ISO 15798 Standard Test for Ophthalmic Implants, Ophthalmic Viscous Surgical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 15798 testing. This standard applies to ophthalmic viscous surgical devices (OVDs), a class of surgically invasive medical devices with viscous or viscoelastic properties intended for use during surgery on the anterior segment of the human eye.

OVDs are designed to create and maintain space, protect intraocular tissues, and manipulate tissues during surgery.

This standard specifies safety-related requirements for intended performance, design features, preclinical and clinical evaluation, sterilization, product packaging, product labeling, and information provided by the manufacturer of these devices.

The flexibility of the OVD should be demonstrated at the same frequencies used to determine complex viscosity. It will be displayed up to at least 100 Hz. Measurements will be made at 25°C ± 2°C.

Test equipment and other measurement conditions should be documented. Both log viscous G' and log elastic G' modules will be plotted against log frequency. Data can also be presented as a graph of percent elasticity versus log frequency.

EUROLAB assists manufacturers with ISO 15798 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.