feb-2026
- Effective Date
- 22-Dec-2008
Overview
EN ISO 14729:2001 establishes standardized microbiological requirements and test methods for contact lens care products and regimens used in hygienic management. Developed by CEN and ISO, this European Standard ensures that products intended for contact lens disinfection are assessed using uniform procedures, thus enhancing the safety and efficacy of ophthalmic solutions in the management of contact lens hygiene.
The standard specifies two primary test methods to evaluate the antimicrobial effectiveness of both standalone products and comprehensive care regimens. By harmonizing test approaches, manufacturers, regulators, and laboratories can ensure comparable and reliable test results for contact lens disinfecting products and systems.
Key Topics
- Scope: Applies to all liquid chemical disinfecting products and regimens for contact lens care, excluding the management of trial lenses.
- Microbiological Performance Criteria: Establishes minimum requirements for reducing viable counts of bacteria, yeasts, and moulds during recommended soaking periods.
- Testing Protocols:
- Stand-alone Test: Evaluates individual product efficacy against specific challenge organisms.
- Regimen Test: Assesses a combination of products used as a system, simulating real-world usage scenarios.
- Quality Assurance: Maintains test reproducibility through detailed protocols, control procedures, and criteria for the use of specific microbial strains.
- Labeling: Stipulates when a product may be classified and labeled as a ‘disinfecting product’ versus part of a ‘disinfecting regimen’.
Applications
EN ISO 14729:2001 is a crucial tool for:
- Manufacturers of Contact Lens Solutions: Ensures products meet international safety and efficacy benchmarks before market entry.
- Testing Laboratories: Provides precise methodologies for microbiological evaluation, ensuring consistency in testing and validation across facilities.
- Regulators and Compliance Officers: Acts as a reference for market approval, certification, and post-market surveillance of contact lens disinfectants.
- Healthcare Providers and Eye Care Professionals: Offers confidence that recommended or prescribed contact lens care products are validated for antimicrobial performance.
- Consumers: Assures end-users that products labeled as effective for contact lens disinfection have undergone standardized, rigorous testing.
These applications contribute to reducing the risk of lens-associated ocular infections and support the safe, hygienic use of contact lenses worldwide.
Related Standards
EN ISO 14729:2001 references and complements several related standards, including:
- ISO 8320-1 & ISO 8320-2: Definitions and vocabulary for contact lenses and care products.
- General microbiological disinfectant standards (e.g., EN 1040, EN 1275): While relevant for other disinfectants, these do not address the unique requirements of contact lens care.
- Annexes within ISO 14729: Provide additional guidance on technical issues such as testing against viruses (Annex C), Acanthamoeba (Annex D), and procedures for membrane filtration (Annex B).
By adhering to EN ISO 14729:2001, stakeholders across the ophthalmic care sector can ensure high standards in microbial safety and efficacy for contact lens users, supporting public health and the integrity of the ophthalmic industry.
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Frequently Asked Questions
EN ISO 14729:2001 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001)". This standard covers: Specification of uniform test methods in order to achieve comparable test results.
Specification of uniform test methods in order to achieve comparable test results.
