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Withdrawn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
30-Apr-1999
Withdrawal Date
14-May-2011
ICS
11.040.70 - Ophthalmic equipment
Technical Committee
CEN/TC 170 - Ophthalmic optics
Drafting Committee
CEN/TC 170 - Ophthalmic optics
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-May-2011
Completion Date
15-May-2011
Ref Project
SIST EN ISO 13212:2000 - Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)

Relations

Replaced By
EN ISO 13212:2011 - Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2011)
Effective Date
08-Jun-2022
Referred By
EN ISO 9455-17:2006 - Soft soldering fluxes - Test methods - Part 17: Surface insulation resistance comb test and electrochemical migration test of flux residues (ISO 9455-17:2002)
Effective Date
28-Jan-2026
Referred By
EN 81-31:2010 - Safety rules for the construction and installation of lifts - Lifts for the transport of goods only - Part 31: Accessible goods only lifts
Effective Date
28-Jan-2026

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Frequently Asked Questions

EN ISO 13212:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)". This standard covers: Migrated from Progress Sheet (TC Comment) (2000-07-10): Will go to a second // enquiry (ZM 971205).

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

EN ISO 13212:1999 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 13212:1999 has the following relationships with other standards: It is inter standard links to EN ISO 13212:2011, EN ISO 9455-17:2006, EN 81-31:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 13212:1999 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.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
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

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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