Medical Device Shelf-Life and Package Testing to ISO 11607
ANSWERED ON THIS PAGE:
- What is the ISO 11607 series of standards for medical devices?
- Which device type requires testing to ISO 11607?
- How do we determine the shelf-life and package testing requirements for our device?
Effective packaging and packaging materials are essential to preserving the sterility of medical devices. However, the integrity of packaging material can degrade over time due to environmental exposure, or be compromised between the time it leaves the production line and the day it gets used. Packaging can be damaged during packing, transportation, distribution, storage, or end user handling. As a result, rigorous testing of medical device shelf-life and packaging systems is mandatory in most major jurisdictions around the world.
In collaboration with our colleagues at UL, Emergo can help you determine the testing requirements for your device as well as perform shelf-life and package testing to ISO 11607.
Types of tests to verify medical device packaging compliance and sterility
The ISO 11607 standard requires that specific properties of medical devices as well as their packaging remain stable for the duration of their shelf life. To back up claims of compliance to ISO 11607, manufactures should conduct appropriate validation studies on their devices’ shelf life and transport stability.
The ISO 11607 series includes two testing standards for medical devices:
- ISO 11607-1 covers requirements for materials, sterile barriers, and packaging of sterilized medical devices.
- ISO 11607-2 covers requirements for validation of sterile medical device packaging processes.
Validation studies for ISO 11607 compliance should also cover packaging processes including sterile barrier system forming and sealing. Additional standards from the International Safe Transport Association (ISTA) and ASTM International may also be applicable for some combined stability and packaging validation studies.
We can provide shelf-life and package testing to ISO 11607 requirements
Validating packaging for sterilized medical devices is a complex process. However, we can help you increase the likelihood of packaging system acceptance and reduce delays in bringing new medical devices to market. Here’s how we can help:
- Evaluate your device to determine applicable standards and testing requirements.
- Perform testing that meets ISO 11607-1 and 11607-2 requirements.
- Dye tests for seal integrity, peel and burst tests, air permeability tests, and tests for microbiological tightness.
- Additional performance and biological evaluation testing is available for stressed devices.
Emergo and UL are experts in this type of testing and can help you determine the exact regulatory requirements for your devices. Our regulatory consultants can prepare shelf-life and package testing documentation for regulatory submissions in the US, Europe, and markets worldwide.
Common shelf-life and package testing questions
How does ISO 11607-1 address shelf-life testing for device packaging?
ISO 11607-1 describes how to validate the integrity of the sterile barrier system (SBS) over the course of the device sterilization process and during subsequent handling, distribution and storage. Validation is typically achieved by demonstrating the integrity of the SBS over the intended shelf-life of the device. Real-time aging is required to fully demonstrate compliance with the standard’s requirements and can take as long as five years to complete. However, regulatory authorities typically accept test reports that validate packaging stability using accelerated aging studies, pending receipt of data from real-time aging assessments.