ISO 04904-2023.docx

INTERNATIONA1.STANDARDISO4904editionFirst2023-10Traditiona1.ChinesemedicineInnerpackofdecoctionpiecesMdecineIraditionne1.1.echinoise-Sachetinternedesdecoctions©ISO2023COPYRIGHTPROTECTEDDOCUMENT©ISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.o啪InPSd1.Mc;GeatrOn1.(nm11nr1amaqmr6pW11opyp>iiuonmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountr)oftherequester.f),WV>fifiU81.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForewordivIntroductionv2 Scope13 Normativereferences14 Termsanddefinitions15 Physica1.propertyrequirementsforinnerpackofdecoctionpieces26 Requirementsforinnerpackmateria1.sofdecoctionpieces3Settingofpackingdosespecifications36 Sed1.ngprincip1.es7 2Specificationrequirements478 Requirementsfor1.abe1.s4Requirementsforquickresponse(QR)codes581QRCOdearea.9 8.2QRcodescanningresu1.ts5Requirementsforco1.ourcodes6AnnexA(informative)Specificationsandcorrespondingco1.ourcodesforInnerpackofdecoctionpieces7Bib1.iographyForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsUudiugh(ISOtdm0ibif1.4>Ri)tRvcekcWMpbBr)gbody1.1.tHrwtttti1.6tanddiif(JTOWhidr1.arrted>>mitteehasbeenestab1.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孤籽福四槛OfISO雇附暇I1.VeS,s颜tUM*note每幅M蝴腺科思嘟r则jter0rdancetheeditoria1.ru1.esoftheISO/IECDirectives.Part2(seewww.iso.org/direc1.ives).假)(¾徽entSh圈能ntakest三嬲据i帆n曲1.fiB胸硼8确画Ftm部幽曲野榴IVQdaimedpatentrightsinrespectthereof.Asofthedateofpub1.icationofthisdocumentISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimp1.ementthisdocument.However,imp1.ementorsare蜘临翻琳“nWww.isoQFg/.ents洗蝮油那ion,扁MMSPOn赖岫油嬲9的阳躲Ora"suchpatentrights.Anytradeusedinthisconstitutenameendorsenent.documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand幽幽蛔豳酒侬遮W即辆O)assEif1.眦聚inwe帼"1.见OnBar池帆四dead邮&CcsVbr¼11isoorgisoforeword.htmI.ThisdocumentwaspreparedbyTechnica1.CommitteeISO/TC249,Traditiona1.Chinesemedicine.AnyfeedbackorquestionsonthisdocumentShaUIdWdimUstandardsbody.Acomp1.ete1.istingofthesebodiescanbefoundatwww.iso.org/members.htm1.IntroductionPackingmateria1.usedfortheinnerpackofdecoctionpiecesshou1.dmeetbasicqua1.itycriteria,becausethtenationaW(rfargw±H!twtardtiiitcotarnsGhhtariDtfhwf!tpin?AtnaWkagingJ11ecf1.ferB)theinnerpackagingisoftennotstandardized,notincomp1.iancewithhygienicrequirements,notsuitab1.eforthepackagingofmedicinesandnotapp1.icab1.etothenatureofdecoctionpieces.Hence,theinnerpackshou1.dbestandardizedtoensurethequa1.ity,safetyandefficacyofdecoctionpieces.Inviewofthecurrentsituationwherethereisoftennoinnerpackofdecoctionpiecesortheinnerpackisnotincomp1.iancewithre1.evantrequirements,thisdocumentpromotestheharmonisationHd曲福或燃幽幽品Onan邮屋。狷芭帆Pr隋ffin拓挑CeSS融rrers:ig图H三旅,而BfWf鼬ationandmodernizationofChinesemedicines.Traditiona1.ChinesemedicineInnerpackofdecoctionpieces1 Scopeinc1.udingpackagingmateria1.s,physica1.properties,specificationsand1.abe1.s.2 Normativereferencesconstitutesrequiremcnts1.atesteditiondocurnent.referencedreferences,(inc1.udingamendments)app1.ies.app1.ies.theuniqueidentificationandexchangeOfregu1.atecimedicina1.productinformationapp1.icationofISO9001:2015,withreferencetogoodmanufacturingpractice(GMP)ru1.esforChinesemedicinesdecoctionpiecesISO21371rTraditiona1.ChinesemedicineIxihe1.1.ingrequirementsofproductsintendedforora1.ortopica1.materia239631.,Traditiona1.ChinesemedicineRequirementsforprocesstraceabi1.itysystemsinChinesemateriamedicoanddecoctionpieces-Part2:E1.ectronic1.abe1.1.inggenera1.useandpackagingapp1.icationsdensitypo1.yethy1.eneforgenera1.useandpackagingapp1.ications3 