Construction Of Packaging For Terminally Sterilized Medical Devices Test Capability And Verification Of Typical Package

This thesis is a research of packaging for terminally sterilized medical devices.The study includes the definition,standardization,the status of the industry,application,the test capacity building,and verification experiment of typical package.Packaging for terminally sterilized medical devices is a kind of primary package,which can be sterilized,maintain sterility before use,so that the medical device can be used aseptically finally.The quality of the packaging has a profound influence on the quality of the final sterilization medical devices.This thesis describes the creation of the domestic and international standard system of packaging.The history of the renowned international Organization for Standardization is also summarized.This thesis compares the difference of key parameters and the required level between domestic and foreign standards analysis.By comparing the correspondence between EN868,ASTM series standard and industry standard,the author made a detailed comparison table.This thesis describes the commonly used forms of sterilization for medical devices,depending on the demand of medical device manufacturers and medical institutions,the application of packaging for terminally sterilized medical devices will be explained.In this thesis,the author analyzes the different types of packaging features and quality control key points,describes the concept,characteristics,types,assembly and management of factory packaging and hospital packaging respectively.The thesis also shows some of the problems existing in the present market.At the same time the author expounds the application of packaging for terminally sterilized medical devices in the disinfection supply center of hospital.Since then the author analyzes the specific needs of building test capacity.According to the existing test ability of BIMT,the basic requirements and parameters of the inspection equipment and the forming equipment are determined,and then completed the construction of the test capability.Finally,after the construction of packaging for terminally sterilized medical devices test capability,the author conducted a verification experiment to paper,non-woven fabric and Tyvek,and obtained the difference between the conclusions of the three products.