EUROLAB laboratory provides testing and compliance services within the scope of EN 45502-1 standard. This part 45502 of EN 1 specifies the generally applicable requirements for active implantation medical devices.
For certain types of active implantation medical devices, these general requirements are supplemented or replaced by the requirements of the specific standards that form appendices to this European standard. The tests specified in EN 45502 are type tests and must be performed on specimens of active implantable medical devices to demonstrate conformity.
This part 45502 of EN 1 applies not only to electrically powered active implantable medical devices, but also to devices powered by other energy sources (eg gas pressure or springs).
This part 45502 of EN 1 also applies to certain non-implantable parts and accessories of active implantable medical devices. The terminology used in this European standard is intended to be compatible with the terminology of Directive 90/385/EEC.
EUROLAB assists manufacturers with EN 45502-1 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.
