EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 10993-8 testing. This part of EN ISO 10993 specifies requirements for the use of reference materials or certified reference materials used to determine the biological response of a material. Specifies the selection and qualifications of reference materials for biological testing and the properties of reference materials for use as experimental controls.
The information given in this part of EN ISO 10993 should be considered in addition to EN ISO 10993-12, which specifies and guides the requirements for the procedures to be followed in the preparation of medical device samples for testing in biological systems according to one or more standards.
The use of reference materials described in EN ISO 10993-12 and elsewhere in this part of EN ISO 10993 is limited to biological screening of materials intended for use in the manufacture of medical devices. However, although not intended, they are often used in the performance evaluation of the finished medical device.
When available, the vertical standard for the device should address biological testing of the product in the device's performance environment. Biological tests described in the vertical product standard take precedence over tests for screening materials for compatibility.
RMs or CRMs used to determine the biological response of a material should be evaluated with each biological test procedure in which use of the material is desired.
EUROLAB assists manufacturers with EN ISO 10993-8 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.
