EN ISO 11979-8 Ophthalmic Implants, Intraocular Lenses, Part 8: Standard Test for Basic Requirements

Medical Tests

EN ISO 11979-8 Ophthalmic Implants, Intraocular Lenses, Part 8: Standard Test for Basic Requirements

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 11979-8 standard. This standard specifies essential requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

EN ISO 11979-8 Ophthalmic Implants, Intraocular Lenses, Part 8: Standard Test for Basic Requirements

The safety and performance of an intraocular lens should be demonstrated by preclinical and clinical evaluation, including appropriate risk analysis according to ISO 14971.

Where a test method referred to in this standard is not suitable for a particular design or particular application, an alternative test method developed by the manufacturer should be validated, justified and documented.

The manufacturer must have documented evidence that the intraocular lens is biocompatible by evaluation according to ISO 11979-5.

Manufacturers can take into account previous experience and data when determining the scope for further biocompatibility testing.

EUROLAB assists manufacturers with EN ISO 11979-8 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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