ASTM F963-2011最新完整版(9)

ASTM F963-2011 新版

(b)Themigrationofelementsfromtoysandpartsoftoysasspeci edin4.3.5.2(1)shallnotexceedthelimitsspeci edinTable1whentestedinaccordancewiththemethodssetforthin8.3.Modelingclaysincludedaspartofatoyshallnotexceedthelimitsspeci edinTable2whentestedinaccordancewiththemethodssetforthin8.3.PleasenotethatthelimitsinTable2applyonlytothesematerialsasacomponentofatoy;inaddition,pleasealsonotethatiftheprimarypurposeofthematerialistocreateatangibleworkofart,itmayinadditionbesubjecttotherequirementsof16CFR1500.14.

(c)Inaddition,metallictoysormetallictoycomponentswhicharesmallpartsmaynotexhibitextractionofmorethan200µgofcadmiumwhentestedper8.3.5.5(3).Compliancewithalloftheaboverequirementsmaybeestablishedbyascreenoftotalelementcontentasspeci edin8.3.1.

4.3.6Cosmetics,Liquids,Pastes,Putties,Gels,andPowders—Thepurposeofthisrequirementistominimizetheriskassociatedwiththelackofcleanliness,shelflife,andcontaminationofcosmetics,liquids,pastes,putties,gels,andpowdersusedintoys(excludingartmaterials).Itsetsstandardsforcleanlinessandtheabilitytowithstandextendedshelflifeorcontamination,orboth,duringusewithoutmicrobiologicaldegradation.

4.3.6.1Waterusedinthemanufacturingand llingoftoysshallbepreparedaccordingtothebacteriologicalstandardsforUSPPuri edWater.(Warning—Thevariousmethodsforproducingpuri edwatereachpresentdifferentpotentialsforcontaminatingthe nalproduct.Puri edwaterproducedbydistillationissterile,providedthattheproductionequipmentissuitableandsterile.Ontheotherhand,ion-exchangecolumnsandreverseosmosisunitsrequirespecialattentioninthattheyaffordsitesformicroorganismstofoulthesystemandcon-taminatetheeffluent.Frequentmonitoringmaythusbecalledfor,particularlywiththeuseoftheseunitsfollowingperiodsofshutdownofmorethanafewhours.)

4.3.6.2Theformulationsoftheseproductsusedintoysshallbesuchthattheyarenotsubjecttomicrobialdegradationduringshelflifeorreasonablyforeseeableuse.

4.3.6.3Thecleanlinessoftheseproductsusedintoysandtheiringredientsshallbedeterminedinaccordancewith8.4.1.Formulationsusedtopreventmicrobialdegradationshallbeevaluatedinaccordancewith8.4.2.

4.3.6.4Formulationsofcosmeticsshallbeevaluatedforpotentialmicrobiologicaldegradationinaccordancewith8.4.2.4.3.7Stuff ngMaterials—Loose llersforstuffedtoysshallbefreeofobjectionablematteroriginatingfrominsect,bird,rodent,orotheranimalinfestationandofcontaminants,suchassplintersandmetalchipstotheextentpossibleingoodmanufacturingpractice.ThetestmethodsthatshallbeusedtodetermineobjectionablematerialareinChapter16ofOff cialMethodsofAnalysisoftheAssociationofOff cialAnalytical

thecontainedsolids(includingpigments, lmsolids,anddriers)giveninTable1.Theanalyticalresultsobtainedshouldbeadjustedinaccordancewiththetestmethodin8.3.4.3priortocomparingthemtothevaluesinTable1.Todetermineconformance,thesolublelevelshallbedeterminedbydissolv-ingthecontainedsolids(dried lmincludingpigments, lmsolids,anddriers)asspeci edin8.3.2.

4.3.5.2ToySubstrateMaterials—Theserequirementsaredesignedtoreducechildren’sexposuretoheavyelementscontainedinaccessibletoysubstratematerials.(Forrequire-mentsforsurfacecoatingmaterials,see4.3.5.1.)

(1)Scope—Thissectionspeci esrequirementsandtestmethodsfortotalleadandthemigrationofantimony,arsenic,lead,barium,cadmium,chromium,mercuryandseleniuminaccessiblesubstratematerials.Accessibleglass,metalandceramictoysorpartsoftoys,thataresmallparts(thatis,that tintothetest xturespeci edat16CFR1501(seeFig.3),arealsosubjecttothisrequirement.

(a)Accessibilityofpartsshallbedeterminedasde nedin3.1.2beforeandafteruseandabusetestingdescribedin8.4-8.9.

(b)Toysandpartsoftoyswhich,duetotheirinaccessibility,size,mass,function,orothercharacteristics,cannotbesucked,mouthedoringestedarenotsubjecttothisrequirement.

NOTE3—Forthepurposesofthisrequirement,thefollowingcriteriaareconsideredreasonablyappropriatefortheclassi cationoftoysorpartslikelytobesucked,mouthedoringested:(1)Alltoypartsintendedtobemouthedorcontactfoodordrink,componentsoftoyswhicharecosmetics,andcomponentsofwritinginstrumentscategorizedastoys;(2)Toysintendedforchildrenlessthan6yearsofage,thatis,allaccessiblepartsandcomponentswherethereisaprobabilitythatthosepartsandcomponentsmaycomeintocontactwiththemouth.

(c)Packagingmaterialsarenotsubjecttotheserequirementsunlesstheyareintendedtoberetainedaspartofthetoyorareintendedtoprovideplayvalue.

(d)Thisrequirementisnotintendedtoapplytochildren’sjewelry,whichisaddressedbySpeci cationF2923.

(e)Inaddition,materialsnoworinfuturelistedinthemostcurrentrevisionof16CFR1500.88or16CFR1500.91asexemptfromtestingandcerti cationrequirementsareex-cludedfromthisrequirementforthepurposesofdeterminingcompliance.

(2)Requirements:

(a)Accessiblecomponentpartsofchildren’sproducts(asde nedin3.1.2andin16CFR1500.87,beforeandafteruseandabusetestingdescribedin8.4-8.9andin16CFR1500.50-53and16CFR1500.87)mustnotcontainleadorleadcompoundsinwhichtheleadcontent(calculatedasleadmetal[Pb])isinexcessof100ppm(300ppmforproductsmanu-facturedorimportedpriortoAugust14,2011)oftheweightofthecomponent,exceptasprovidedunder16CFR1500.88and16CFR1500.91.

TABLE1MaximumSolubleMigratedElementinppm(mg/kg)forSurfaceCoatingsandSubstratesOtherThanModelingClay

IncludedasPartofaToy

Antimony,Arsenic,Barium,Cadmium,Chromium,Lead,Mercury,Selenium,(Sb)(As)(Ba)(Cd)(Cr)(Pb)(Hg)(Se)6025100075609060500

TABLE2MaximumSolubleMigratedElementinppm(mg/kg)for

ModelingClaysIncludedasPartofaToy

Antimony,Arsenic,Barium,Cadmium,Chromium,Lead,Mercury,Selenium,(Sb)(As)(Ba)(Cd)(Cr)(Pb)(Hg)(Se)602525050259025

500