Medical device manufacturers and others involved in the supply chain have a responsibility to provide detailed information about medical devices. This information can be included on the packaging or in the accompanying documents.
The sterile barrier system refers to the primary packaging that is specifically designed to maintain sterility, protect the product from contamination, and allow for aseptic presentation. The protective packaging serves as an additional layer of defense for the sterile barrier system.
These functions include enabling sterilization, providing physical protection, preserving sterility until the device is used, and allowing aseptic presentation.
Focus on the production of disposable infusion sets which meet the requirements of CE and ISO 13485 according to REGULATION (EU) 2017/745.
