SIST EN ISO 13212:2000
(Main)Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)
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)
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Standards Content (Sample)
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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