EN ISO 13212:1999
(Main)Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life (ISO 13212:1999)
General Information
- Abstract
Migrated from Progress Sheet (TC Comment) (2000-07-10): Will go to a second // enquiry (ZM 971205).
- Status
- Withdrawn
- Publication Date
- 30-Apr-1999
- Withdrawal Date
- 14-May-2011
- 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
Relations
- Effective Date
- 08-Jun-2022
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Consolidated By
ISO 13212:1999 - Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life - Effective Date
- 12-Feb-2026
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
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, ISO 13212:1999. 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
...