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    眼视光产品 元件安全技术规范(外文版)(报批稿).docx

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    眼视光产品 元件安全技术规范(外文版)(报批稿).docx

    1、ICS11.040.70CCSY89G日NationalStandardsofthePeoplesRepiblicofChinaGB451842024Optometryproducts一SafetytechnicaIspecificationsofcomponents眼视光产品元件安全技术规范Issuedate:2024-12-31ImpIementationdate:2026-01-01ContentsForeword111 Scope12 Normativereferences13 Termsanddefinitions13.1 14 SafetytechnicaIrequirements

    2、44.1 GeneraI44.2 OpticaIrequirements44.3 Transmittanceproperty74.4 MechanicaIstrength94.5 Resistancetoperspiration94.6 MechanicaIstabiIity94.7 NickeIreIease105 Testmethods105.1 1Testconditions105.2 OpticaIrequirements115.3 Transmittancerequirements175.4 MechanicaIstrength205.5 Resistancetoperspirati

    3、on225.6 BridgedeformationandIensretention225.7 NickeIreIease24AnnexA(informative)Resistancetoperspirationequipment25ForewordSACTC596SC1isinchargeofthisEnglishtransIation.IncaseofanydoubtaboutthecontentsofthisEngIishtransIation,theChineseoriginalversionshalIbeconsideredauthoritative.Thisdocumentisdra

    4、ftedinaccordancewiththeruIesgivenintheGB/T1.12020DirectivesforStandardization-Part1:Rulesforthestructureanddraftingofstandardizingdocuments.AttentionisdrawntothepossibiIitythatsomeoftheeIementsofthisdocumentmaybethesubjectofpatentrights.TheissuingbodyofthisdocumentshalInotbeheIdresponsibIeforidentif

    5、yinganyoralIsuchpatentrights.ThisdocumentwasproposedandpreparedbyMinistryofIndustryandInformationTechnoIogyofthePeopIesRepubIicofChina.:specificationsofOptometryproducts一SafetytechnicaIcomponents1 ScopeThisdocumentdefinesthetermsanddefinitions,specifiesrequirements,anddescribesthecorrespondingtestme

    6、thodsforcomponents.ThisdocumentisappIicabIetocomponents.2 NormativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralIoftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onIytheeditioncitedappIies.Forundatedreferences,theIatesteditionofthereferenceddocumen

    7、t(includinganyamedments)appIies.GB/T6682WaterforanalyticallaboratoryuseSpecificationandtestmethodsGB/T26397Ophthalmicoptics一TerminologyGB/T38009Spectacleframes-RequiremetandmethodforthedetectionofnickelreleaseISO13666:2019Ophthalmicoptics-SpectaclelensesVocabulary3 TermsanddefinitionsForthepurposeof

    8、thisdocument,thetermsanddefinitionsgiveninGB/T26397andISO13666andthefollowingappIy.3.1finishedspectacIesvarioustypesofspectacIeswhicharereadyforuse.Note:TypesgeneraIIyrefertoordinaryspectacIes,partiaIIyorfullyencIosedgoggIes,fIip-upordetachabIeadditionaIIenses,etc.CommonexampIesoffinishedspectacIesi

    9、ncIudeprescriptionassembIedspectacIes,near-visionspectacIes,sunglasses,surfaceswimminggoggIes,snowgoggles,spectacIesforvehicIedrivingandroaduse,poIarized3Dglasses,etc.3.2componentsThemainpartsofthefinishedspectacIes.Note:ForexampIe,finishedlensesandframes.3.3focaIpowerGeneraItermcomprisingthespheric

    10、aIandcyIindricaIvertexpowersofaIens.3.4dioptricpowerGeneraItermcomprisingthefocaIpowerandtheprismaticpowerofaIens.3.5vertexpowerReciprocaIoftheparaxiaIvertexfocaIIength.Note:AccordingtotheophthaImicconvention,the“powerofaIensisspecifiedasthebackvertexpower.DioptresareexpressedinreciprocaImetres(m1).

    11、CommonIyusedsymbolsfordioptreareDanddpt,(1D=1m1).3.6PrismaticpowerTheprismaticeffectoftheIensreferencepoint.Note:CommonIyusedsymboIsorabbreviationsfortheprismdioptreareandcmm.3.7variationpowerpower-variationIensdifferencebetweenthevertexpowersatthesecondaryreferencepointandtheprimaryreferencepoint,o

    12、rbetweendistancereferencepointandnearreferencepoint.Note1:Variationpowerisdefinedforpower-variationIensesonlyiftheyhavebothaprimaryandasecondaryreferencepoint.Note2:ForthemultifocaIIenses,thevariationpowerisadditionpower,whichisthedifferencebetweenthedistancereferencepointandnearreferencepointonthep

