DIN 58953-6 Sterilization, Sterile Supply, Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices to be Sterilized

EUROLAB laboratory provides testing and compliance services within the scope of DIN 58953-6 standard. This standard specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain the sterility of ultimately sterilized medical devices up to the point of use.

It does not cover all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. Additional requirements may be required for drug/device combinations.

Finally, the process of designing and developing a packaging system for sterilized medical devices is a complex and critical endeavor. The device components and packaging system must be combined to create a sterile medical device that works efficiently, safely and effectively in the user's hand.

Finally, the purpose of a sterilized medical device packaging system is to allow sterilization, provide physical protection, maintain sterility up to the point of use, and allow aseptic presentation.

The specific nature of the medical device, intended sterilization method(s), intended use, expiration date, transportation and storage all affect packaging system design and material selection.

EUROLAB assists manufacturers with DIN 58953-6 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.