ISO 18369-2 Ophthalmic Optics - Contact Lenses - Standard Test for Tolerances

ISO 18369-2 specifies the tolerance limits for the major optical and physical parameters of hard cornea, hard scleral and soft contact lenses at the time of manufacture. These tolerances may not apply for other purposes such as shelf life studies.

There are three meaningful methods for determining the conformity of contact lens parameters to specified tolerances:

• 100% inspection - a method of determining conformity to a given value, including tolerances based on the evaluation of each item in the population to be evaluated;
• Acceptance sampling - a method for assigning a product to a certain compliance level;
• Statistical estimation of performance-process evaluation in which a representative sample is identified and used to estimate performance.

Eligibility may be based on supplied lens lots or supplier data for third party audits.

When examined as specified in ISO 18369-3, the contact lens must not show any inclusions or surface defects that could interfere with its intended functional use.

EUROLAB assists manufacturers with ISO 18369-2 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.