    13、rescribedconditions.Note3:NominaIarithmeticvaIueofthedesignednegativepowerchangeofadegressive-powerIensfromthenearzonetotheupperpartoftheIens.SOURCE:ISO13666:2019,3.16.4,modified3.8referencepointstipulatedbythemanufacturer,onthefrontsurfaceofafinishedIensoronthefinishedsurfaceofabIankatwhichtheverif

    14、icationpowerofaspecificportionappIiesSOURCE:ISO13666:2019,3.2.19,modified3.9distancereferencepoint,majorreferencepointPointonthefrontsurfaceoftheIensatwhichtheverificationpowerforthedistanceportionappIies.SOURCE:ISO13666:2019,3.2.20,modified3.10nearreferencepointPointonthefrontsurfaceoftheIensatwhic

    15、htheverificationpowerforthenearportionappIies.SOURCE:ISO13666:2019,3.2.21,modified3.11PrimaryreferencepointPointonthefrontsurfaceofapower-variationIensatwhichtheverificationpowerforthedesignedprimaryuseoftheIensappliesNOTE:AlIpower-variationlenseshaveaprimaryreferencepoint.SOURCE:ISO13666:2019,3.2.2

    16、2,modified3.12secondaryreferencepointpointonthefrontsurfaceofapower-variationIensatwhichtheverificationpowerforthedesignedsecondaryuseoftheIensappliesNote:Somepower-variationIensescanhaveasecondaryreferencepointthatisusedforthedeterminationofvariationpower.SOURCE:ISO13666:2019,3.2.23,modified3.13sin

    17、gIe-visionIensAIensdesignedtoprovideasingledioptricpowerSOURCE:ISO13666:2019,3.7.13. 14position-specificsingIe-visionIenssingIe-visionIens,generaIIywithcompIexsurfacegeometry,thatneedstobepositionedaccurateIyaccordingtotheorderedspecificationandbearspermanentaIignmentreferencemarkings.Note:Single-vi

    18、sionIensescaIcuIatedtotakeintoaccounttheas-wornpositionandthereforerequiringaccuratemountinginfrontofthewearer,seye.SOURCE:ISO13666:2019,3.7.2,modified3.15aIignmentreferencemarkingPermanentmarkingsareprovidedbythemanufacturertoestabIishthehorizontaIaIignmentoftheIensorbIank,ortore-estabIishtherefere

    19、ncepoints.SOURCE:ISO13666:2019,3.15.253.16multifocaIIensLensdesignedtoprovidetwoormorevisiblydividedportionsofdifferentfocaIpowers.SOURCE:ISO13666:2019,3.7.34. 17power-variationIensSpectacIeIenswithasmoothvariationoffocaIpoweroverpartoralIofitsarea,withoutdiscontinuity,designedtoprovidemorethanonefo

    20、caIpower.Note1:TheseareusuaIIydesignedtoprovideincreasingordecreasingsphericaIpower,typicaIIyinaverticaImeridian,soastocorrectdifferentobjectdistances.Note2:ExampIesofpower-variationIensesare,butnotIimitedto,progressive-powerIensesanddegressive-powerIenses.SOURCE:ISO13666:2019,3.7.75. 18progressive-

    21、powerIens,progressive-additionIens,varifocaIIensPower-variationIenswithtworeferencepointsforfocaIpower,generaIIydesignedtoprovidecorrectionforpresbyopiaandclearvisionfromdistancetonearNote:Progressive-powerIenseshaveaprimaryreferencepointthatisthedistancereferencepointandasecondaryreferencepointthat

    22、isthenearreferencepoint.SOURCE:ISO13666:2019,3.7.8,modified6. 19degressive-powerIensPower-variationIenswithaprimaryreferencepointfornearvision,generaIIydesignedtoprovidecIearvisionfromneartofurtherdistances.Note:degressive-powerlenseshaveaprimaryreferencepointthatisthenearreferencepointandasecondary

    23、referencepointthatisthedistancereferencepoint.SOURCE:ISO13666:2019,3.7.9,modified7. 20sungIarefiIter,sungIassfiIterFiIterintendedtoreducesoIargIareandtoreducesoIaruItravioIetradiationtoasafeIeveI.8. 21pIanosungIarefiIter,pIanosungIassfilterSunglarefiIterwithoutintendedvertexpower.9. SafetytechnicaIr

    24、equirements9.1 GeneraITheopticaIcharacteristicsshaIIbeverifiedusingafoeimeteroritsequivaIent.TheopticaIparametersforuncutfinishedIensesshaIIbeappIiedatthedesignreferencepointunlessspecifiedotherwise.Ifthemanufacturerstatesaverificationpower,thentherangesandtoIerancesinTabIe1toTabIe5shaIIbechosenacco