EN ISO 14729:2001 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 14729:2001 has the following relationships with other standards: It is inter standard links to CEN/TR 16227:2011, ISO 14729:2001, EN ISO 14729:2001/A1:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 14729:2001 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.KLJLHQVNHJDAugenoptik - Kontaktlinsenpflegemittel - Mikrobiologische Anforderungen und Prüfverfahren für Produkte und Systeme zum Hygienemanagement von Kontaktlinsen (ISO 14729:2001)Optique ophtalmique - Produits d'entretien des lentilles de contact - Exigences microbiologiques et méthodes d'essai des produits et protocoles d'entretien des lentilles de contact (ISO 14729:2001)Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 14729:2001SIST EN ISO 14729:2002en01-maj-2002SIST EN ISO 14729:2002SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14729April 2001ICS 11.040.70English versionOphthalmic optics - Contact lens care products - Microbiologicalrequirements and test methods for products and regimens forhygienic management of contact lenses (ISO 14729:2001)Optique ophtalmique - Produits d'entretien des lentilles decontact - Exigences microbiologiques et méthodes d'essaides produits et protocoles d'entretien des lentilles decontact (ISO 14729:2001)Augenoptik - Kontaktlinsenpflegemittel - MikrobiologischeAnforderungen und Prüfverfahren für 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/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 CEN 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 members 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14729:2001 ESIST EN ISO 14729:2002
Page 2EN ISO 14729:2001ForewordThe text of the International Standard ISO 14729:2001 has been prepared by 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 endorsement, 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, Belgium,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 any modification.SIST EN ISO 14729:2002
ReferencenumberISO14729:2001(E)©ISO2001INTERNATIONALSTANDARDISO14729Firstedition2001-04-15Ophthalmicoptics—Contactlenscareproducts—MicrobiologicalrequirementsandtestmethodsforproductsandregimensforhygienicmanagementofcontactlensesOptiqueophtalmique—Produitsd'entretiendeslentillesdecontact—Exigencesmicrobiologiquesetméthodesd'essaidesproduitsetprotocolesd'entretiendeslentillesdecontactSIST EN ISO 14729:2002
ISO14729:2001(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobe'slicensingpolicy.TheISOCentralSecretariatacceptsnoliabilityinthisarea.AdobeisatrademarkofAdobeSystemsIncorporated.DetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefile;thePDF-creationparameterswereoptimizedforprinting.EverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.©ISO2001Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56CH-1211Geneva20Tel.+41227490111Fax+41227490947E-mailcopyright@iso.chWebwww.iso.chPrintedinSwitzerlandii©ISO2001–AllrightsreservedSIST EN ISO 14729:2002
ISO14729:2001(E)©ISO2001–AllrightsreservediiiContentsPageForeword.ivIntroduction.v1Scope.12Normativereferences.13Termsanddefinitions.14Principle.24.1General.24.2Stand-alonetest(Inoculumchallengetest).24.3Regimentest.35Performancerequirements.35.1Stand-alonetest:Primarycriteria(seealsoTable1).35.2Stand-alonetest:Secondarycriteria(seealsoTable1).45.3Regimentest:Regimencriteria(seealsoTable1).46Testmethods.56.1Materialsandreagents.56.2Preparationofmicrobialchallenge(Inoculum).66.3Stand-aloneprocedure.76.4Regimenprocedure.10AnnexA(informative)Testorganismsfromotherculturecollections.13AnnexB(informative)Exampleofamembranefiltrationprocedure.14AnnexC(informative)Technicalreport:Virustesting.16AnnexD(informative)Technicalreport:Acanthamoebatesting.17AnnexE(informative)Technicalreport:Artificialtears(organicsoil)inlaboratorytesting.18Bibliography.19SIST EN ISO 14729:2002
