EUROLAB, with its state-of-the-art accredited laboratories and expert team, offers precise and rapid testing services within the scope of EN ISO 18113-2 testing. This standard specifies requirements for information provided by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls for professional use. This standard may also apply to accessories. This standard applies to labels and instructions for use of outer and inner containers.
This standard does not apply to:
Manufacturers of in vitro diagnostic (IVD) reagents for professional use provide users with information to ensure the safe use and expected performance of their devices. The type and level of detail varies depending on intended use and country-specific regulations.
The International Medical Device Regulators Forum (IMDRF) promotes the convergence of the development of regulatory systems for medical devices at a global level. Eliminating regulatory differences between jurisdictions could allow patients to access new technologies and treatments sooner. This standard provides a basis for harmonizing labeling requirements for IVD reagents for professional use.
This standard relates to information provided on IVD reagents, calibrators and control materials for professional use only. It is intended for use in conjunction with EN ISO 18113-1, which contains general requirements for information provided by the manufacturer and definitions of general labeling concepts.
EUROLAB assists manufacturers with EN ISO 18113-2 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.
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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.
