YY 0033 英文版本 官方翻译 Good Manufacture Practice for St

RecordNo.0854-2001C30MedicalIndustryStandardofPeople’sRepublicofChinaYY0033-2000GoodManufacturePracticeforSterileMedicalDevicesIssuedon2000-08-18Implementedon2009-09-15IssuedbyStateDrugAdministration(SDA)YY0033-2000PrefaceThisstandardisthefirstrevisionofYY/T0033-1990GoodManufacturePracticeforSterileMedicalDevices.ThepurposeofthisrevisionistocarryouttheRegulationontheSupervisionandManagementofMedicalDevices.Atthesametime,inordertostrengththesupervisionandmanagementofmedicaldevicesandtoensurethesafetyandeffectivenessofmedicaldevices,transformthisvoluntarystandardintocompulsorystandard.MaindifferencesbetweenthisstandardandYY/T0033-1990:a)Change“organizationandpersonnel”to“qualitysystem”,requireenterprisesmanufacturingsterilemedicaldevicestoestablishandimplementeffectivequalitymanagementsystemandtobuildcompletedocumentsofqualitymanagementsystem.b)Change“productionenvironmentandlayout”to“productionenvironment,facilityandlayout”,addtherequirementsofwaterandwireline,workingtable,compressedair,etcincleanroom(area);andaddpurificationrequirementsandprocesslayoutrequirementstopersonnelandmaterialsenteringintocleanroom(area);c)“Facilityandworkclothes”,addtherequirementsofprocesswaterpreparation,storageandconveyingequipments;d)Change“materialandout-purchasedpieces”to“purchasingandmaterialmanagement”,proposetheevaluationtosuppliers;e)Change“technicaldocument”to“document”,besidetherequirementtotechnicaldocument,alsorequireenterprisestoestablish“qualitymanual”and“processdocument”,andproposethecontrolrequirementtodocuments;f)Change“qualityinspectionandsupervision”to“qualitymanagement”;g)“Productionprocessmanagement”,add“productlabelingandtraceability”,“controlofnonconformingproduct”,“correctiveandpreventiveactions”etc,andsupplementthecontentofpackagemark;h)“Productdistributionandcustomerservice”,enterpriseshouldestablishtheadverseeventreportsystem,incidentreportsystemandproductrecoverysystemofsterilemedicaldevices;i)DivideappendixB“environmentrequirementandapplicationscopeofcontrolarea,cleanarea”intoappendixB“SettingPrincipleofCleanlinessClassofProductionEnvironmentforSterileMedicalDevice”andappendixC“EnvironmentRequirementandMonitoringforCleanRoom(area)ofSterileMedicalDevice”;j)addappendixD“GeneralProcedureofPersonnelInandOutofCleanProductionArea”,appendixE“verificationandvalidation”andothernormativeappendix.Part5,6,7,11ofthisstandardiscompulsory,othersarevoluntary.Fromtheeffectivedate,thisstandardreplacesYY/T0033-1990.AppendixesA,BandCofthisstandardarenormative.AppendixesD,EandFofthisstandardareinformative.ThisstandardisproposedbyStateDrugAdministration(SDA).Mainparticipatingorganization:SDAJinanMedicalDeviceQualitySupervisionandTestingCenter.Otherparticipatingorganizations:SDAMedicalDevicesDivision,ChinaQualityCertificationCenterforMedicalDevices,TianjinHanacoMedicalCo.,Ltd.andShanghaiFoodandDrugAdministrationDrugTestingCenter.MainDraftsmen:WangYanwei,PuChangsheng,ShiYanping,ChenZhigang,CaoChenguang,ChenYong,WuZhenmin,JiWei.MedicalIndustryStandardinPeople’sRepublicofChinaYY0033-2000GoodManufacturePracticeforSterileMedicalDevicesReplaceYY/T0033-19901.ScopeThisstandardstipulatesthegeneralrequirementsofproductionandqualitymanagementforsterilemedicaldevicesandthecomponentsandparts.Productionofprimarypackagematerialofsterilemedicaldevicesalsoshouldmeettherequirementsofthisstandard.2.QuotedStandardsItemsfollowingstandardscomposethecontentofthisstandardthroughbeingquoted.Followingstandardsareeffectivewhenissuingthisstandard.Allstandardswouldberevised,usersshouldrefertotheupdatedversionofthesestandards.GB/T6583-1994QualityManagementandQualityAssuranceTermsGB/T16292-1996TestingMethodofAirborneParticlesinCleanRoom(Area)ofMedicalIndustryGB/T16293-1996TestingMethodofAirborneMicrobeinCleanRoom(Area)ofMedicalIndustryGB/T16294-1996TestingMethodofSettlingMicrobeinCleanRoom(Area)ofMedicalIndustryYY/T0313-1998Package,Labeling,TransportationandStorageofMedicalPolymerJGJ71-1990ConstructionandAcceptanceSpecificationofCleanRoom3.Definitions:ThisstandardusethedefinitionsinGB/T6583andYY/T0313andfollowingdefinitions.3.1LotAcertainquantityofaproductwithsamepropertyandqualityproducedunderrelativelystablecondition.3.2LotNumberAsetofnumbersorcapitalsandnumbersusedtoidentify“lot”,whichwouldtraceandreviewtheproductionhistoryofthislotofproducts.3.3ProductionLotInaperiod,acertainquantityofaproductwithsamepropertyandqualitycontinuallyproducedunderasameprocess.Note:Tosomecontinuallyproducedproducts,sometimesit’sdifficulttodeterminetheproductionlot.Fortheneedofmanagement,usuallytaketheproductsproducedinoneworkingdayorshiftastheproductionlot.3.4SterilizationLotInasamesterilizedcabinet,acertainquantityofaproductwithsamesterilizationlevelsterilizedundersameprocess.3.5SterilizationAvalidatedprocessusedtomakeproductsfreeoflivingmicrobiologyinanyshapeorform.3.6SterileMedicalDevicefreeoflivingmicrobiology.3.7PrimaryPackagePackagedirectlycontactedwithsterilemedicaldevice.3.8SterileMedicalDeviceAnymedicaldeviceidentifiedas“sterile”.3.9CleanRoom(area)Room(area)needt