根据ISO标准进行工艺验证的重要性.pdf

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1、Importance of process validation according to ISO Name:Matas Pilasi PendsAffiliation:INDE/P&ECONTENTCONTENTINTRODUCTIONBACKGROUNDWHY IS VALIDATION NEEDED?ISO STANDARDS FOR VALIDATIONHOW IT IS CARRIED OUTCONCLUSIONSINTRODUCTIONINTRODUCTIONUseThe reprocessing of Medical Devices is a complex task,invol

2、ving different steps and processes which finally leads to a functional,clean,disinfected and/or sterile device that must be safe for the patient and users.CleaningDisinfectionDryingPackagingLabellingVisual ControlCareFunctional testsSterilizationDocumentedrelease StorageDistributionMedical Devices R

3、eprocessing cycleImage translated from DGSV(German Sterilization Society)Pre cleaningDismantlingDischargeINTRODUCTIONINTRODUCTIONAccording to good practices from an Infection Control and Safe Surgeries perspective,Medical Devices that will come in direct contact with sterile areas of the human body

4、must be STERILEINTRODUCTIONINTRODUCTIONHow do me measure the sterility of Medical Devices?Its not possibleINTRODUCTIONINTRODUCTIONProblemInstruments are packed(protected)and therefore sterility cannot be checked after the instruments come out of the sterilizer.Sterilization conditions are not homoge

5、neous inside the sterilization chamber.These conditions cannot be directly measured during routine practice.Hollow instruments have a higher challenge for steam sterilization than solid instruments.The challenge depends on the material,length,diameter and wall thickness.DEFINITIONSBACKGROUNDBACKGROU

6、NDSterilization:validated process to deliver products free of any viable microorganism.Sterile:Free of viable microorganisms.EN 556:Sterile Assurance Level(SAL)10-6WHO 2016:labelling a health care product with the word sterile is only permissible when a validated sterilization process has been used.