ISO 11607-2 Packaging for Final Sterilized Medical Devices - Part 2: Validity Requirements for Shaping, Sealing, and Joining Processes

The ISO 11607-2 standard has been designed by the International Organization for Standards (ISO) to describe the forming, sealing and joining properties and test methods of sterilized medical device packaging.

This standard has also been published in our country by the Turkish Standards Institute (TSE) under the following heading: TS EN ISO 11607-2 Packaging for final sterilized medical devices - Part 2: Validation conditions for shaping, sealing and joining processes.

This standard describes the requirements for the development and validation of the packaging processes of medical devices sterilized as terminals. These operations include the creation, closure and assembly of pre-formed sterile barrier systems and packaging systems. This standard applies to businesses, healthcare organizations, and wherever medical devices are packaged and sterilized. However, it does not cover the requirements for packaging aseptically manufactured medical devices. In some cases, additional requirements are required for drug and device combinations.

For medical devices sterilized as terminals, the packaging must be designed and manufactured so that the medical device can be sterilized and remain sterile under storage and transport conditions until the sterile barrier system is damaged or opened. One of the most critical features of a sterile barrier system and packaging system for sterile medical devices is the assurance of sterility care. Medical devices delivered sterile must be manufactured, packaged and sterilized by validated methods.

Within the framework of laboratory testing services, our organization also provides services for TS EN ISO 11607-2 sterilized medical device packaging materials, shaping, sealing and joining processes.