BS EN 12322-1999 体外诊断医疗装置.微生物培养基.培养基性能标准

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【英文标准名称】:Invitrodiagnosticmedicaldevices.Culturemediaformicrobiology.Performancecriteriaforculturemedia
【原文标准名称】:体外诊断医疗装置.微生物培养基.培养基性能标准
【标准号】:BSEN12322-1999
【标准状态】:现行
【国别】:英国
【发布日期】:1999-08-15
【实施或试行日期】:1999-08-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:微生物分析;污染;培养基;培养(生物);保存;培养容器;医疗实验室设备;临床实验室设备;维修;诊断(医学);等级(质量);性能试验;质量控制;医疗设备
【英文主题词】:Bacterialstrains;Classification;Clinicallaboratoryequipment;Contamination;Culturecontainers;Culturemedia;Cultures(biology);Definitions;Diagnosis;Diagnosis(medical);Features;Grades(quality);In-vitrodiagnostic;Maintenance;Medicaldevices;Medicalequipment;Medicallaboratoryequipment;Medicalproducts;Medicalsciences;Microbiologicalanalysis;Microbiology;Microorganisms;Multilingual;Performance;Performancetesting;Preservation;Qualityassurance;Qualitycontrol;Ratingtests;Specification(approval);Straincultures
【摘要】:ThisEuropeanStandardspecifiesrequirementsfortheperformanceofculturemedia.Itisconcernedwiththetraceability,comparability,reproducibilityandsuitabilityofculturemediausedinmicrobiologicallaboratories.Thesecharacteristicsareachievedbyapplyingthequalitycriteriaoutlinedinthisstandard.ThisEuropeanStandardisapplicableto:a)commercialorganizationsdistributingmediatomicrobiologylaboratoriesinready-to-useform,asdehydratedmediaorassemi-finishedmedia(see2.5inEN1659:1996);b)non-commercialorganizationsthatdistributemediatosatellitelocations;c)laboratoriesthatprepareculturemediafortheirownuse.Cellculturemediaarenotcoveredbythisstandard.
【中国标准分类号】:C30
【国际标准分类号】:07_100_10
【页数】:14P.;A4
【正文语种】:英语