    25、rdingtotheverificationpower.Inthiscase,theverificationpowermaybestatedbythemanufactureronthepackageorinanaccompanyingdocument.9.2 OpticaIrequirements4.2.1Vertexpower4.2.1.1Accordingtothemethoddescribedin5.2.1,spectacIeIensesshaIIcompIywiththedeviationonthepowerofeachprincipalmeridianandthecyIindrica

    26、Ipower,seeTabIe1orTable2.TabIe1TolerancesonthevertexpowerofsingIe-visionandmultifocaIIensesValuesinreciprocalmetreAbsoIutevaIueofvertexpoweronthemeridianpIanewiththeIargestabsolutevaIueofvertexpowerToleranceonthevertexpowerrofeachprincipalmerdianVaIueofcyIindrcaIvertexpower0.000.750.754.004.006.006.

    27、00ToleranceontheabsoIutecyIindricaIvertexpower0.003.000.120.090.120.18一3.006.000.120.120.120.180.256.009.000.120.120.180.180.259.0012.000.180.120.180.250.2512.0020.000.250.180.250.250.2520.000.370.250.250.370.37TabIe2ToIerancesonthevertexpowerofpower-variationIensesVaIuesinreciprocaImetreAbsolutevaI

    28、ueofvertexpoweronthemeridianpIanewiththeIargestabsolutevaIueofvertexpowerToleranceonthevertexpowerrofeachprincipalmerdianVaIueofcyIindrcaIvertexpower0.000.750.754.004.006.006.00ToleranceontheabsoIutecyIindricaIvertexpower0.006.000.120.120.180.180.256.009.000.180.180.180.180.259.0012.000.180.180.180.

    29、250.2512.0020.000.250.180.250.250.2520.000.370.250.250.370.374.2.1.2Accordingtothemethoddescribedin5.2.1,thesphericaIpowerandastigmaticpowerofpIanosungIarefiItersshaIInotexceedthetoIerancesgiveninTabIe3.TabIe3TolerancesonsphericaIandastigmaticpowerValuesinreciprocaImetreSphericaIpowerAstigmaticpower

    30、meanvaIueofvertexpoweroftwoprincipalmeridians.(Pl+Z2)2absoIutevaIueofvertexpowerdifferencebetweentwoprincipalmeridiansIp-I0.120.124.2.2DirectionofthecyIinderaxisDirectionofthecyIinderaxisisonIyappIicabIetotomultifocaIIenses,singIe-visionIenseswithapredeterminedorientation,andpower-variationlenses.Ac

    31、cordingtothemethoddescribedin5.2.2,thedirectionofthecylinderaxisshaIIcompIywiththetolerancesspecifiedinTabIe4.TabIe4ToIerancesonthedirectionofthecyIinderaxisAbsoIutevaIueofcyIindricaIvertexpowerm10.250.500.500.750.751.501.50ToleranceonthedirectionofthecyIinderaxisdegrees(o)/1475324.2.3 Variationpowe

    32、rAccordingtothemethoddescribedin5.2.3,thevariationpowerofmultifocaIIensesandpower-variationIensesshaIIcompIywiththetoIerancesspecifiedinTabIe5.TabIe5TolerancesonthevariationpowerVaIuesinreciprocaImetreVaIueofthevariationpower(includingadditionpower)4.004.00Tolerance0.120.184.2.4 Prismaticpower4.2.4.

    33、1Accordingtothemethoddescribedin5.2.4,thetotaIprism(includingorderedandthicknessreductionprism)shaIIcompIywiththetoIerancesgiveninTable6.TabIe6PrismatictoIeranceVaIuesinprismdioptresPrismatictoIerancevaIueSingle-visionMultifocaIandposition-specificsingIe-visionandpower-variationIenseshorizontaIcompo

    34、nentverticaIcomponent0.002.00(0.25+0.1XSJ(0.25+0.15L)(0.25+0.05XlSL)2.0010.00(0.37+0.1XSJ(0.37+0.1XSJ(0.37+0.05XSJ10.00(0.50+0.1X鼠.)(0.50+0.15L)(0.50+0.055rax)Note1:SlaXisthefocaIpower,inthemeridianofhigherabsoluteprincipalpower.Note2:(0.1XtsIaX)correspondstotheprismaticeffectof0.1cmdispIacement,whi

    35、le(0.05X鼠x)correspondstotheprismaticeffectof0.05cmdispIacement.4.2.4.2Accordingtothemethoddescribedin5.2.4,theprismaticpowerofpIanosungIarefiItersshalInotexceed0.25cmm.4.3Transmittanceproperty4.3.1. TransmittanceandUVtransmittanceproperty4.3.2. 1Accordingtothemethoddescribedin5.3,spectacIeIensesandp

    36、IanosungIarefiItersshaIImeettherequirementsofcategoriesinTabIe7.TabIe7TransmittancecategoriesCategoryVisiblespectraIrangeUltravioletspectraIrangeRangeofIuminoustransmittanceTVMaximumvaIueofUV-AtransmittanceSUVAMaximumvaIueofUV-BtransmittanceSUVB315nm380nm280nm315nm080.0%100.0%TV0.05TV143.0%80.0%TV0.

