【英文标准名称】:Biotechnology-Guidanceonassessmentofthepurity,biologicalactivityandstabilityofmicro-organismbasedproducts
【原文标准名称】:生物技术.微生物制品的纯度,生物活性和稳定性评估指南
【标准号】:BSEN12689-1998
【标准状态】:现行
【国别】:英国
【发布日期】:1998-12-15
【实施或试行日期】:1998-12-15
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:微生物;质量保证体系;稳定性;含量测定;规范(验收);质量保证;纯度;生物分析和试验;污染物;微生物分析;记录品(文献);农业;生物工艺学;生物技术;污染
【英文主题词】:
【摘要】:ThisEuropeanStandardgivesguidanceontheassessmentoftechnicalspecificationsofmicro-organismbasedproducts(MBPs)forproductqualityevaluation.Itisalsoapplicableforpurposesofproductregistration.NOTE1InthisEuropeanStandard,thetechnicalspecificationsareconsideredtobepurity,biologicalactivityandstabilityofthemicro-organismbasedproduct.ThisEuropeanStandarddescribescriteriaandfactorsconsideredforthevalidityoftheassessmentofthetechnicalspecifications.ThisEuropeanStandardonlyappliestothemicrobialcomponentsofaMBPasawholeanddoesnotapplytoanytypeofmolecularcomponentspurifiedfromthemicro-organism.ThisEuropeanStandardappliestoMBPsspecificallymanufacturedtobeusedinagricultureandintheenvironment.ThisEuropeanStandarddoesnotapplytoMBPsusedeitherinfoodindustry,forveterinaryuseorforhumanhealth.NOTE2ThisEuropeanStandardcanbeusedbythemanufacturerofMBPsoranyoneinterestedintheevaluationofproductquality.NOTE3Duetorapidevolutioninthisfield,itisrecommendedthattheusershouldconsultexistingapplicablenational,Europeanandinternationalstandards.NOTE4Technicalspecificationassessmentisconsistentwiththeneedforprotectionofhumanhealth,animalandenvironmentalsafety.
【中国标准分类号】:C04
【国际标准分类号】:07_080;07_100_01
【页数】:10P;A4
【正文语种】:英语