Medical materials contain numerous ingredients such as various additives, antioxidants, plasticizers, degradation compounds, monomers, catalysts, curing agents, accelerators, colorants, processing and washing impurities. Each of these has its own analysis, physicochemical behavior, migration potential and toxicity.
This knowledge allows to design optimized scientific procedures, tailored and customized protocols, and seamless cutting-edge analytical tests.
Recently, updated guidelines, standards and regulations for medical devices are pushing the medical device industry to adopt a more risk-based approach to the safety assessment of products.
For example, the ISO 10993-1 standard developed by the International Standards Organization (ISO) considers the chemical characterization of materials used in manufacture, where possible, as an important first step in the biological evaluation process of a medical device. The extent of chemical characterization depends on different variables such as the nature and duration of body contact, any material safety or toxicological data available, and so forth. However, a characterization study should at least be able to identify chemical compounds potentially released from a device and also quantify potential exposure to the patient.
On the other hand, while the ISO 10993-12 standard explains in detail how test products should be prepared before analytical tests, The ISO 10993-18 standard also provides a more general framework for how a chemical characterization can be performed.
Today he still works on chemical characterization as part of the development and optimization of study protocols. Many chemical characterization projects require optimized or customized designs for the medical device under investigation that take into account a range of parameters such as:
Our organization, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, also provides test services for the determination of the chemical components and structural characterization of medical devices with its trained and expert staff and advanced technological equipment.
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.
EUROLAB reporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK), Enterprise Accreditation Foundation (EAF) based on the accreditation provided by its institution. The Enterprise Accreditation Foundation (EAF) is also a signatory to the United Nations (UN GLOBAL COMPACT).
