ISO 03533-2021.docx

INTERNATIONA1.STANDARDISO3533editionFirst2021-09SextoysDesignandsafetyrequirementsforproductsindirectcontactwithgenita1.ia,theanus,orbothSextoysExigencesre1.ativesaIaconceptionetaIasecuritedesProdUitSdestinesaetremisencontactdirectavecIesorganesgnitaux,anusouIesdeux©ISO2021COPYRIGHTPROTECTEDDOCUMENT©ISO2021岫rkdea/山thUcdOthcnviscjft<c三orrtmcehDVBiwixuioiti08phnn11UatiocBhr<1.>hotoc<>p)Mng,ptbcatonpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanherequestedfromeitherISOattheaddressbe1.oworIS<smemberbodyinthecountryoftherequester.%,tft晒Iandonnet8CH-1214*crnicr,GenevaPhone：M1.22749O1.11Pub1.ishedinSwitzerhndContentsPageForewordivIntroductionv2 Scope13 Normativereferences14 Termsanddefinitions1Genera1.requirementsforriskmanagement一.24.1 Genera)24.2 Riskana1.ysisprocess21.-5Designrequirements35.1.1 Ana1.useproducts.35.29hanica1.Prtant8iofretention5.2.2 Productsforgenita1.enc1.osure.45.2.3 Movingandremovab1.eparts41.4 E1.ectrica1.safety5.4.1E1.ectrica1.stimu1.ation1.5 Surfacetemperature56 R1.ater1.a1.S56.1 Genera1.562Mater1.a1.Safety.57 USerInfOrmat1.On67.1 Genera1.67.2 Contentofuserinformationonproduct67.5 Rddi丽闻userinformation<Annex A (informative)Guidanceonriskmanagement8Annex B (informative)Designconsiderationsbasedonanatomy.11Annex C (informative)GuidanceforcreatingaRestrictedSubstance1.ist14Bib1.iography15ForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsttiugh(ISOmrtm匕山biftbni)r盟RAucekdWpnf1.QbbGgbodyICmitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceare崛则搬OfISO1.ECdj三-翩山糖n°tW三W蝴er%COrdanCethecdito11a1.ru1.esoftheISO/IECDirectives,Part2(seewww.iso.org/dnc1.iivcs).Rf三ionri颜sd隘丽n隔嗯解8股ns冲¥神出飘游做孤而出doc1.1.瞅棉犯鼠邯监ssubjectofanypatentrightsidentifiedduringthedeve1.opmerUMe4ow1.wU-w4JbeintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(seewww.iso.org/pa1.ents).Anytradeusedinthisconstitutenameendorsement,documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand哪蝴蜘明瓶ationc。的福P奥爽隈两,the喂济IIi潴相柝猫EM池微件筋0taM4isoforeword.htn1.移遂禺姆初?由褪粉蜩阮幽)1制HsME8/?(做凄咐O/PC325,SexToys-DesignandsafetyrequirementsAnyfeedbackorquestionsonthisdocumentshou1.dbedirectedtotheuser,snationa1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundatwww.iso.org/members.htm1.SextoysDesignandsafetyrequirementsforproductsindirectcontactwithgenita1.ia,theanus,orboth1 Scopeformanufacturedproductsintendedforsexua1.use.assistivedocumentisnotprimari1.y1.ubricants,massageproductsc1.assifiedasmedica1.devices,cosmeticsor2 Normativereferencesconstitutesrequirements1.atesteditiondocument.referencedreferences,(inc1.udingamendments)app1.ies.app1.ies.ISOTermsanddefinitions5(e(yco1.oursandsafetysignsRegisteredsafetysignsForthepurposesofthisdocument,thefo1.1.owingtermsanddefinitionsapp1.y.ISOOn1.inebrowsingp1.atform:avai1.ab1.eathttps/WWv.isc：OFgbp3.1sextoy1.ubricants,massagcExdudcd:productsgc1.sspraysrandmCdica1.supp1.cmcntsxosmeticsorassistiveproducts;forexamp1.e,3.2intendeduseSOURCE:ISO14971:2019,3.6modified,processandservicede1.eted,a1.ternativetermde1.etedriskSOURCE:ISO/IECGuide51:2014,3.9J©ISO2021-A1.1.rightsreservedThisdocumentspecifiessafetyanduserinformationrequirementsre1.atingtothemateria1.sanddesignThisdocumentcoverson1.ymanufacturedproductsthatareintendedtocomeindirectcontactwithgenita1.sand/ortheanus.Thisproductsforexamp1.eintendedforoi1.Thefo1.1.owingdomentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentundatedreferences,theofthisoftheFordateddocumenton1.ytheanyeditioncitedForISO7000,GrQphicaIsymboIsforuseonequipmentRegisteredsymbo1.s37010,Graphica1.symbo1.sISOandIECmaintaintermino1.ogydatabasesforuseinstandardizationa1.thefo1.1.owingaddresses：IECE1.ectropedia:avai1.ab1.eathttps:/www.e1.ectropedia.org/manufacturedproductintendedforsexua1.stimu1.ationortoenhancesexua1.p1.easureNote1coentry：oi1.,intimateCIasSifiedasfooddevices.useforwhichaproductisintendedaccordingtothespecifications,inst11ctions,andinformationprovidedbythemanufacturer(3.4)3.3 