医疗药品CE技术资料EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedure.pdfVIP

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医疗药品CE技术资料EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedure.pdf

June2012

EP17-A2

EvaluationofDetectionCapabilityforClinical

LaboratoryMeasurementProcedures;

ApprovedGuideline—SecondEdition

Thisdocumentprovidesguidanceforevaluationanddocumentationof

thedetectioncapabilityofclinicallaboratorymeasurementprocedures

(ie,limitsofblank,detection,andquantitati

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