    37、05TV218.0%43.0%0.5TV1.0%absoIuteor0.05rvwhicheverisgreater38.0%18.0%0.5TV1.0%absolute43.0%8.0%1.0%absoIuteor0.25rvwhicheverisgreater1.0%absoluteNote:ExceptforcoIourIessglasslenseswithnoexpressedUVproperties.4.3.3. 1.2Accordingtothemethoddescribedin5.3,theIensesshaIIbefoIIowedas.uniformlytintedIenses

    38、incategory03shaIIhaveaIuminoustransmittancethatshaIInotIieoutsidetheIimitsofthestatedcategorybymorethan2%absolute;incategory4shaIIhaveaIuminoustransmittancethatshaIInotIieoutsidetheIimitsofthatIuminoustransmittance.gradient-tintedlenses,inthatshaIInotIieoutsidecategorybymorethan20%reIativetothestat

    39、edcategory03shalIhaveaIuminoustransmittancetheIimitsofthestatedcategorybymorethan4%absoIute;incategory4shaIIhaveaIuminoustransmittancethatshalInotIieoutsidetheIimitsofthatcategorybymorethan40%Iuminoustransmittance.foraIensnominatedbythemanufacturerashavingavaIue,theIimitsoftheIuminoustransmittancesh

    40、aII4.3.1.3Accordingtothemethoddescribedin5.3,thepIanofoIIowedas:reIativetothestatedIuminoustransmittancenotmoresunglarethan8%.fiItersshaIIbeuniformlytintedIenses,incategory03shaIIhaveaIuminoustransmittancethatshaIInotIieoutsidetheIimitsofthestatedcategorybymorethan2%absoIute;gradient-tintedIenses,in

    41、category03shalIhaveaIuminoustransmittancethatshaIInotIieoutsidetheIimitsofthestatedcategorybymorethan4%absolute;themaximumdeviationofthedecIaredIuminoustransmittancevaIue,shaIIbe3%absoIute,forthetransmittancevaIuesfallingincategories03,and30%reIativeforthetransmittancevaIuesfallingincategory4.4.3.2U

    42、niformityofIuminoustransmittanceAccordingtothemethoddescribedin5.3.4,TheuniformityofIuminoustransmittance(f)ofpIanosunglarefiItersshaIIbeasfoIIows:a) category0-3:f10%;b) category4:f20%.ForunmountedfiIterscoveringbotheyes,thereIativedifferencebetweentheIuminoustransmittancevaIueofthefiItersattherefer

    43、encepointfortherightandlefteyesshaIInotexceed15%foraIIothertypes.Note:ChangesofIuminoustransmittancethatarecausedbythicknessvariationsduetothedesignofthefiIterarepermitted.4.3.3Wide-anglescatterAccordingtothemethoddescribedin5.3.5,theHazevaIuesofpIanosunglarefiItersshalInotbemorethan3%.4.3.4Requirem

    44、entsforroaduseanddriving4.3.4.1DayIightuseAccordingtothemethoddescribedin5.3.2,theIuminoustransmittanceofspectacIeIenses,j,shaIIbenotIessthan8%.4.3.4.2DrivingintwiIightoratnightAccordingtothemethoddescribedin5.3.2,IuminoustransmittanceofspectacIeIenses,j,shaIIbenotIessthan75%.4.3.4.3SpectraItransmit

    45、tanceAccordingtothemethoddescribedin5.3.2,ThespectraItransmittanceofspectacIeIenses,atanywaveIengthintherange475nmto650nmshalIbenotIessthan0.204.3.4.4DetectionoftrafficsignaIIightAccordingtothemethoddescribedin5.3.2,relativevisuaIattenuationCOeffiCient(OofspectacIeIenses,shaIIbefoIIowedas:red0.80;ye

    46、Ilow0.60;green0.60;bIue0.40.Accordingtothemethoddescribedin5.3.2,reIativevisuaIattenuationcoefficient(ofpIanosungIarefilters,shaIIbefollowedas:red0.80;yeIlow0.60;green0.60;blue0.60.4.4 MechanicaIstrengthAccordingtothemethoddescribedin5.4,thefollowingdefectsshaIInotbeapparent:a) Iensfracture:AspectacIeIensshaIIbeconsideredtohavefracturedifithascrackedthroughitsentirethicknessintotwoormorepiecesorifmorethan5mgoftheIensmateriaIhasbecomedetachedfromthesurface


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