1. Microbial barrier

  the ability of the sterile barrier system to prevent the entry of microorganisms under specified conditions

2. Packaging material

  any material used to manufacture or seal packaging systems

3. Packaging system

  combination of sterile barrier system box and protective packaging

4. Preformed sterile barrier system

  sterile barrier system partially assembled for loading and final closure or sealing

5. CE mark (CE marking / CE mark)

   medical device manufacturers must obtain CE mark or CE mark certification before they can distribute their products to the European Union (EU) market. The CE       mark is issued by a third party organization (i.e. notified body) to indicate compliance with applicable EU medical device regulations.

6. Seal integrity

  sealing under specified conditions ensures the characteristics of preventing the entry of microorganisms

7. Seal strength

  mechanical strength of seal

8. Sterile barrier system

  the smallest package that prevents the entry of microorganisms and enables the product to be used aseptically at the place of use

9. Sterilization compatibility

  the characteristics of packaging materials and / or systems that can withstand the sterilization process and make the final packaging meet the conditions           required for sterilization.

10. Useful life

   the period during which the product can maintain safe working ability under the service conditions specified by the designer or manufacturer is called service life.