EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 14602 standard. EN ISO 14602 specifies special requirements for inactive surgical Implants for osteosynthesis, referred to as implants.
EN ISO 14630, in addition to EN ISO 14602, gives specific requirements for intended performance, design features, materials, design evaluation, production, sterilization, packaging and information provided by the manufacturer.
Generally, inactive surgical implants for osteosynthesis are used in trauma treatment or corrective surgery. They maintain the reduction of broken bones and stabilize bony (or adjacent) structures to allow bone healing or fusion or to provide support or correction. When they reach their purpose, the implants are either removed or left in place.
Alternative methods demonstrating compliance are acceptable, especially with regard to implants with satisfactory long-term clinical performance.
EUROLAB assists manufacturers with EN ISO 14602 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.
