EUROLAB laboratory provides testing and compliance services within the scope of ISO 11979-5 standard. This part of ISO 11979 specifies specific requirements for the assessment of biocompatibility of materials for intraocular lenses, including the processing conditions to manufacture them.
These requirements include evaluation of physicochemical properties related to biocompatibility. It also provides guidance on performing ocular implantation testing.
The following physicochemical tests will be considered:
In addition, the risk assessment will include an assessment of possible significant changes, such as calcification. This risk assessment should consider the material's clinical use history and animal models to test the material's long-term stability.
EUROLAB assists manufacturers with ISO 11979-5 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.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
