ISO 11607 Package Validation Testing for Terminally Sterilized Medical Devices
ISO 11607 outlines the process of validating terminally sterilized medical equipment. This standard ensures that medical device packaging systems maintain sterilization and provide physical protection. The ISO 11607 package testing standard is a requirement for all packages seeking compliance with the European requirements to obtain a CE Mark.
Additionally, the FDA recognizes this package verification standard.
Before reviewing the standard in detail, it is helpful to understand the definitions of the most commonly referenced terms.
ISO 11607 defines a packaging system as a combination of a sterile barrier system and protective packaging.
A sterile barrier system serves as the minimum package that minimizes the risk of microorganism ingress and allows aseptic presentation of sterile contents at the point of use.
Protective packaging consists of materials that prevent damage to the sterile barrier system and its contents from assembly through the point of use.
Manufacturers supply a preformed sterile barrier system partially assembled for filling and final closure or sealing.
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.
What Is the International Organization Behind ISO 11607-1?
ISO 11607-1 is issued by the International Organization for Standardization (ISO) — the international organization that develops and publishes globally recognized standards, including those governing medical device packaging. The standard itself is split into two parts that work together to govern packaging for terminally sterilized medical devices, from material selection through final assembly and shipment.
ISO 11607-1: Requirements for Materials, Sterile Barrier Systems and Packaging
The scope of ISO 11607-1 is best understood through its title: requirements for materials sterile barrier systems and packaging systems. In practice, this means the standard defines which materials qualify for use in a sterile barrier system, how those barrier systems and packaging must perform together to prevent microbial ingress, and what protective packaging must provide to keep a device safe and sterile from manufacture until the moment it’s opened for use.
How ISO 11607-2 Complements Part 1: Forming, Sealing and Assembly
Where ISO 11607-1 focuses on materials and barrier system performance, its companion standard, ISO 11607-2, covers the validation requirements for forming sealing and assembly processes — the manufacturing steps used to actually construct the sterile barrier system. This includes requirements for forming sealing equipment, seal parameter validation, and ongoing verification that sealing and assembly processes stay within validated limits over time. Manufacturers typically validate both parts together: the materials and barrier system requirements in Part 1 only hold up in the field if the forming, sealing and assembly processes used to build the package are equally well validated.
ISO-11607 Shelf Life Stability Testing (Accelerated 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 service life as the number of processing cycles or time period during which a product remains safe and suitable for its intended use when used according to labeling. The standard of reference for this testing is ASTM F1980 the Standard Guide for Accelerated Aging of Sterile Medical Device Packages.
In addition, iso 11607-2 focuses on validating packaging process controls. This ensures consistent sterile barrier system performance across validated packaging processes.
Also, use our Accelerated Aging Calculator for an interactive webpage on aging test duration requirements.
Simulated Distribution and Transit Simulation Testing
Simulated distribution package testing involves exposing the packaging system to the rigors of transit. Testing types can include:
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. Test standards that simulate the transportation cycle include:
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:
- Tensile Testing
- Dye Penetration
- Burst Strength
- Tear Resistance
- Puncture
- Bubble Leak/Emission
Common test standards that evaluate flexible packaging include:
- ASTM F88: Seal Strength Test
- ASTM F1140: Burst and Creep Test
- ASTM F1886: Visual Inspection
- ASTM F1929: Dye Penetration Test
- ASTM F1980: Accelerated Aging
Why is ISO 11607 Medical Device Package Testing Important?
Medical device package testing is crucial because it ensures safety, efficacy, and reliability throughout the device lifecycle. Here are some key reasons why medical device package testing is important:
Product Safety
First, 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
Next, 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
Additionally, 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.
And, as shipment volumes increase, even minor packaging failures can translate into substantial annual losses. Without clear data, it’s difficult to understand the full financial impact. Keystone has created a cost breakdown tool that shows how to quantify what damaged shipments are really costing your business, while providing insights needed to reduce those costs long term.
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
Lastly, 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.
For more ISO testing standards, follow the links below:
- ISO 535: Water Absorptiveness Testing
- ISO 2233: Temperature Conditioning Package Testing
- ISO 2234 Stacking Tests Using a Static Load
- ISO 2247: Packaging for Vibration Tests at Low-Frequency Vibrations
- ISO 8318: Vibration Tests Using Variable Frequencies
- ISO 11607: Package Validation
- ISO 12048: Compression and Stacking Package Testing
- ISO 13355: Vertical Random Vibration Testing
Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or www.keystonecompliance.com for more information.