SIST EN ISO 13212:2000

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• Status: Withdrawn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
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Jun-2011
• Due Date: 24-Jun-2011
• Completion Date: 02-Jun-2011
• Ref Project: EN ISO 13212:1999 - Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)

Relations

• Replaced By: SIST EN ISO 13212:2011 - Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2011)
• Effective Date: 01-Jul-2011
• Replaced By: SIST EN ISO 13212:2011 - Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2011)
• Effective Date: 08-Jun-2022

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-1211Genè[e-mail]ForewordISO(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
...