EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 16671 standard. EN ISO 16671 defines safety-related requirements for intended performance, design features, pre-clinical and clinical evaluation, sterilization, product packaging, product labeling, and manufacturer-provided information.
EN ISO 16671 applies to ophthalmic irrigation solutions (OISs) used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.
The intended performance of the product should be defined by the manufacturer. Intended performance should include the general requirements for the intended performance of inactive surgical implants outlined in ISO 14630.
The extent to which the intended performance is achieved will be determined by considering published standards, published clinical and scientific literature, validated test results, preclinical evaluation and clinical trials.
The concentration of each ingredient material in the finished product should be determined and documented, and the concentration of each ingredient should be expressed as weight of material per unit volume of solution.
Standard physical or chemical techniques used should be identified and documented, as testing methodology may affect the actual concentration reported. Wherever possible, components shall comply with the mandatory standards specified.
EUROLAB assists manufacturers with EN ISO 16671 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.