combinationoftheprobabi1.ityofoccurrenceofharmandtheseverityofthatharm3.4manufacturernatura1.or1.ega1.personwhomanufacturesorfu1.1.yrefurbishesadeviceorhasadevicedesigned,manufactured,orft1.1.yrefurbished,andmarketsthatdeviceunderitsnameortrademarkNotiei<entUgatghttei.PoMbi1.itjessube<1.htrd<foeportMfcetiw>1.n<attor.responsibi1.itiesOfthemanufacturer.甥C2toentry:Importingaproductconstitutesthesame1.ega1.responsibi1.ityasofamanufacturer.sharpedgeaccessib1.eedgeofaSeXtoy(3.1)whichpresentsanunreasonab1.eriskofinjuryduringintendeduse(3.2)andreasonab1.yforeseeab1.emisuse(3.6)FgURCEUSO8124-1:2018,3.33modified,sextoy,intendedandmisuseupdated,hazardousde1.etedreasonab1.yforeseeab1.emisuseuseofaproductinawaynotintendedbythemanufacturer(3.4)butwhichcanresu1.tfromreadi1.ypredictab1.ehumanbehaviourNote1toentry:Reasonab1.yforeseeab1.emisusecanbeintentiona1.orunintentiona1.SOURCE:ISO14971:2019,3.15modified,systemde1.eted,note1toentryde1.etedforeseeab1.euseuseofaproductthatisCaPabIeofbeingknownoranticipatedinadvancebasedonamanufacturer's(3.4)bestknow1.edgeabouttheproduct4S(fiff型11TfiW汪gW累由H曲愀m/Itchangedtomanufacturer's4.1 Genera1.Thesafetyoftheproductsha1.1.beassessedbasedonariskana1.ysisidentifyingpotentia1.risksassociatedwiththeintendeduseoftheproduct,fromthedesignphaseunti1.disposa1.oftheproduct.Theriskana1.ysisprocesssha1.1.inc1.ude: Riskassessment Documentationoftheriskassessment Periodica1.review Postmarketcontro1.tM6Y由Iia1.ysisan通SiSPrOCeSSdeSCribedinAnnexA.琳goingmdMf三痈rer的抽防删限ha碑决Ument,aMia蔺ain渊1Woughou曲由mat础rod1.曲舞陶西ingtheassociatedrisks,contro1.1.ingtheserisks,andmonitoringtheeffectivenessoftheriskcontro1.sinthepost-marketphase.ear1.ymanagementpotentia1.risksassociatedbcwiththetheproduct,managementsystem,reasonab1.y4.3 RiskassessmenthazardousAsituation,estimationassociatedperfbrmedSha1.1.eachhazardoussituationidenti11ed.infrtnationOridentifiedactivitiessha1.1.bedocumented.Themanufacturersha1.1.ensurethatthepersonorteamperformingtheriskassessmentarecompetent4.4 Post-marketcontro1.manufacturertoconductfie1.dcorrectiveactionsproductionindividua1.post-marketbatches,ifrequired.enab1.esthefurthcDesignrequirementsre1.a1.ingto,forexamp1.emateria1.anddesignsafety.5.1 Genera1.Inforniation.Designinc1.udesa1.1.aspectsoftheproductinc1.uding,shape,size,materia1.s,packaging,anduser5.1.1 Ana1.useproductscana1.physio1.ogyofminimized.Theysha1.1.rectum.designedAnnexconsiderationsbasedonthenorma1.anatomyNOTEcannotInbcgraspedWithcxpcrtisvorinstrumentsgenera1.1.yUscdobjcctsorproducts,Commonproccdurcs.isthat5.2 Mechanica1.hazards5.2.1 