ISO14729:2001(E)iv©ISO2001–AllrightsreservedForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.AttentionisdrawntothepossibilitythatsomeoftheelementsofthisInternationalStandardmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.InternationalStandardISO14729waspreparedbyTechnicalCommitteeISO/TC172,Opticsandopticalinstruments,SubcommitteeSC7,Ophthalmicopticsandinstruments.AnnexesAtoEofthisInternationalStandardareforinformationonly.SIST EN ISO 14729:2002
ISO14729:2001(E)©ISO2001–AllrightsreservedvIntroductionProductsforcontactlensdisinfectionbychemicalmeansareintendedtoreducemicrobialcontaminationintroducedduringlenswearandremoval,cleaningandstorageandarerequiredtocontainantimicrobialagentscapableofachievingthis.Itisessentialthatallliquidcontactlenscareproductsaresterileuntilopened.Dryproducts(tablets,granules,etc.)shouldbesubjecttocontrolofmicrobialcontaminationandshouldbedissolvedinasuitablediluentimmediatelypriortouse.Multidosecontactlenscareproductsmustbeadequatelypreservedorbepackagedinacontainerdesignedandlabelledtominimizetheriskofinjuryresultingfromin-usecontamination.Contactlensesarenormallysubjecttoaregimenofcleaningandcontactlensdisinfectionbetweenperiodsofwear.Aqueoussolutionscontainingcleaningand/ordisinfectingagentsarecommonlyusedforthispurpose.Theseproductsmaybemarketedassolutionsorastabletsfordissolutionimmediatelypriortouseinasuitablediluentsuchassaline.Thepast20yearsofexperienceintheuseandregulationofcontactlensdisinfectingproductshasshowndistinctdisinfectingantimicrobialcriteriaforthisclassofmedicaldevices.Oculartoxicologyconcerns,processconvenienceandproductcomfortontheeye,havemeantanevolutionofproductswhichmaintainalowincidenceofcontactlensassociatedocularinfectionwhenusedasinstructedbythemanufacturer.ThisInternationalStandardgivesthesedistinctcontactlensdisinfectingantimicrobialcriteriaalongwithannexestoexplainwhyviruses(annexC)andAcanthamoeba(annexD)arenotincludedaschallenges.Organicsoilisnotrequiredforevaluationofcontactlenscaredisinfectingproductsbutmaybeused;aninformativeannex(annexE)isincludedtodiscussorganicsoilinthecontextofcontactlensesandcontactlenscareproducts.SIST EN ISO 14729:2002
INTERNATIONALSTANDARDISO14729:2001(E)©ISO2001–Allrightsreserved1Ophthalmicoptics—Contactlenscareproducts—Microbiologicalrequirementsandtestmethodsforproductsandregimensforhygienicmanagementofcontactlenses1ScopeThisInternationalStandardspecifiestwotestmethodsforevaluatingtheantimicrobialactivityofproductstobemarketedforcontactlensdisinfectionbychemicalmeansandforproductsthatarepartofacontactlenscareregimen.ThisInternationalStandardisnotapplicabletothehygienicmanagementoftriallenses.NOTEGeneraldisinfectionproductstandardsarenotapplicabletocontactlenscareproducts,e.g.EN1040:1997andEN1275:1997.2NormativereferencesThefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO8320-1:—1),Contactlensesandcontactlenscareproducts—Vocabulary—Part1:Contactlenses.ISO8320-2:—1),Contactlensesandcontactlenscareproducts—Vocabulary—Part2:Contactlenscareproducts.3TermsanddefinitionsForthepurposesofthisInternationalStandard,thedefinitionsgiveninISO8320applytogetherwiththefollowing.3.1contactlensdisinfectingproductproductthatpossessescidalactivity(kills,destroysand/orinactivates)meetingtheprimarycriteriaofthestand-alonetestspecifiedinthisInternationalStandard3.2contactlensdisinfectingregimencontactlenscareregimendesignedtomeetboththesecondarycriteriaofthestand-alonetestandtheregimentestasspecifiedinthisInternationalStandard1)Tobepublished.(RevisionofISO8320:1986)SIST EN ISO 14729:2002
