ISO 11607-2 Packaging for Sterilized Medical Devices - Part 2: Verification Requirements for Forming, Sealing and Assembly Processes

EUROLAB laboratory provides testing and compliance services within the scope of ISO 11607-2 standard. Developed by the International Standards Organization (ISO), this part of the ISO 11607 standard specifies the requirements for the development and verification of processes for the packaging of sterilized medical devices. These processes include the creation, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.

It can be applied to industry, healthcare facilities and anywhere medical devices are packaged and sterilized. It does not cover all requirements for packaging of aseptically produced medical devices. Additional requirements may be required for drug/device combinations.

Finally, the packaging of sterilized medical devices should be designed and manufactured in such a way that the medical device can be sterilized and remains sterile under documented storage and transport conditions until the sterile barrier system is damaged or opened.

One of the most critical features of the sterile barrier system and packaging system for sterile medical devices is the assurance of maintaining sterility. Medical devices delivered in sterile condition must be manufactured, packaged and sterilized by appropriate, approved methods. The development and validation of packaging processes is crucial to ensuring sterile barrier system integrity and will remain so until opened by users of sterile medical devices.

There should be a documented process verification program that demonstrates the effectiveness and repeatability of all packaging and sterilization processes. Some of the packaging processes that may affect the integrity of the sterile barrier system together with the sterilization process; sealing, capping or other closure systems, cutting, form/fill/seal, assembly and downstream operations. This document provides a framework of activities and requirements for developing and validating the process used to make and assemble the packaging system.

The term "sterile barrier system" was introduced in 2006 to describe the minimum packaging required to perform the unique functions required by medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system and together form the packaging system. "Preformed sterile barrier systems" shall include partially assembled sterile barrier systems such as bags, headgear bags or hospital packaging reels.

The sterile barrier system is necessary to ensure the safety of the sterilized medical devices. Regulatory authorities recognize their critical nature by considering sterile barrier systems as an accessory or component of a medical device. Preformed sterile barrier systems, which are sold to healthcare institutions for use in internal sterilization, are accepted as medical devices in many parts of the world.

Among the services provided by our organization within the framework of material testing services, there are also ISO 11607-2 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.