Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Will go to a second // enquiry (ZM 971205).

Augenoptik - Kontaktlinsenpflegemittel - Leitfaden für die Bestimmung der Lagerdauer (ISO 13212:1999)

Diese internationale Norm gibt einen Leitfaden für die Auslegung von Stabilitätsuntersuchungen mit dem Ziel, Informationen betreffend die Bestimmung der Lagerdauer zusammenzutragen, an. Sie gilt nicht für mikrobiologische Gesichtspunkte im Hinblick auf Informationen zur Vernichtung (en: discard statement).

Optique ophtalmique - Produits d'entretien pour lentilles de contact - Lignes directrices pour la détermination de la détermination de la durée de conservation (ISO 13212:1999)

Očesna optika - Izdelki za vzdrževanje kontaktnih leč - Smernice za določevanje roka uporabnosti (ISO 13212:1999)

General Information

Status
Withdrawn
Publication Date
31-Dec-1999
Withdrawal Date
01-Jun-2011
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Jun-2011
Due Date
24-Jun-2011
Completion Date
02-Jun-2011

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EN ISO 13212:2000
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Kontaktlinsenpflegemittel - Leitfaden für die Bestimmung der Lagerdauer (ISO 13212:1999)Optique ophtalmique - Produits d'entretien pour lentilles de contact - Lignes directrices pour la détermination de la détermination de la durée de conservation (ISO 13212:1999)Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 13212:1999SIST EN ISO 13212:2000en01-januar-2000SIST EN ISO 13212:2000SLOVENSKI
STANDARD



SIST EN ISO 13212:2000



SIST EN ISO 13212:2000



SIST EN ISO 13212:2000



SIST EN ISO 13212:2000



SIST EN ISO 13212:2000



ReferencenumberISO13212:1999(E)INTERNATIONALSTANDARDISO13212Firstedition1999-05-01Correctedandreprinted1999-12-01Ophthalmicoptics—Contactlenscareproducts—Guidelinesfordeterminationofshelf-lifeOptiqueopthalmique—Produitsd'entretienpourlentillesdecontact—LignesdirectricespourladéterminationdeladuréedeconservationSIST EN ISO 13212:2000



ISO13212:1999(E)©ISO1999Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromthepublisher.InternationalOrganizationforStandardizationCasepostale56CH-1211Genève20SwitzerlandInternetiso@iso.chPrintedinSwitzerlandiiForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.InternationalStandardISO13212waspreparedbyTechnicalCommitteeISO/TC172,Opticsandopticalinstruments,SubcommitteeSC7,Ophthalmicopticsandinstruments.AnnexAofthisInternationalStandardisforinformationonly.SIST EN ISO 13212:2000



©ISOISO13212:1999(E)iiiIntroductionThepurposeofstabilitytestsofcontactlenscareproductsistoobtainsufficientinformationtoenablethemanufacturertoestablishanappropriateshelf-lifeandidentifyanyuniquestorageconditionsrequiredtoappearonthelabellingfortheproduct.Thequalityofacontactlenscareproductisdeterminedbyitscontentofactiveingredient(s),itspurityanditsphysicochemicalandmicrobiologicalproperties.Dueaccountshouldbetakenofpossibleinteractionofthecontainer/closurewiththecontents.Thestabilitystudiesshouldascertainhowthequalityofaproductvariesasafunctionoftimeandundertheinfluenceofavarietyofenvironmentalfactors.Onthebasisoftheinformationthusobtained,storageconditionsarerecommendedwhichwillguaranteemaintenanceofthequalityoftheproduct,inrelationtoitssafety,performanceandacceptability,throughouttheproposedshelf-life.Thedesignofthefinished-productstabilitystudiesforacontactlenscareproductisbasedonknowledgeobtainedfromstudiesontheactiveingredient(s)andfromthedevelopmentstudies.SIST EN ISO 13212:2000