ISO14729:2001(E)2©ISO2001–Allrightsreserved3.3contactlensdisinfectionchemicalorphysicalprocesstoreducethenumberofviablemicroorganismsasspecifiedintheperformancerequirementsectionsofthisInternationalStandard4Principle4.1GeneralThestand-alonetestisdesignedtoqualifyindividualsolutionswithasuitablelevelofantimicrobialactivityascontactlensdisinfectionproducts.Theregimentestisdesignedtoqualifyindividualsolutionsaspartofacontactlensdisinfectingregimen.Productsmeetingtheregimentestcriteriashallalsomeettheminimumperformancerequirementsofthestand-alonetest.Itisfundamentalthatsuchproducts(unopenedcontainers)arecapableofmeetingtherequirementsofthetestthroughouttheirlabelledshelflife.AsdescribedinFigure1,contactlenscaresolutionswhicharedesignedtopossessdisinfectingpropertiesshallbetestedinthestand-alonetestfirst.Iftherespectiveprimarycriteriaaremet(see5.1),theproductmaybelabelledasacontactlensdisinfectingproduct.Iftheproductfailstheprimarycriteriaofthestand-alonetest,theproductmustexhibitsufficientantimicrobialactivitytomeetthesecondarycriteriaofthestand-alonetestaslistedin5.2.Ifthesesecondarycriteriaaremet,theregimentestshallbeperformedinordertoqualifytheproductaspartofacontactlensdisinfectingregimenbymeetingtheregimencriteria(see5.3).Iftheproductmeetsboththesecondarycriteriaofthestand-alonetestandtheregimentestbutfailstheprimarycriteriaofthestand-alonetest,itshallbelabelledaspartofacontactlensdisinfectingregimen.Thedesignofcontactlenscareproductsforcleaningandcontactlensdisinfectionshalltakeintoconsiderationtheneedsofpatientcomplianceandtheprobabilityofnon-compliance.Forexample,disinfectingtimemustbeappropriateforcontactlenswear.NOTEUseofmultipleormixedmicrobialchallengescaninfluencetheapparentdisinfectingactivityofaparticularproduct.TheevaluationofthesevariablestogetherwithtestingagainstalargerpanelofmicroorganismsandtestingofsamplesfrompartiallyusedcontainersmaybeofvalueindevelopingacontactlenscareproductbutareexcludedfromthescopeofthisInternationalStandard.(SeeannexesCandD).4.2Stand-alonetest(Inoculumchallengetest)Thestand-alonetestchallengesadisinfectingproductwithastandardinoculumofarepresentativerangeofmicroorganismsandestablishestheextentoftheirviabilitylossatpre-determinedtimeintervalscomparablewiththoseduringwhichtheproductmaybeused.Thesizeofthemicrobialchallengechoseninthistestisnotintendedtoberepresentativeofthelikelychallengeinpracticebuttoprovidecountablenumbersfromwhichestimationoftherateandextentofviabilitylosscanbedetermined.Incarryingoutthetestforantimicrobialactivitythequalitativeandquantitativecompositionsoftheproducthavetobeknownatthetimeoftestingbyeitheranalyticaltestingorextrapolation.Appropriatemeasuresshallbetakentoinactivateorremoveresidualantimicrobialagentsduringculturingandcountingofchallengeorganismsurvivors,andtheeffectivenessofthesemeasuresshallbevalidated.Theactionofthisprocessduringthetestshallbedemonstratedbytheconstructionofsuitablecontrols.NOTEForinformationaboutvirustesting,seeannexC,andforAcanthamoebatesting,seeannexD.SIST EN ISO 14729:2002