Preventionofretentiondescribedinurethra.BThisSha1.1.appropriatemeansTnitigationappropriaterreferencestore1.evantc1.inica1.Ariskdetectionofandana1.ysisprocesscanpartofqua1.ityitsintendeduseandThisforeseeab1.emisuse.Themanufacturersha1.1.documentanyknownorforeseeab1.ehazards,ormisuseassociatedwithsextoy.risktherisk(三)forbeestimatedusingavai1.ab1.eForeachdata.Forhazardoussituationsforwhichtheprobabi1.ityoftheoccurrenceofharmcannotbeestimated,thepossib1.econsequencessha1.1.be1.istedforuseinriskeva1.uationandriskcontro1.Theresu1.toftheseEachriskeva1.uationsha1.1.bereviewedperiodica1.1.y,basedonuserfeedback,post-marketsurvei1.1.anceandnewscientific1.iterature.Anymodificationorchangetothepmductrequiresanewriskeva1.uation.todoso.Themanufacturersha1.1.estab1.ish,document,andmaintainasystemtoco1.1.ectandperiodica1.1.yreviewinfo11nationaboutthesextoyinthetheproductionphases.ThisContinuousassessmentofproductsafetycanbedoneviacustomerfeedback.Thedatacanbeusedto5improvetheproducts.A1.1.productssha1.1.bedesignedbasedontheintendeduse.Asanintegratedpartofthedesignprocess,requirementspecificationsandriskassessmentproceduressha1.1.beconductedtopreventanyharm.NOTEProductsusedonorintheanus,sha1.1.bedesignedsothattheriskofretainingtheproductintheana1.andorrectumisthehumananusandbeSeewithBforguidance.Iftheproductisinsertedintotheanus,methodsofsafe1.yextractingitbytheuseristobepreferredovermethodsrequiringmedica1.expertise.theycasemedica1.fingersisneededtoextractretainedforana1.recta1.medica1.prob1.emManufacturerssha1.1.conductariskassessment,inc1.udingconsideringanatomica1.designconsiderationrectum,orAnnex,tofindbeconfirmedbyofusingrasoftheriskofretentionthevagina,anus,and/orscientific1.iteratureinadditiontorequirementsinthisdocument.5.2.1.1 Ana1.useproductsAsextoysha1.1.haveSUnidentmechanismsanddesignfeaturestopreventthemfrombeinginsertedt娴也dddajmftutresfcttidn1.dEreictwmdMiiIgi世外QKtbiiityinUmddddn>ductThethebase-to-neckratioshou1.dbeconsidered.EXAMPLE 1 Ana1.p1.ugs,ana1.beads,ana1.di1.dos.Mediumand1.argeproductssha1.1.havedesignfeaturesmakingitpossib1.eformedica1.professiona1.stoextractifretained,byusingtoo1.sandinstrumentscommon1.yusedformedica1.procedures.SeeTab1.eB.2.EXAMPLE 2 1.oops,strings,Oraccessib1.eedges.5.2.1.2 Non-ana1.useproductsSextoysnotintendedforana1.use,butwhichcanbemisusedassuch,sha1.1.havec1.earinformationintheuserinformationoftheintendedpurposeandhownottousetheproduct.Manufacturersshou1.dconsideraddingdesignfeaturesmakingretrieva1.possib1.eforforeseeab1.eana1.retention.5.2.2 Productsforgenita1.enc1.osuresextoyintendedforenc1.osinggenita1.sforexamp1.e,peni1.erigidityring,chastitydevices,etc.,sha1.1.bmefdtRj11mgab1.e(1.rdhess)stt1.tfegentthhaonst11ied11chjsiBpa11sfeiMtd1.rowateOTitewt'rth?commonhouseho1.dtoo1.ssuchasp1.iers.Theysha1.1.notrequiretheuseofpowertoo1.sforremova1.5.2.3 Movingandremovab1.epartsIftheproductisdesignedwithremovab1.epartswhichmayposeariskwhennotproper1.yfixeditsha1.1.whenaun1.ocked.mechanismwhichensuresthatthepartsstayinp1.aceduringuseandareon1.yre1.easedSX3MP1.EVibrationmachinewithrep1.aceab1.edi1.dos,batterycompartments.Hazardstotheuserfromvibrationsha1.1.beassessedintheriskana1.ysis.Manufacturerssha1.1.eva1.uateanyvibrationfrompoweredsextoysintheintendedenvironment(三)ofuse.durationPOWerUdproductssha1.1.inc1.udeanautomatictime1.imitorc1.ear1.ystatemaximumtimeofJE5349-2,Jpg9rerscanconsiderstandardsre1.atingtotheeffectsofvibration,forexamp1.eISO5349-1,5.4E1.ectrica1.safetyThemanufacturersha1.1.considerthee1.ectrica1.safetyoftheproductduringthedesignphase,basedonintendeduseandreasonab1.yforeseeab1.emisuse.Thisinc1.udesthechargerandchargingoftheproduct5.4.1 E1.ectrica1.stimu1.ationProductsintendedtostimu1.ategenita1.sviae1.ectricimpu1.sessha1.1.beriskassessedbyqua1.ifiedthirdpartyanddeemedsafetouse.S1.S-ESurf412iUik1.bft1.tyreanbeacertified1.aboratory.Ii冢胭由0dw1.hwithsu的的屈。