EN ISO 11978:2000
(Main)Ophtalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000)
Ophtalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen (ISO 11978:2000)
Diese Internationale Norm legt fest, welche Informationen der Hersteller von Kontaktlinsen und Kontaktlinsenpflegemitteln zur Verfügung stellen muß, um den richtigen und sicheren Gebrauch dieser Produkte und ihres Zubehörs durch beide Arten von Anwendern von Kontaktlinsen - den Kontaktlinsenanpasser und den Kontaktlinsenträger - sicherzustellen. Diese Internationale Norm legt nicht fest, in welcher Form diese Informationen zur Verfügung zu stellen sind.
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Informations à fournir par le fabricant (ISO 11978:2000)
La présente Norme internationale spécifie les informations à fournir par le fabricant de lentilles de contact et de leurs produits d'entretien, afin de garantir une utilisation correcte et sans danger de ces dispositifs et de leurs accessoires par les deux types d'utilisateur des lentilles de contact : l'adaptateur et le porteur de lentilles.La présente Norme internationale ne spécifie pas le support de présentation de ces informations.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Informacije proizvajalca (ISO 11978:2000)
General Information
- Status
- Withdrawn
- Publication Date
- 14-Mar-2000
- Withdrawal Date
- 20-Jan-2026
- Technical Committee
- CEN/TC 170 - Ophthalmic optics
- Drafting Committee
- CEN/TC 170 - Ophthalmic optics
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Oct-2014
- Completion Date
- 21-Jan-2026
Relations
- Effective Date
- 22-Oct-2014
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Frequently Asked Questions
EN ISO 11978:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophtalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000)". This standard covers: Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage
EN ISO 11978:2000 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 11978:2000 has the following relationships with other standards: It is inter standard links to EN ISO 11978:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 11978:2000 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 - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen (ISO 11978:2000)Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Informations a fournir par le fabricant (ISO 11978:2000)Ophtalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 11978:2000SIST EN ISO 11978:2000en01-november-2000SIST EN ISO 11978:2000SLOVENSKI
STANDARD
ReferencenumberISO11978:2000(E)©ISO2000INTERNATIONALSTANDARDISO11978Firstedition2000-03-15Ophthalmicoptics—Contactlensesandcontactlenscareproducts—InformationsuppliedbythemanufacturerOptiqueophtalmique—Lentillesdecontactetproduitsd'entretiendeslentillesdecontact—InformationsàfournirparlefabricantSIST EN ISO 11978:2000
ISO11978:2000(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobe'slicensingpolicy.TheISOCentralSecretariatacceptsnoliabilityinthisarea.AdobeisatrademarkofAdobeSystemsIncorporated.DetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefile;thePDF-creationparameterswereoptimizedforprinting.EverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.©ISO2000Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56CH-1211Geneva20Tel.+41227490111Fax+41227341079E-mailcopyright@iso.chWebwww.iso.chPrintedinSwitzerlandii©ISO2000–AllrightsreservedSIST EN ISO 11978:2000
ISO11978:2000(E)©ISO2000–AllrightsreservediiiContentsPageForeword.ivIntroduction.v1Scope.12Normativereferences.13Termsanddefinitions.14Contactlensinformationsuppliedbythemanufacturer.24.1General.24.2Label.24.3Instructionsforuse.35Contactlenscareproductinformationsuppliedbythemanufacturer.45.1General.45.2Label.45.3Instructionsforuse.6Bibliography.7SIST EN ISO 11978:2000