TermsanddefinitionsSOandIECmaintaintermino1.ogydatabasesforuseinstandardizationatthefo1.1.owingaddresses：©ISO2023-A1.1.rightsreservedThisdocumentspecifiesrequirementsfortheinnerpackOfdecoctionpiecesofChinesemedicines.Thisdocumentisapp1.icab1.etothemanufacturing,inspection,operation,circu1.ation,use,supervisionandmanagementofinnerpackofdecoctionpieces.Thefo1.1.owingdocumentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentundatedreferences,theofthisoftheEordateddocumenton1.ytheanyeditioncitedForISO11615rHea1.thinformaticsIdentificationofmedicina1.productsDatae1.ementsandstructuresforISO15378rPrimarypackagingmateria1.sformedicina1.products-Particu1.arrequirementsfor1.heISO18668-1:2016,Traditiona1.ChinesemedicineCodingsyfstemforChinesemedicinesPart1:CodingISO18668-2,Traditiona1.ChinesemedicineCodingsystemforChinesemedicinesPart2:CodesforISO20333rTraditiona1.ChinesemedicineCodingru1.esforChinesemedicinesinsupp1.ychainmanagementuseISO22217rTraditiona1.ChinesemedicineStoragerequirementsforrawmateria1.sanddecoctionpiecesISOmedicadecoctionpiecesPan1：ComponentsISO23963-2,Traditiona1.ChinesemedicineRequirementsforprocesstraceabi1.itysystemofChineseASTM1)3981,Standardspecificationforpo1.yethy1.enefi1.msmadefrommediumdensitypo1.yethy1.eneforASTMD4635,Standardspecificationforp1.asticfi1.msmadefrom1.ow-densitypo1.yethy1.eneand1.inear1.ow-Forthepurposesofthisdocument,thefo1.1.owingtermsanddefinitionsapp1.y.ISOOn1.inebrowsingp1.atform:avai1.ab1.eathttps:/www.iso.org/obp31.IECE1.ectropedia:avai1.ab1.eathttps；/WWW,e1.ectfope<1.iaQrg/innerpackq,kageindirectcontactwithdecoctionpieces(3.2)decoctionpieceprescriptionmedicina1.processedfromChineseMateriaMedicainaccordancewithtraditiona1.ChinesemedicineandprocessingmethodsforChinesemedicines,whichcanbedirect1.yusedinc1.inica1.practiceortheproductionofpreparedmedicinesSOURCE:ISO18668-1:2016,3.3,modified"underguidance"rep1.acedby"inaccordancewith".Notej里entryhasbeenmergedintothedefinition.co1.ourcodedifferentco1.oursusedonthePaCkagew1.abe1.ofdecoctionpieces(3.2)forindicatingdifferentReifications,inc1.udingco1.ourcard(3.4)number,RGBandHEX/HTM1.co1.ourcardspecificco1.ourdefinitionsareprovidedbydifferentcompaniesandareusedforco1.ourcommunication貂temsinvariousareas,inc1.udingprinting,texti1.e,p1.astics,drawinganddigita1.techno1.ogyinnerpackmateria1.smateria1.swhichara-usedtomanufacturethepackagingbagswhichareindirectcontactwiththedecoctionpieces(3.2)4 Physica1.propertyrequirementsforinnerpackofdecoctionpieces4.1Thephysica1.propertiessha1.1.beinaccordanceWithISO15378,ASTMD3981andASTMD4635.Bagsfortheinnerpackofdecoctionpiecessha1.1.besea1.edairtightandthesurfacesha1.1.bec1.eanandwithoutanydamage,agingorforeignmatterattached,de1.aminationorotherabnorma1.ities.4.2p1.eatsVisua1.inspectionsha1.1.beundernatura1.1.ight,thesurfaceofpackagingshou1.dbesmoothwithout4.3IranSParentCOnHnUoUgthpackaging,mm.connectionpartbetweentwoadjacentpackagesshou1.dbe4.4avoidIosseshigh-Costcontaminationresu1.tingfrommeasurespackaginginpackagingsha1.1.storageandtransportationdueto1.oadingandun1.oadingco1.1.ision.H鹿碗冲W加虫瞅esC0俐y布遍照If幽InWn1.yknownasCordyceps4.5notab1.yDecoctioncorrespondinganestheticonandpsychotropicsha1.1.bedoub1.epackagedandmarkedDoWHJo"8n痴Art印od""mu1.sfih<ti口dothe<ip>Ghotropiconcs.usesmayinc1.uderea1.gar.Daturastramonium5 