EUROLAB laboratory provides testing and compliance services within the scope of ISO 11979-6 standard. This part of ISO 11979 specifies tests by which the shelf life of sterile intraocular lenses on their final packaging can be determined. These tests include procedures for ensuring the stability of IOLs in distribution and storage.
If, following a risk analysis according to ISO 14971, a product stability study, a package integrity study, or a transport stability study is required, this part of ISO 11979 will apply to the planning and execution of these studies.
Study results should demonstrate that the measured parameters regarding performance, safety and product acceptability are within finished product specifications, when available. In the absence of finished product specifications, the measured parameters should remain within the applicable parts of ISO 11979.
If there are no finished product specifications or applicable limits specified in ISO 11979, comparison with a zero time product should be made.
If the manufacturer wishes to retain the possibility of resterilizing finished lots of intraocular lenses, the finished lot of intraocular lenses used in the stability study must have passed the maximum sterilization cycle allowed under the manufacturer's procedures.
EUROLAB assists manufacturers with ISO 11979-6 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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