EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 21536 standard. EN ISO 21536 provides specific requirements for knee 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.
There are three levels of International Standards for inactive surgical implants. These regions are as follows, with level 1 being the highest:
This international standard is a level 3 standard and contains requirements that specifically apply to knee joint replacements. The Level 1 standard contains requirements that apply to all inactive surgical implants.
EUROLAB assists manufacturers with EN ISO 21536 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.
