1、INTERNATIONA1.STANDARDISO3533editionFirst2021-09SextoysDesignandsafetyrequirementsforproductsindirectcontactwithgenita1.ia,theanus,orbothSextoysExigencesre1.ativesaIaconceptionetaIasecuritedesProdUitSdestinesaetremisencontactdirectavecIesorganesgnitaux,anusouIesdeuxISO2021COPYRIGHTPROTECTEDDOCUMENTI
2、SO2021岫rkdea/山thUcdOthcnviscjftc三orrtmcehDVBiwixuioiti08phnn11UatiocBhrhotocp)Mng,ptbcatonpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanherequestedfromeitherISOattheaddressbe1.oworISsmemberbodyinthecountryoftherequester.%,tft晒Iandonnet8CH-1214*crnicr,GenevaPhone：M1.2274
3、9O1.11Pub1.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.
4、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userinformationAnnex A (informative)Guidanceonriskmanagemen
5、t8Annex B (informative)Designconsiderationsbasedonanatomy.11Annex C (informative)GuidanceforcreatingaRestrictedSubstance1.ist14Bib1.iography15ForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsttiugh(ISOmrtm匕山biftbni)r盟RAucekdWpnf1.QbbGgbodyICmitte
6、ehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofThepr
7、oceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceare崛则搬OfISO1.ECdj三-翩山糖ntW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-w4J
8、beintheIntroductionand/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,th
9、e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.SextoysDesignandsafetyrequirementsforp
10、roductsindirectcontactwithgenita1.ia,theanus,orboth1 Scopeformanufacturedproductsintendedforsexua1.use.assistivedocumentisnotprimari1.y1.ubricants,massageproductsc1.assifiedasmedica1.devices,cosmeticsor2 Normativereferencesconstitutesrequirements1.atesteditiondocument.referencedreferences,(inc1.udin
11、gamendments)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.supp
12、1.cmcntsxosmeticsorassistiveproducts;forexamp1.e,3.2intendeduseSOURCE:ISO14971:2019,3.6modified,processandservicede1.eted,a1.ternativetermde1.etedriskSOURCE:ISO/IECGuide51:2014,3.9JISO2021-A1.1.rightsreservedThisdocumentspecifiessafetyanduserinformationrequirementsre1.atingtothemateria1.sanddesignTh
13、isdocumentcoverson1.ymanufacturedproductsthatareintendedtocomeindirectcontactwithgenita1.sand/ortheanus.Thisproductsforexamp1.eintendedforoi1.Thefo1.1.owingdomentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentundatedreferences,theofthisoftheFordateddocumenton1.ytheanyeditioncitedForIS
14、O7000,GrQphicaIsymboIsforuseonequipmentRegisteredsymbo1.s37010,Graphica1.symbo1.sISOandIECmaintaintermino1.ogydatabasesforuseinstandardizationa1.thefo1.1.owingaddresses：IECE1.ectropedia:avai1.ab1.eathttps:/www.e1.ectropedia.org/manufacturedproductintendedforsexua1.stimu1.ationortoenhancesexua1.p1.ea
15、sureNote1coentry：oi1.,intimateCIasSifiedasfooddevices.useforwhichaproductisintendedaccordingtothespecifications,inst11ctions,andinformationprovidedbythemanufacturer(3.4)3.3 combinationoftheprobabi1.ityofoccurrenceofharmandtheseverityofthatharm3.4manufacturernatura1.or1.ega1.personwhomanufacturesorfu
16、1.1.yrefurbishesadeviceorhasadevicedesigned,manufactured,orft1.1.yrefurbished,andmarketsthatdeviceunderitsnameortrademarkNotieientUgatghttei.PoMbi1.itjessube1.htrd1.nductThethebase-to-neckratioshou1.dbeconsidered.EXAMPLE 1 Ana1.p1.ugs,ana1.beads,ana1.di1.dos.Mediumand1.argeproductssha1.1.havedesignf
17、eaturesmakingitpossib1.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.earinformatio
18、nintheuserinformationoftheintendedpurposeandhownottousetheproduct.Manufacturersshou1.dconsideraddingdesignfeaturesmakingretrieva1.possib1.eforforeseeab1.eana1.retention.5.2.2 Productsforgenita1.enc1.osuresextoyintendedforenc1.osinggenita1.sforexamp1.e,peni1.erigidityring,chastitydevices,etc.,sha1.1.
