ISO 16672 Standard Test for Ophthalmic Implants, Ocular Endotamponades

Medical Tests

ISO 16672 Standard Test for Ophthalmic Implants, Ocular Endotamponades

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 16672 testing. This standard applies to ocular endotamponades (OE), a group of non-rigid surgically invasive medical devices that are inserted into the vitreous cavity of the eye to flatten a detached retina and place it on the retinal pigment epithelium (RPE) or buffer the retina.

ISO 16672 Standard Test for Ophthalmic Implants, Ocular Endotamponades

Provides indication of requirements for intended performance, design features, preclinical and clinical evaluation, sterilization, product packaging, product labeling, and manufacturer-supplied information for endotamponades used in ocular surgery.

This International standard defines non-rigid medical devices that function primarily mechanically and are used to reposition or buffer a detached retina compatible with the ocular environment.

As with heavy fluids such as perfluorocarbons, they are used during surgery and are either removed at the end of surgery or designed to remain in the vitreous cavity until the retina is reattached.

The manufacturer should describe and document the functional properties of the OE in terms of its chemical composition and physical properties, intended surgical applications, conditions of use, and effects on and maximum contact time with ocular tissues.

EUROLAB assists manufacturers with ISO 16672 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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