Technical Articles

What is ISO 11607-2:2016?

ISO 11607-2:2016 is an international standard that provides guidelines for packaging of medical devices. This standard specifies the requirements and test methods for materials, sterile barrier systems, and packaging systems used in the medical industry. It is crucial to follow these guidelines to ensure the safety and effectiveness of medical devices throughout their lifecycle.

The Importance of ISO 11607-2:2016

In the world of medical devices, packaging plays a critical role in maintaining sterility and providing protection during storage, transportation, and handling. ISO 11607-2:2016 helps manufacturers design packaging systems that meet the necessary criteria for preserving the quality and functionality of medical devices. Compliance with this standard ensures that medical devices are adequately protected against physical damage, microbial contamination, and other potential hazards.

Key Requirements of ISO 11607-2:2016

ISO 11607-2:2016 covers various aspects related to packaging for medical devices. One of the key requirements is the use of validated sterile barrier systems, such as heat-sealed or adhesive-sealed pouches, trays, or wraps. These barriers must be able to maintain sterility until the point of use. The standard also specifies the need for comprehensive documentation, including packaging instructions, labeling, and traceability information.

Furthermore, the standard emphasizes the importance of appropriate package integrity testing. This involves conducting tests to verify the effectiveness of seals, ensuring that they remain intact during various stress conditions. Manufacturers must also consider factors such as compatibility with sterilization methods, environmental conditions, and the expected shelf life of the medical devices.


ISO 11607-2:2016 is a crucial standard in the medical device industry that ensures the integrity and sterility of packaging systems. Compliance with this standard is essential for manufacturers to meet regulatory requirements and provide safe and effective medical devices. By following the guidelines set forth in ISO 11607-2:2016, manufacturers can enhance the quality and reliability of their packaging solutions, thus contributing to the overall safety and success of medical devices.



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