EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and rapid testing services within the scope of ISO 80601-2-58 testing. This standard covers lens removal devices and vitrectomy devices for ophthalmic surgery and this medical electrical equipment, hereinafter referred to as ME equipment. It applies to the basic safety and basic performance of the relevant accessories that can be connected to the equipment.
Hazards inherent in the intended physiological function of ME equipment or ME systems covered by this standard are not covered by the specific requirements in this standard, except in 7.2.13 and 8.4.1 of the general standard.
This second edition includes the comments made during the approval of the first edition as the European Medical Device Directive and amendments made to take into account comments from other National Committees during the finalization of the first edition of this standard.
EUROLAB assists manufacturers with ISO 80601-2-58 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.
