ISO 11607 Medical Device Package Testing

ISO 11607 Package Validation Testing for Terminally Sterilized Medical Devices

The process of validating terminally sterilized medical equipment is outlined in ISO 11607. This standard ensures that medical device packaging systems maintain sterilization and provide physical protection. Additionally, the ISO 11607 package testing standard is a requirement for all packages seeking compliance with the European requirements to obtain a CE Mark.

The FDA also recognizes this package verification standard as well.

Before digging into the standard, it is important to understand the definitions of some of the most common and important terms referenced in the standard.

A packaging system is defined as a combination of a sterile barrier system and protective packaging.

A sterile barrier system is a minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use.

Protective packaging is the configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use.

A preformed sterile barrier system is a sterile barrier system that is supplied partially assembled for filling and final closure or sealing. Examples include pouches, bags, and open reusable containers.

Sterile fluid-path packaging is a system of protective port covers and/or packaging designed to ensure sterility of the portion of the medical device intended for contact with fluids. An example is the interior of the tubing for the administration of intravenous fluid.

Summary of ISO-11607 Medical Device Packaging Validation

Shelf Life Stability Testing (accelerated aging and real-time aging)

Accelerated aging testing provides insight into a packaging system’s performance while undergoing extreme conditions. These conditions can include extreme temperatures, humidity conditions, thermal shock, and other environmental conditions.

The objective of this testing is to validate shelf-life claims. ISO 11607 defines the service life as the number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and safe for its intended use when used according to the labeling. The standard of reference for this testing is ASTM F1980 the Standard Guide for Accelerated Aging of Sterile Medical Device Packages.

Check out our Accelerated Aging Calculator for an interactive webpage on aging test durations.

Simulated Distribution and Transit Simulation Testing

Simulated distribution package testing involves exposing the packaging system to the rigors of transit. Testing types can include:

By going through this process, manufacturers can identify potential issues with the packaging system. Knowing the weaknesses in a system and addressing them in the lab as opposed to in the field has many benefits. These include reduced damage, lower returns, and improved customer satisfaction and reputation. Test standards that simulates the transportation cycle includes:

Seal Strength and Flexible Package Integrity Testing

ISO 11607 defines a seal as a result of joining surfaces together by fusion to form a microbial barrier. Seal strength is the mechanical capacity of the seal to withstand force. Lastly, seal integrity is the characteristic of a seal to minimize the ingress of microorganisms.

Several tests can be used to evaluate the package integrity and seal strength. These tests include:

Common test standards that evaluate flexible packaging include:

Why is Medical Device Package Testing Important?

Medical device package testing is crucial for several reasons, as it ensures the safety, efficacy, and reliability of medical devices throughout their lifecycle. Here are some key reasons why medical device package testing is important:

Product Safety

Medical devices are used to diagnose, treat, and monitor patients, so their safety is of paramount importance. Package testing helps ensure that the packaging adequately protects the device from physical damage, contamination, and other environmental factors, reducing the risk of harm to patients or healthcare professionals.

Sterility Assurance

Many medical devices, especially those used in surgical procedures or for direct patient contact, need to be sterile to prevent infections. Package testing validates the integrity of the packaging to maintain sterility, preventing the introduction of microorganisms that could lead to post-surgical infections or other complications.

Product Integrity During Transit and Storage

Medical devices are often shipped and stored under various conditions. Package testing simulates real-world scenarios to assess the ability of the packaging to withstand vibrations, temperature fluctuations, and other stresses during transportation and storage. This helps ensure that the device arrives at its destination in proper working condition.

Compliance with Regulatory Requirements

Medical device packaging must meet stringent regulatory standards set by organizations like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other health authorities worldwide. Package testing is a necessary step in obtaining regulatory approvals or certifications, and non-compliance could result in delays or even the denial of market access.

Shelf-life Determination

Medical devices often have a defined shelf life during which they must remain effective and safe. Package testing helps evaluate the packaging’s ability to maintain the device’s properties over time, allowing manufacturers to determine appropriate expiration dates.

Expert ISO 11607 Packaging Validation Testing of Medical Devices

Keystone Package Testing provides expert medical device package testing. Our large ISO-17025 accredited test lab is full of test equipment including dozens of temperature and humidity chambers, shakers, compression machines, and other test apparatus.

In addition to the ISO 17025 accreditation, the lab is also accredited to ISTA, Amazon, ASTM, Sam’s Club, General Motors, QVC, and many other package testing standards. Our certified engineers and technicians have a thorough knowledge of the packaging validation requirements.

Our proven process has allowed us to be recognized as one of the fastest-growing test labs in the industry. We provide constant communication and guidance throughout the entire process. From the creation of a test plan to the issuance of a thorough test report, our experts provide the guidance and feedback manufacturers want.

If you require medical package testing and the need to validate healthcare packaging, you came to the right place. Please request a quote to get started. If you are not sure of what you need, contact us and we can answer any package testing questions that you might have.


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