UL标准 医疗器械包装测试(ISTA2A 和 ISO 11607 要求) 英文版.pdf

PACKAGINGTESTINGFOR MEDICALDEVICES

ISTA2AandISO11607Requirement

AGENDA

IntroductionRegulations/StandardRequirementBriefonISTA2A(InternationalSafeTransitAssociation)PackageIntegrityTest.CombinedstabilityandpackagingvalidationULIndiaServices

INTRODUCTION

requirement.

regulationsandobtainaCEMark.

FulfillingISO11607 ensuresphysicalprotectionandmaintainssterilityupto thepoint of use.

Packagingtestingismeasuringthecharacteristicsandpropertyofpackingmaterial

Mostprecariousfactoristhesterilitywhichshouldbemaintainedthroughthedistributionandstorage.

Testinganewpackagingdesignbeforefullscalemanufacturingcansavetimeandmoney

INTRODUCTION

Many manufacture conduct packaging testing in-house or through thirdpartylab(ISO/IEC17025accredited)TestingandvalidationshouldbeinpliancetoISO11607-1anddesignedtomeetthepliancewithFDA ISO ENandCEmarkrequirements.

PackageValidationTestingisvitaltoensureintegrityof thepackage'sseal

SIMULATIONOFLIFECYCLEOFAMEDICALDEVICE? TYPICALLIFECYCLE