ISO11978:2000(E)iv©ISO2000–AllrightsreservedForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.AttentionisdrawntothepossibilitythatsomeoftheelementsofthisInternationalStandardmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.InternationalStandardISO11978waspreparedbyTechnicalCommitteeISO/TC172,Opticsandopticalinstruments,SubcommitteeSC7,Ophthalmicopticsandinstruments.SIST EN ISO 11978:2000
ISO11978:2000(E)©ISO2000–AllrightsreservedvIntroductionThisInternationalStandardattemptstoharmonizerequirements,wheneverpossible,forlabellingofcontactlensesandcontactlenscareproductswithnationallaws,regulationsorguidelinesthatmayexistincountriesthroughouttheworld.Wherenationallawsandlabellingrequirementsexistincountriesformedicaldevices,theyareoftendevelopedbylegislativebodiesorregulatoryauthoritiesindependentlyfromthedevelopmentprocessforInternationalStandards.Therefore,labellingrequirementsestablishedbyanindividualcountrycannotalwaysbereadilyintegratedintoInternationalStandards.TheinformationgiveninthisInternationalStandardprovidesasuitableframeworkfordevelopinglabellingforcontactlensesandcontactlenscareproducts.Conformancetotheelementshereinshouldbesufficientfordevelopingappropriatelabellingforcountrieswithoutexistinglawsorregulationsformedicaldevicelabelling.However,conformancewiththeelementsofthisInternationalStandardmaynotbesufficientforfullcompliancewithadditionallabellingrequirementsmandatedbyanindividualcountry.WherenationallawsorregulationsmandateadditionallabellingrequirementsorconflictwithelementsofthisInternationalStandard,thenationallaworregulationshouldbefollowedandshouldtakeprecedenceovertheelementsofthisvoluntaryInternationalStandard.Manufacturersshouldfamiliarizethemselveswiththelabellingrequirements,ifany,ofthecountrieschosenformarketingoftheirproducts.Failuretocomplywithlabellingrequirementsofaspecificcountrycouldresultinseriousconsequencesforamanufacturerthatcouldotherwisehavebeenavoided.ConformancewiththeelementsofthisInternationalStandardshouldminimize,butmaynotnecessarilyeliminate,therisksfordevelopinglabellingthatcouldseriouslyviolateorconflictwithspecificrequirementsmandatedbythelawsandregulationsofanindividualcountry.SIST EN ISO 11978:2000
INTERNATIONALSTANDARDISO11978:2000(E)©ISO2000–Allrightsreserved1Ophthalmicoptics—Contactlensesandcontactlenscareproducts—Informationsuppliedbythemanufacturer1ScopeThisInternationalStandardspecifiestheinformationtobeprovidedbythemanufacturerofcontactlensesandcontactlenscareproductstoensurethecorrectandsafeuseofthesedevicesandtheiraccessoriesbybothtypesofuserofcontactlenses:theeyecareprofessionalandthecontactlenswearer.ThisInternationalStandarddoesnotspecifytheformatinwhichsuchinformationshallbeprovided.2NormativereferencesThefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO8320-1:—1),Contactlensesandcontactlenscareproducts—Vocabulary—Part1:Contactlenses.ISO8320-2:—1),Contactlensesandcontactlenscareproducts—Vocabulary—Part2:Contactlenscareproducts.3TermsanddefinitionsForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO8320-1andISO8320-2andthefollowingapply.3.1contactlenscareproductcontactlensaccessoryintendedforuseinmaintainingthesafetyandperformanceofacontactlensafteropeningandremovalofthecontactlensfromitsoriginalshippingpackageNOTEThisdefinitionincludesalldevicesrecommendedforuseinthemanagementofcontactlenshygiene,forhydratingcontactlenses,orforalleviatingdiscomfortofcontactlenswearbyphysicalmeans.[ISO14534:1997]3.2manufacturernaturalorlegalpersonwithresponsibilityforthedesign,manufacture,packagingandlabellingofamedicaldevicebeforeitisplacedonthemarketonhisownbehalf,regardlessofwhethertheseoperationsarecarriedoutbythatpersonhimselforonhisbehalfbyathirdparty1)Tobepublished.SIST EN ISO 11978:2000
ISO11978:2000(E)2©ISO2000–Allrightsreserved3.3informationsuppliedbythemanufacturerdetailsonthelabelandintheinstr
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