SIST EN ISO 13212:2000



INTERNATIONALSTANDARD©ISOISO13212:1999(E)1Ophthalmicoptics—Contactlenscareproducts—Guidelinesfordeterminationofshelf-life1ScopeThisInternationalStandardprovidesguidanceonthedesignofstabilitystudiestouseingatheringinformationtoallowdeterminationofshelf-lifeofcontactlenscareproducts.ThisInternationalStandarddoesnotaddressstudiesdesignedtoobtaininformationtoestablishthein-usestability(i.e.discardstatement)ofcontactlenscareproducts.2NormativereferencesThefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO8320-1,Contactlensesandcontactlenscareproducts—Vocabulary—Part1:Contactlenses.ISO8320-2,Contactlensesandcontactlenscareproducts—Vocabulary—Part2:Contactlenscareproducts.ISO14534:1997,Ophthalmicoptics—Contactlensesandcontactlenscareproducts—Fundamentalrequirements.ISO147291),Ophthalmicoptics—Contactlenscareproducts—Microbiologicalrequirementsforproductsandregimensforhygienicmanagementofcontactlenses.ISO147301),Ophthalmicoptics—Contactlensesandcontactlenscareproducts—Antimicrobialpreservativeefficacytestinganddiscarddatingofmulti-dosepreservedcontactlenscareproducts.3TermsanddefinitionsForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO8320-1andISO8320-2apply.1)Tobepublished.SIST EN ISO 13212:2000



ISO13212:1999(E)©ISO24Requirements4.1Thespecifiedshelf-lifeofthecontactlenscareproductshallbebasedontheevaluationoftheresultsofstabilitystudies.4.2Analyticalmethodsthathavebeenvalidatedandarestability-indicatingshallbeusedtoassayforactiveingredients.Validationincludes,butisnotlimitedto,beingabletodifferentiatebetweentheactiveingredientanditsdegradationproducts.Thetestmethodsusedshallbefullydescribed.5Determinationoffinishedproductstability5.1ObjectiveTheobjectiveofstabilitytestingoncontactlenscareproductsistoprovidedatafordeterminingthetimeperiodduringwhichtheproductperformancecharacteristicsaremaintainedandtodefineappropriatestorageconditions.Thedesignofthestabilitytestsisbasedontheknownpropertiesoftheactiveingredient(s),thepropertiesofthechosenformulationandrecommendationforuseoftheproduct.Therelevantassaymethodsshallbedeterminedpriortothestartofthestabilitytesting.Thespecificationsproposedatthetimeofmanufactureandvalidtotheendoftheproposedshelf-lifeshallreflect,asfaraspossible,theresultsofthestabilitystudies,particularlyinrelationtoanyparameterswhichcouldhaveabearingonperformanceandsafetyandproductacceptability.5.2Studymethods5.2.1GeneralBeforestartingstabilitystudies,asuitabletestingplanshouldbesetup,takingintoconsiderationthepropertiesoftheactiveingredient(s)aswellastheproposedmodeofactionofthecareproduct.5.2.2Real-timestudiesThesestudiesshouldbecarriedoutunderarangeofcontrolledtestconditions,whenapplicable,whichwillenabletheshelf-lifeandtheproductcontainerlabel/packageinsertstoragerequirementstobedefined.Thiswillnormallyincludestudieswhichshouldallowthepropertiesoftheproductattemperaturesbetween20°Cand30°Ctobeevaluated.However,25°C+2°Cshouldbeusedasthemeankinetictestingtemperature.Foreachstudy,themeantemperature,therangesoftemperatureandthemeanhumidity,ifapplicable,shallbestatedinthestabilityreport.Thesestudiesareintendedtosupporttheinitialshelf-liferequestand,forshelf-lifeextensions,anychangesthatcouldsignificantlyimpactthesafetyandperformanceoftheproduct(e.g.certainchangesinformulation,packagingmaterialsormanufacturingmethods).NOTEReal-timestudiesshouldbeperformedinconjunctionwithacceleratedageingstudiestoestablishaninitialshelf-life.5.2.3StudiesundervaryingstorageconditionsThesestudiesshallbecarriedouttoprovideimportantadditionalinformation.Theycanfulfilanumberofobjectives,suchas:tosupporttheinitialshelf-liferequestbycomplementingthelimitedresultsofearlyreal-timestudies,asdecomposition,ifitisoccurring,islikelytobeaccelerated;SIST EN ISO 13212:2000



©ISOISO13212:1999(E)3toproduceusefuldataatanearlystageofdevelopment,todemonstratetheeffectsofadversestorageinthepackagingandproduct,andtoenablestorageconditionsandsuitablelabellingtobeprovided;tosupportarequesttoextendtheshelf-life.Thevarioustestconditionsshouldbestated.Dependingonthenatureandobjectivesofthestabilitystudy,thefollowingmayneed
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