Requirementsforinnerpackmateria1.sofdecoctionpieces5.1productschemica1.breathab1.ewhichnon-toxic,degradedasinshortfibres,po1.ypropy1.eneenvironment,EXAMP1.EtoPackagingInatena1.manufacturerspackagingofdecoctionpackagingmateria1.sstandardare5.25.3friend1.inesstcharacteristicsbepcrmcabi1.ity,moisture-resistance,pressure-resistanceandenvironmenta1.5.45.5Tab1.e1-Typesofinnerpackmateria1.sSuitab1.efordecoctionpiecesPo1.yethy1.enePIaSdCfi1.m-P1.asticG1.assconuinerG1.assNOTESeeASTMD3981andASTMD4635.6Settingofpackingdosespecifications6.1 Settingprincip1.esc1.inician'sprescription.©ISO2023-A1.1.rightsreservedInnerpackmateria1.ssha1.1.bepurchasedfromqua1.ifiedmanufacturingenterprises,whichobtaineda1.icencetoproducepackagingmateria1.forfoodandmedica1.use.Toxicmateria1.swith"ch1.orine*andrecyc1.edtoxicmateria1.ssha1.1.beprohibited.Itisrecommendedtousepackagingstrongerthatarestructure,andcanbesuchp1.anttimeorvithoutpo1.1.utingthemateria1.swithaandwhichcanberecyc1.ed.qua1.ifiedde1.iverpackagingfortheinnerwhichfu1.fi1.1.theBRCGSpieces.decoctionpieces,materia1.sandcontainersreactionse1.ectedtheinaccordanceWithpiecespropertiesnotaffectthequa1.ityofthedecoctionpieces.orpartia1.1.ytransparent,tokeepnon-toxic,Steri1.eMSibIefromwithoutContaminationpackagingtiansparentforpackagingandtheuseoftoxicmateria1.sisprohibited.Inaddition,innerpackmateria1.ssha1.1.possesscertainandShou1.dofrecyc1.ab1.eordegradab1.e.Innerpackmateria1.sofdecoctionpiecessha1.1.bedisposab1.e.TypesoUmuMpackmateria1.sWhiChshou1.dbeused,andthere1.evantscopeoftheirapp1.icationsareshowninTab1.e1.ScopeTypeSubtypcMateria1.pkceswmvifiudngc5St11ti31dco)ctiraR1.s,Settheminimumnumberofspecificationstothemaximumextentpossib1.etomeettheneedsofthe6.2 Specificationrequirements6.2.1Thereare15innerpackweightspecificationsfordecoctionpieces:1g,3g,5g.6g,9g,10g,12g.15g,30g,50g.75g,250g,500g,1000gand>1000g.6.2.2Deviationrequirements：dcviatioiMttpackagingamountofinnerpackdecoctionpiecessha1.1.beconsistenttheufigbk»4；WeigtonceCInU6nefOryhePqdc值extiG(R3a)R今城tbe30理ighttt1.kibSatUtWeigM蜘加上Wdwithanaccuracyof1%oftheweighttaken)andthencomparingthepackingweightofeachpackagetothemarkedpackingweight.NomorethantwopackagescanexceedthepermittedpackingweightvariationandnoneofthemCansurpasstwicethepermittedvariation.Testmethodofpackingweightvariationforthespecificationsof250g:takingthreetestpackagesandweighingthemrespective1.y(theweightthatisweighedsha1.1.bewithanaccuracyof1%oftheR<j11ft6F8捆怕阳阕庆便IftW1.tspiftR湖的照飒ngn瞄WWAhfothrequirement,thenanotherthreetestsamp1.eswi1.1.becheckedanda1.1.thethreeofthemshou1.dconformtotherequirements.Tab1.e2-RequirementsonpackingweightdeviationofdecoctionpieceswithinnerpackItemnumberMarkedweightorpackingweightPermitteddeviationfromthemarkednumber6Z5Upguu。UUgand±3%6.3OtherrequirementsForanydecoctionpiecewhosedosageunitisnotconsideredintermsofweight,suchascentipede(one),there(½oqc1.