ISO14729:2001(E)©ISO2001–Allrightsreserved3aProductmaybelabelledasacontactlensdisinfectingproduct.bProductshallbelabelledaspartofacontactlensdisinfectingregimen.Figure1—Flowchartforstand-alonetestandregimentest4.3RegimentestThisisatestwhichchallengesamultifunctionaldisinfectingregimenwithastandardinoculumofarepresentativerangeofmicro-organismsandwhichmeasurestheviabilitylossafterapredeterminedtimeinterval;theinoculumiscarriedthroughtheregimenbybeingappliedtoacontactlens.Thisprocedureisapplicabletomultifunctionaldisinfectingregimenswhichmayincludethestepsofcleaning,rinsingandsoaking.Incarryingouttheregimentestprocedure,theproductsareusedinthemannerandquantityrecommendedinproductlabellingand/orpatientinstructions.Thedisinfectingstageofanyproposedcontactlensdisinfectingregimenevaluatedbythistestshallsatisfytheminimumrequirementsofthestand-alonetestasdescribedinFigure1.Onlythoseproductsthatsatisfytheminimumperformancerequirementsforthestand-alonetestmaybeincorporatedintoadisinfectingregimen.Incarryingoutthetest,qualitativeandquantitativecompositionofallproductsusedinthetestregimenhavetobeknownatthetimeoftesting,eitherbyanalyticaltestingorextrapolation.Appropriatemeasuresshallbetakentoinactivateorremoveresidualantimicrobialactivityduringculturingandcountingofchallengeorganismsurvivors,andtheeffectivenessofthesemeasuresshallbevalidated.Theactionofthisprocessduringthetestshallbedemonstratedbytheconstructionofsuitablecontrols.NOTEForproblemsassociatedwiththeuseofhuman-wornlenses,seeannexE.5Performancerequirements5.1Stand-alonetest:Primarycriteria(seealsoTable1)5.1.1BacteriaThenumberofeachchallengeorganismrecoveredpermillilitreshallbereducedbyanaveragevalueofnotlessthan99,9%(3,0logs)withintheminimumrecommendedsoakingperiod.SIST EN ISO 14729:2002
ISO14729:2001(E)4©ISO2001–AllrightsreservedNOTEThevalueisdeterminedbytakingtheaverageofthelogreductionsforeachchallengeorganismfortheindividuallotstested.5.1.2MouldsandyeastsThenumberofeachchallengeorganismrecoveredpermillilitreshallbereducedbyanaveragevalueofnotlessthan90%(1,0log)withintheminimumrecommendedsoakingperiodwithnoincreaseatnotlessthanfourtimestheminimumrecommendedsoakingperiodwithinanexperimentalerrorof0,5logs.NOTEThevalueisdeterminedbytakingtheaverageofthelogreductionsforeachchallengeorganismfortheindividuallotstested.5.2Stand-alonetest:Secondarycriteria(seealsoTable1)Productsfailingtomeetthecriteriain5.1.1or5.1.2shallbeevaluatedbytheregimentestproceduredescribedin6.4,providedthesumoftheaveragesisaminimumof5,0logunitsreductionforthethreespeciesofbacteriawithintherecommendedsoakingperiodwithaminimumaverageof1,0logunitreductionforanysinglebacteria.Stasisfortheyeastandmouldshallbeobservedfortherecommendedsoakingperiodwithinanexperimentalerrorof0,5logs.5.3Regimentest:Regimencriteria(seealsoTable1)Foreachmicrobialspecies,theaverageregimenrecoverycount(foralllotstested)shallbenomorethan10cfuforeachlenstype/storagesolutioncombination.Datafrommorethanonelenstypeshouldnotbecombinedtocalculatetheaverage.NOTEWhenqualifyingalenscareproductregimenforusewithonelenstype,theaveragecountforeachspeciesrequiresaveragingthedatafromthe24inoculatedandtreatedlensesoftheonelenstype.Whenqualifyingalenscareproductregimenforusewithmorethanonelenstype,theaveragecountforeachspeciesbylenstypewouldrequireaveragingthedatafromthe12inoculatedandtreatedlensesforeachlenstype.SeeTable4fornumbersoflensestobeused.SIST EN ISO 14729:2002
ISO14729:2001(E)©ISO2001–Allrightsreserved5Table1—SummaryofperformancerequirementscriteriaforcontactlensdisinfectionproceduresAveragelogreductionatsoakingtimeFungiBacteriaTestFSaCAaSMaPAaSAaStand-alonetest:PrimaryCriteria11333Stand-alonetest:SecondaryCriteriabbcccRegimentest:Regimencriteriad4to54to54to54to54to5aPA=P.aeruginosaATCC9027;SA=S.aureusATCC6538;SM=S.marcescensATCC13880;CA=C.albicansATCC10231;FS=F.solaniATCC36031.bStasisatthesoakingtime.cTheminimumacceptablelogreductionforallthreebacteriacombinedis5.Theminimumacceptablelogreductionforanysinglebacterialtypeis1.dEquivalenttoanaverageofnotmorethan10cfuperlenstype/storagesolutioncombination.6Testmethods6.1MaterialsandreagentsThematerialsandreagents(i.e.thetestorganisms,mediaandreagents,equipmentandsamples)arecommontoboththestand-aloneprocedurefordisinfectingproductsandtheregimenprocedureforcontactlensdisinfection.6.1.1TestorganismsThestrainslistedinTable2shallbeused.NOTETestorganismsfromotherculturecollectionsthatmaybeusedarelistedinannexA.Table2—TestorganismsPseudomonasaeruginosaATCC9027StaphylococcusaureusATCC6538SerratiamarcescensATCC13880CandidaalbicansATCC10231FusariumsolaniATCC360316.1.2Culturemediaandreagents6.1.2.1Potatodextroseagar(PDA).SIST EN ISO 14729:2002
