SIST EN 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 a 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• Status: Withdrawn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: 31-Oct-2000
• Withdrawal Date: 02-Dec-2014
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 03-Dec-2014
• Due Date: 26-Dec-2014
• Completion Date: 03-Dec-2014
• Ref Project: EN ISO 11978:2000 - Ophtalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000)

Relations

• Replaced By: SIST EN ISO 11978:2015 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2014)
• Effective Date: 01-Jan-2015

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



SIST EN ISO 11978:2000



SIST EN ISO 11978:2000



SIST EN ISO 11978:2000



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.ISOcopyrightofficeCasepostal[e-mail]©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



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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