EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 556-2 testing. This standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
For the purposes of EU Directives on medical devices, it is permissible to designate a medical device as 'STERILE' when an approved manufacturing and sterilization process has been followed.
The requirements for the validation and routine control of aseptic processes are specified in EN ISO 13408 1. Special requirements for aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.
EUROLAB assists manufacturers with EN 556-2 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.
