CLSI-EP25-A(体外诊断试剂稳定性评价）.docxVIP

September2009

EP25-A

EvaluationofStabilityofInVitroDiagnosticReagents;ApprovedGuideline

Thisdocumentprovidesguidanceforestablishingshelf-lifeandin-usestabilityclaimsforinvitrodiagnosticreagentssuchasreagentkits,calibrators,andcontrolproducts.

AguidelineforglobalapplicationdevelopedthroughtheClinicalandLaboratoryStandardsInstituteconsensusprocess.

Clinical

ClinicalandLaboratoryStandardsInstitute

TheClinicalandLaboratoryStandardsInstitute(CLSI)isanot-for-profitmembershiporganizationthatbringstogetherthevariedperspectivesande