EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 556-1 testing. This standard specifies the requirements for a terminally sterilized medical device to be designated 'STERILE'.
Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".
For the purposes of the EU Directives on medical devices, the designation of a medical device as 'STERILE' is only permitted when an approved sterilization process has been performed.
Requirements for the validation and routine control of processes for sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
EUROLAB assists manufacturers with EN 556-1 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.
