EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 21535 standard. EN ISO 21535 provides specific requirements for hip joint replacement implants.
Regarding safety, this international standard specifies requirements for intended performance, design features, materials, design evaluation, manufacturing, sterilization, packaging, manufacturer-provided information, and test methods.
Regarding the requirements for metal-on-metal and ceramic-on-ceramic joint surfaces, there is not yet sufficient information on surface roughness, diameter tolerance and clearances to provide specification of these parameters in this edition of this international standard.
For a femoral component or a modular femoral head that is intended to be structurally and functionally compatible only with certain acetabular cups, the label, instruction leaflet, or manual should specify which acetabular cups it is compatible with.
EUROLAB assists manufacturers with EN ISO 21535 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.
