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.ementsandstru