EUROLAB laboratory provides testing and compliance service within the scope of ANSI AAMI TIR42 standard. This standard provides information for defining appropriate test methods, determining the source of the particle, assessing the clinical risk of the particle, and determining product particle limits.
The particle can arise from many sources, including materials, environment, and clinical use.
This TIR aims to guide the medical device industry in assessing the particle release propensity of medical devices, identifying sources of particles, applying analytical methods for particle testing, and developing clinical risk-based particle limits.
EUROLAB assists manufacturers with ANSI AAMI TIR42 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.