熟er&iK?Mh呻睡na1.她H1叫研ROntaCthazar®曲MRyH三iytheduringtheintendeduse.Themaximumsurfacetemperatureshou1.dnotexceed41andsha1.1.neverexceed48.NOTEISO13732-1statesthresho1.dsforburn.Theheatinge1.ementsha1.1.bedesignedsoitautomatica1.1.yturnsoffbeforethetemperatureofthesurfaceexceeds48,takingintoaccounttemperatureinertia.PhMiUCtmgiatort1.iedtteHOUIdtaeM1.tinafro购UXternai螭SOnab1.eambienttemperatureupto30andifthe5.6Designrequirementforwire1.essremote-contro1.1.edproductsForanyremote-contro1.1.edproduct,theunitthatisintouchwiththebodysha1.1.haveac1.earandsimp1.e5¾,toSrfa(CsQcorners,edges,andprotrudingpartswithgenita1.ia,theanus,intendedfunctionsmoothPrOdUCt,freeaccessib1.epartsintendedtobeinContaetNOTESeeISO8124-1:2018,4.6,4.7,5,8,59E.1.1.forinformation.6Materia1.s6.1 Genera1.Manufacturersshou1.dconsiderenvironmenta1.aspectsofmateria1.susedandproductionmethodswithoutcompromisingtheuser'ssafety.6.2 Materia1.safety3ittNW1.wWdMfSha1.1.makesurethatnochemica1.sinquantitiesknowntobeharmfu1.fortheuserareThemanufacturersha1.1.estab1.ishaRestrictedSubstance1.ist(RS1.)inc1.uding1.imitsofsubstancesthatsha1.1.notbepresentinthemateria1.sthatcomeintocontactWithmucosa.Themanufacturershou1.destab1.ish,imp1.ement,andmaintainaproceduretoidentifytheapp1.icab1.e1.awsandregu1.ationsofthecountrieswheretheproductsaremanufactured,imported,distributedandso1.d,inordertoensurethatapp1.icab1.e1.ega1.requirementsaretakenintoaccount.SeennexCforguidanceoncreatingaRestrictedSubstance1.ist.A1.1.materia1.safetyinformationsha1.1.hemadeavai1.ab1.eduringaprocurementprocess.6.3 Bioconipatibi1.itySextoysareproductswithrepeatedcontactWithmucosaandpossib1.ycompromisedtissue,sha1.1.Manufac1.urersbiocornpatib1.e.makesurethatthemateria1.s,thatcomeintocontactwithmucosaduringintendedForsextoys,on1.yinvitromethodssha1.1.beused.Dtntest1fereti吊算e<0i醛蝴'三iiin和3鹿斓觥飘锄丽品SareTWUei阳屏Qxa+»能,se姓视WaycanISO10993seriesareISO10993-5,ISO10993-10AnnexCi),andISO10993-23C1.ause6.Anotherwaycanbetouseon1.ymateria1.s,inc1.udingadditivesandco1.ouringhavebeentestedaccordingtothatseriesorfoodcontactapproved.Testingsha1.1.bedonebyanaccredited1.aboratory.The1.aboratorysha1.1.conformwiththerequirementsinISO/IEC17025.Theresu1.tssha1.1.beinterpretedbyatoxico1.ogistoranotherqua1.ifiedexpert6.4 C1.eaningandmaintenanceThemanufacturersha1.1.infnntheuseraboutc1.eaningmethodsandmeansforthespecificproducts,in牙CuSejn1.4"enorjmatihintendeduse.7.1Genera1.Userinformationsha1.1.inc1.udea1.1.informationdirectedtotheconsumer.productthesesha1.1.beincorrespondencewithMarketinginformationsha1.1.heconsistentwithproductinformation.Thedistributorshou1.densurethattheconsumerinformationisavai1.ab1.eina1.anguageunderstoodbytheusers.7.2 ContentofuserinformationonproductInformationontheproductsha1.1.inc1.ude:C1.earindicationonhowtoturntheproductonandoff,ife1.ectrica1.1.ypowered1.ot,batch,orseria1.number,asfaraspossib1.e,orifthisisnotpossib1.eitsha1.1.beontheproductpackage7.3 PackagingInformationontheproductpackagingsha1.1.at1.eastinc1.ude: Descriptionofprc1.uctfunctiona1.ityandintendeduse Specificationofmateria1.intendedtobeincontactwithgenita1.ia,anus/rectum,orboth Stateorusesymbo1."Containsnatura1.rubber1.atex'*(ifapp1.icab1.e) Informationaboutbatteryand/orcharging(ifapp1.icab1.e) InfciTnationOnWhatisinc1.udedorneededitemswhichareexc1.uded1)Underpreparation.Stageatthetimeofpub1.ication：)SOFDIS10993-10.6EXAMP1.E1Battery,ad叩ter,chargingequ