A useful and concise overview of important mechanical and physicochemical tests for validation of packaging processes of sterile medical devices according to international standards

The word of medical devices has many meanings in different countries of the world. But in general, these devices are any device that is used in medical science to diagnose, prevent and treat many diseases. In fact, each of these devices have been made and marketed by manufacturers in this field with a specific purpose. All of these devices are made for the purpose of human health. The packaging process of sterile medical devices is very important and complex. The process design of the packaging system and the selection of packaging materials depend on the nature of the medical device, sterile methods, expiration date, transportation and maintenance of the medical device, and this process must be designed effective and suitable. Packaging of sterile medical devices must be completely safe when it reaches the end consumer without any defects, damage or contamination. It is article, we done an overview of important standard mechanical and physicochemical tests of validation of packaging processes of sterile medical devices. These test includes air permeance, GTR test, dye penetration, pH, tensile properties, wet tensile properties, basis weight and tensile properties of thin plastic sheeting according to international standards

کلیدواژه ها:

mechanical and physicochemical tests ، standard ، validation ، process ، packaging ، sterile medical devices