根据ISO标准进行工艺验证的重要性

Importance of process validation according to ISO Name: MatíasPilasiPendásAffiliation: INDE / P&ECONTENTINTRODUCTIONBACKGROUNDWHY IS VALIDATION NEEDED?ISO STANDARDS FOR VALIDATIONHOW IT IS CARRIED OUTCONCLUSIONSINTRODUCTIONUseThe reprocessing of Medical Devices is a complex task, involving 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 Reprocessing cycleImage translated from DGSV (German Sterilization Society)Pre cleaningDismantlingDischargeINTRODUCTIONAccording 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 must be STERILEINTRODUCTIONHow do me measure the sterility of Medical Devices?It´s not possible……INTRODUCTIONProblemInstr