ISO 15004-1 Ophthalmic Instruments - Test for All Ophthalmic Instruments

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 15004-1 testing. This standard specifies the basic requirements for non-invasive, active and inactive ophthalmic instruments and devices to improve low vision.

This document also applies to tonometers, but not to other ophthalmic instruments used in contact with the eyeball.

This document does not apply to operating microscopes, endoscopes and devices designed for laser examination or laser treatment of the eye.

Ophthalmic devices that are intended to transmit energy, substance, or other elements without significant change between an active ophthalmic device and the patient are not considered an active ophthalmic device.

It is an ophthalmic instrument that is connected to an electrical energy source or any power source other than those produced directly by the human body or gravity and acts by converting this energy.

If another device is used in conjunction with an ophthalmic device, the coupling system must not reduce the optical radiation safety of both devices and the optical radiation hazards of the combined system must not exceed the levels given in this part of ISO 15004.

Scanners will be evaluated using pulsed device criteria when their scan length is greater than the diameter of the measuring aperture. Where the scan length is less than or equal to the measurement aperture, it will be evaluated using continuous wave criteria.

EUROLAB assists manufacturers with ISO 15004-1 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.