19、bmefdtRj11mgab1.e(1.rdhess)stt1.tfegentthhaonst11ied11chjsiBpa11sfeiMtd1.rowateOTitewtrth?commonhouseho1.dtoo1.ssuchasp1.iers.Theysha1.1.notrequiretheuseofpowertoo1.sforremova1.5.2.3 Movingandremovab1.epartsIftheproductisdesignedwithremovab1.epartswhichmayposeariskwhennotproper1.yfixeditsha1.1.whena
20、un1.ocked.mechanismwhichensuresthatthepartsstayinp1.aceduringuseandareon1.yre1.easedSX3MP1.EVibrationmachinewithrep1.aceab1.edi1.dos,batterycompartments.Hazardstotheuserfromvibrationsha1.1.beassessedintheriskana1.ysis.Manufacturerssha1.1.eva1.uateanyvibrationfrompoweredsextoysintheintendedenvironmen
21、t(三)ofuse.durationPOWerUdproductssha1.1.inc1.udeanautomatictime1.imitorc1.ear1.ystatemaximumtimeofJE5349-2,Jpg9rerscanconsiderstandardsre1.atingtotheeffectsofvibration,forexamp1.eISO5349-1,5.4E1.ectrica1.safetyThemanufacturersha1.1.considerthee1.ectrica1.safetyoftheproductduringthedesignphase,basedo
22、nintendeduseandreasonab1.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
23、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,takingi
24、ntoaccounttemperatureinertia.PhMiUCtmgiatort1.iedtteHOUIdtaeM1.tinafro购UXternai螭SOnab1.eambienttemperatureupto30andifthe5.6Designrequirementforwire1.essremote-contro1.1.edproductsForanyremote-contro1.1.edproduct,theunitthatisintouchwiththebodysha1.1.haveac1.earandsimp1.e5,toSrfa(CsQcorners,edges,and
25、protrudingpartswithgenita1.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
26、ssafety.6.2 Materia1.safety3ittNW1.wWdMfSha1.1.makesurethatnochemica1.sinquantitiesknowntobeharmfu1.fortheuserareThemanufacturersha1.1.estab1.ishaRestrictedSubstance1.ist(RS1.)inc1.uding1.imitsofsubstancesthatsha1.1.notbepresentinthemateria1.sthatcomeintocontactWithmucosa.Themanufacturershou1.destab
27、1.ish,imp1.ement,andmaintainaproceduretoidentifytheapp1.icab1.e1.awsandregu1.ationsofthecountrieswheretheproductsaremanufactured,imported,distributedandso1.d,inordertoensurethatapp1.icab1.e1.ega1.requirementsaretakenintoaccount.SeennexCforguidanceoncreatingaRestrictedSubstance1.ist.A1.1.materia1.saf
28、etyinformationsha1.1.hemadeavai1.ab1.eduringaprocurementprocess.6.3 Bioconipatibi1.itySextoysareproductswithrepeatedcontactWithmucosaandpossib1.ycompromisedtissue,sha1.1.Manufac1.urersbiocornpatib1.e.makesurethatthemateria1.s,thatcomeintocontactwithmucosaduringintendedForsextoys,on1.yinvitromethodss
29、ha1.1.beused.Dtntest1fereti吊算e0i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.bedonebyanaccre
30、dited1.aboratory.The1.aboratorysha1.1.conformwiththerequirementsinISO/IEC17025.Theresu1.tssha1.1.beinterpretedbyatoxico1.ogistoranotherqua1.ifiedexpert6.4 C1.eaningandmaintenanceThemanufacturersha1.1.infnntheuseraboutc1.eaningmethodsandmeansforthespecificproducts,in牙CuSejn1.4enorjmatihintendeduse.7.
31、1Genera1.Userinformationsha1.1.inc1.udea1.1.informationdirectedtotheconsumer.productthesesha1.1.beincorrespondencewithMarketinginformationsha1.1.heconsistentwithproductinformation.Thedistributorshou1.densurethattheconsumerinformationisavai1.ab1.eina1.anguageunderstoodbytheusers.7.2 Contentofuserinfo
32、rmationonproductInformationontheproductsha1.1.inc1.ude:C1.earindicationonhowtoturntheproductonandoff,ife1.ectrica1.1.ypowered1.ot,batch,orseria1.number,asfaraspossib1.e,orifthisisnotpossib1.eitsha1.1.beontheproductpackage7.3 PackagingInformationontheproductpackagingsha1.1.at1.eastinc1.ude: Descripti
33、onofprc1.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
