ISO 11607 is a standard designed to ensure that the packaging system provides adequate protection to the device during transportation and storage. Medical devices require protection during transportation and storage to ensure their functionality and safety. The packaging system plays a critical role in providing this protection, especially for terminally sterilized medical devices. ISO 11607 provides guidance for designing, validating, and maintaining packaging systems for these devices to ensure their integrity. MaTestLab is one of the leading testing service providers in the USA and Canada. We have a large network of testing laboratories in the USA.
ISO 11607 Test Method
The following are the steps involved in the packaging system validation process according to ISO 11607:
| Design and Development | The packaging system is designed and developed to ensure the device’s sterility and protection during transportation and storage. It accommodates the device’s dimensions and shape while providing adequate protection. |
| Performance Testing | The packaging system’s performance is tested to ensure it can withstand transportation and storage conditions. The testing includes physical and environmental testing to ensure the packaging system’s integrity. |
| Microbiological Testing | The packaging system’s microbiological integrity is tested to ensure that it can maintain the device’s sterility until the point of use. This testing is performed using a validated method, such as ISO 11737-1:2018. |
| Process Validation | The packaging system’s manufacturing and sterilization processes are validated to ensure that they maintain their integrity and sterility. |
| Labeling and Instructions for Use | The packaging system is labeled with appropriate instructions for use to ensure that the device’s sterility is maintained until the point of use. |
ISO 11607 Specimens
The terminally sterilized medical device is the specimen for packaging system validation according to ISO 11607. The packaging system should be designed and validated to protect the device during transportation and storage and maintain its sterility until the point of use.
