Glossary Term
ISO 11607 (Packaging for Terminally Sterilized Medical Devices)
Definition
ISO 11607 is an international standard that provides guidelines for the design, validation, and testing of packaging systems used for terminally sterilized medical devices. It ensures that packaging maintains sterility, protects the device from damage, and allows for aseptic presentation of the device during use. The standard is divided into two parts: requirements for materials and packaging systems, and validation of packaging processes.
Relevance to the MedTech Industry
ISO 11607 ensures that medical devices remain sterile, protected, and functional throughout their shelf life and transportation, addressing critical safety and regulatory concerns. This standard is essential for maintaining patient safety and enabling compliance with global regulatory requirements.
Additional Information & Related Terms
Key Components of ISO 11607
ISO 11607-1: Materials, Design, and Development
Covers requirements for packaging materials, sterile barrier systems, and protective packaging.
Includes considerations for microbial barriers, sealing, and usability.
ISO 11607-2: Packaging Process Validation
Specifies validation requirements for forming, sealing, and assembly processes.
Ensures packaging systems maintain sterility through transport and handling.
Related Terms
Sterile Barrier System: The part of the packaging that maintains sterility of the medical device.
ISO 11137: A standard for radiation sterilization, ensuring compatibility with packaging materials.
Transportation Simulation Testing: Evaluates the durability of packaging systems during shipping and handling.
Shelf-Life Testing: Validates the ability of the packaging system to maintain sterility over the intended shelf life.