*nGtddHb11mdpraghption.specifications.Suchdecoctionpiecesshou1.dbeprocessedasper7Requirementsfor1.abe1.s7.11.abe1.shou1.dbeprintedonormarkedontheinnerpackOfdecoctionpiecesandsha1.1.fo1.1.owtherequirementsofISO11615andISO21371.7.2shou1.dtorecognize.expressionbescientific,standardizedandaccuratemarkingshou1.dbenofaded1.etteringandno1.oose1.yattached1.abe1.s.Anyadditionormodificationshou1.dnotbemadebymeansofpasting,cuttingora1.tering.7.3Nationa1.orregiona1.regu1.ationscanapp1.ytothe1.abe1.softoxic,psychotropicandnarcoticdecoctionpieces.7.4decoctionpiecesspecia1.requirementsonstorage,therequirementsshou1.dbemarkedonthe7.5audio/ViSUa1.unapprovedmateia1.sbeinsertedintothedecoak>npiecespackagetopub1.icize7.6The1.abe1.ofdecoctionpiecessha1.1.at1.eastcontainthefo1.1.owinginformation:a) trademark;b) name(inaccordanceWithstandardizednames1.istedinISO18668-2);c) 1.atinbinomia1.nameandpart；d) p1.aceofproduction；e) preparationmethod;f) packingweight;g) barcode(inc1.udingQRcode)(inaccordancewithISO18668-1,ISO20333,ISO23963-1andISO23963-2);h) productbatchnumber;i) dateofproduction：j) expirydate(ifnecessary);k) storagecondition;国EXAMP1.EForbiddenforpregnantandIacutingwomen.m)manufacturingenterprise;#)Ruiwtat*钿由鄙陶,nted.response(QR)codes8.1 QRcodeareaForfastrecognition,theQRcodeareashou1.dbebiggerthanonesixteenthoftheareaoftheinnerpacktoeria1.diiSrt1.Qfiwndert8Hbu1.1.ih11HriQttadb(Utaateria1.innerpackmateria1.withadhesivestickersand1.abe1.s8.2QRcodescanningresu1.tsQRcodescanningresu1.tssha1.1.fo1.1.owISO23963-1andISO23963-2andat1.eastinc1.udethefo1.1.owinginformation：a) enterprisename;b) productname;c) productbarcode;d) productcategory；e) codesfordecoctionpiecesbasedonISO186681andISO18668-2;f) brand;g) SPeCifiCation/type;©ISO2023-A1.1.rightsreservedh) p1.aceofproduction;i) preparationmethodj) expirydate(ifnecessary);k) storageconditionl) storagemethodsbasedonISO22217;m) netcontent;n)executivestandards(re1.evantstandards);o) descriptionofproducts(effect);p) enterprisewebsite;q) manufacturefactory;r) productionaddress;s) periodofva1.idityforrecords.9Requirementsforco1.ourcodes9.1Co1.ourcodeapp1.icationprincip1.es:Theapp1.icationofco1.ourcodesshou1.dfo1.1.owtheprincip1.eofmarkecinessandobviouschromaticaberration.Differentvarietiesofthesamespecificationshou1.dusethesameco1.our.Specificationsofinnerpackofdecoctionpiecesandtheircorrespondingco1.ourcodearepresentedinAnnexA.9.2Theco1.ourcodesha1.1.beattachedtothepackingbagor1.abe1.andmarkedonthecentra1.areaoftheinnerpackmateria1.intheformofaco1.ourstripe.Theareaoftheco1.ourstripshou1.dbebiggerthanonefourthoftheareaoftheinnerpackmateria1.9.3Co1.ourcodesadoptthefo1.1.owingprintingmethods:a) Printdifferentco1.oursdirect1.yontheinnerpack.Thismethodisapp1.icab1.etoinnerpackthatusesco1.ourstripeprinting1.abe1.sanddirect1.yprintsdedicated1.abe1.sontransparentp1.asticbags.b) Usese1.f-adhesivepaperswithsevera1.differentunderpaintingstoprint1.abe1.s.Eachco1.ourrepresentsaspecification.Thismethodisapp1.icab1.etoinnerpackswith1.abe1.sattached,suchasfu1.1.y-transparentp1.asticbags.AnnexA(informative)Specificationsandcorrespondingco1.ourcodesforinnerpackofdecoctionpiecesNo.Co1.ourusedRGBHEX/HTM1.Entitysamp1.eSpecificationNOTEForspecifications>75r,thereisnoco1.ourcardstipu1.ation.(H23617Bib1.iographyb醐ng:RtM由财WP网ei0的10fePeop1.e'sRepub1.icofChina.Eng1.ished.ChinaPharmacopoeiaCommission.PhannacopoeiaofthePeop1.e'sRepub1.icofChina.Part1.Beijing:ChinesemedicinesandTechno1.ogyPress,201SGB/T4122.1,PackagingTennsPart1：BasisGB/T4456,Po1.yethy1.eneB1.ownFi1.mforPackagingApp1.icationsYY0236,CompositeFi1.mforPackingApp1.icationsGenera1.Ru1.es1.ipingr1.,Aipingr1.,Qingming,Z.oftheonNationaICodingSystemofChinese(TCM)StandardDeve1.opmentInterDretationExpenenceStandardsonTraditiona1.ChineseMedicineMe