ISO14729:2001(E)6©ISO2001–Allrightsreserved6.1.2.2Tryptonesoyaagar(TSA).6.1.2.3SabouraudDextroseAgar(SDA).6.1.2.4Dulbecco'sPhosphateBufferedSaline,withoutcalciumchlorideandmagnesiumchloride(DPBS):200mg/lKCl,200mg/lKH2PO4,8000mg/lNaCl,and2160mg/lNa2HPO47H2Oorsuitablediluent.6.1.2.5Dulbecco'sPhosphateBufferedSaline,plus0,05%(mass/volume)polysorbate80(DPBST)orsuitablediluent.6.1.2.6Validatedneutralizingagents/mediaasrequired,forexample,Dey-EngleyNeutralisingBroth(DEB)andLetheenBroth2).6.1.3TestequipmentThefollowingcommonlaboratoryequipmentisrequired.6.1.3.1Sterilepipettes.6.1.3.2Swabs.6.1.3.3Tubes.6.1.3.4Petridishes(90mmto100mm20mm).6.1.3.5Incubator.6.1.3.6Spectrometer,fordeterminationofcelldensity.6.1.3.7Instrumentforcolonycounting.6.1.3.8Centrifuge.6.1.4TestsamplesTheproducttobetestedshallberepresentativeoftheproducttobemarketed.Aliquotsshouldbetakendirectlyfromthefinalproductcontainerimmediatelypriortotesting.Threelotsofproductshallbetested.Eachlotofproductshallbetestedwithaseparateinoculumpreparationforeachchallengeorganism.6.1.5CulturemaintenanceMaintainthetestculturesasrecommendedbythecuratoroftheappropriateculturecollection.Culturesshouldbenogreaterthan5passesremovedfromthedepositorystock(ATCC,NCIB,NCTC,NCPForotherrecognizedculturedepository;seeannexA).Eachpassisasubcultureofthepreviouspass.6.2Preparationofmicrobialchallenge(Inoculum)Thepreparationofthemicrobialchallengeorganisms(inoculum)iscommontoboththestand-aloneprocedurefordisinfectingproductsandtheregimenprocedureforcontactlensdisinfection.2)Dey-EngleyNeutralisingBroth(DEB)andLetheenBrothareexamplesofsuitableproductsavailablecommercially.ThisinformationisgivenfortheconvenienceofusersofthisInternationalStandardanddoesnotconstituteanendorsementbyISOofthisproduct.SIST EN ISO 14729:2002
ISO14729:2001(E)©ISO2001–Allrightsreserved7Fortheregimenprocedureforcontactlensdisinfection,organicsoilmaybeincludedaspartoftheinoculum.SeeannexEforanexample.CultureeachtestorganismonagarslopesundertheconditionsgiveninTable3.Table3—MediaandincubationconditionsforgrowthofchallengeorganismsOrganismMediumTemperature°CIncubationtimeP.aeruginosaTSA30to3518hto24hS.aureusTSA30to3518hto24hS.marcescensTSA30to3518hto24hC.albicanxSDA20to2542hto48horC.albicansSDA30to3518hto24hF.solaniPDA20to2510dto14dUsesterileDPBSTorsuitablediluenttoharvesteachculture;washthesurfacegrowth,transferittoasuitablevesselandvortex.FiltertheF.solanisuspensionsthroughsterileglasswool,cheeseclothorgauzetoremovehyphalfragments.Afterharvesting,theculturedorganismsmaybewashedusingcentrifugation.Thebacterialsuspensionsmaybefiltered(e.g.3µmto5µmporesize)toproduceasinglecelldispersion.ThenadjustallchallengecellsuspensionswithDPBSTorothersuitablediluenttoaconcentrationofbetween1107cfu/mland1108cfu/ml.Estimatetheapproximatecellconcentrationofeachsuspensionbymeasuringtheturbidityofthesuspensionoradilutionofthesuspensionusingaspectrophotometer.Theactualconcentrationofcolonyformingunitspermillilitreshallbedeterminedforeachsuspension,e.g.bytheplatecountmethod,atthetimeofthetest.Ifacentrifugeisused,eachcentrifugationshouldbeconductedat20°Cto25°Cfornolongerthantheequivalentof10minat4000gorless.Longercentrifugationtimesmayberequiredatlowerspeeds.Usebacterialandyeastcellsuspensionsonthedayofpreparation.Sporesuspensionsmaybeuseduptosevendaysfollowingpreparationifstoredunderrefrigeration(2°Cto8°C).6.3Stand-aloneprocedure6.3.1Inoculumchallengetestprocedure6.3.1.1Prepareoneormoretubes(foreachlottested)containingaminimumof10mloftestproductsolutionperchallengeorganism.NOTESampletubesareusedratherthanlenscasestoalloweffectivetechnicalexecutionofthetest.Sinceincompatibilitiescanexistbetweensolutioningredientsandtubematerials,tubesofanappropriatematerial,whicharecompatiblewiththeingredients,shouldbeused.Inoculatethesampletubeoftheproducttobetestedwithasuspensionoftestorganismssufficienttoprovideafinalcountofbetween1,0105and1,0106cfu/ml.Ensurethatthevolumeofinoculumdoesnotexceed1%ofthesamplevolume.Ensurecompletedispersionoftheinoculumbyadequatemixing.6.3.1.2Storetheinoculatedproductat20°Cto25°C.Thetemperatureshallbemonitoredusingacalibrateddeviceandthetemperaturedocumented.Iftheproductissensitivetolightitshouldbeprotectedduringtheperiodofthetest.SIST EN ISO 14729:2002
ISO14729:2001(E)8©ISO2001–Allrightsreserved6.3.1.3Take1,0mlaliquotsoftheinoculatedproductfordeterminationofviablecountat25%,50%,75%and100%oftheminimumrecommendeddisinfectingtimeforallorganisms,and,inaddition,notlessthan400%oftheminimumrecommendeddisinfectingtimeforyeastandmould.Ifovernightcontactlensdisinfectionisrecommended,useasoakingtimeof8h.6.3.1.4Subjecteachofthe1,0mlaliquots,removedatthespecifiedtimeintervals,toasuitableseriesofdecimaldilutionsinvalidatedneutralizingmedia.Mixthesuspensionwellbyvortexingvigorouslyandletstandtoallowneutralizationtobecompleted.Neutralizationconditionsshallbebasedonrecoverymediumcontroltesting(see6.3.2.2).Ifanantimicrobialagentintheformulationcannotbeadequatelyinactivatedorneutralized,eliminateitusingavalidatedmembranefiltrationprocedure(seeannexB).6.3.1.5Determinetheviablecountoforganismsinappropriatedilutionsbypreparationoftriplicateplates(unlessotherwisejustified)ofasuitablerecoverymedium(e.g.TSAforbacteriaandSDAformouldandyeast).Ifmembranefiltrationhasbeenemployedtoremoveorneutralizeantimicrobialagents,culturethemembranesonthesemediaasappropriate.Ifthepourplatemethodisutilized,keeptheagarforpourplatesbelow50Cpriortopouring.Theagarmediausedfordeterminationofviablecountsmayalsocontainantimicrobialinactivatorsorneutralizers,ifrequired.6.3.1.6Incubatebacterialrecoveryplatesat30Cto35C.Incubateyeastrecoveryplatesat20Cto25Cor30Cto35C.Incubatemouldrecoveryplatesat20Cto25C.Incubationtimesforoptimalrecoveryofbacteria,yeastandmouldsshallbedetermined.Minimumincubationtimesshallbebasedonrecoverymediumcontroltesting(see6.3.2).Recordthenumberofcfuobservedoncountableplates.NOTEPlatesshouldbeobservedperiodicallyduringincubationtopreventtheoccurrenceofuncountableplatesduetoovergrowth.6.3.1.7Determinetheaveragenumberofcolonyformingunitsoncountableplates.Calculatethemicrobialreductionatthespecifiedtimepoints.NOTECountableplatesreferto30cfu/plateto300cfu/plateforbacteriaandyeast,and8cfu/plateto80cfu/plateformoulds,exceptwhencoloniesareobservedonlyforthe100or10-1dilutionplates.6.3.1.8Theabsenceofmicroorganismsshallbedocumented,e.g.byrecordingan"0”or"NR”(norecovery),whenplatesforalldilutionsofasampleatasingletimepointhavezerocolonies.6.3.2Controls6.3.2.1InoculumControlPrepareaninoculumcountbydispersinganidenticalaliquotoftheinoculumintothesamevolumeasusedin6.3.1.1ofasuitablediluent(e.g.DPBST)toachieveafinalconcentrationof1,0105cfu/mlto1,0106cfu/ml.Ensurethatthevolumeofinoculumdoesnotexceed1%ofthesamp
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