CHEMTOX biolab
Chemtoxbiolab was established by academicians from Yıldız Technical University and an experienced team that has been operating in the private sector for many years. As a result of the team spirit and synergy created by this team, it has become the first accredited laboratory in Turkey for ISO 10993-18 Chemical Characterisation and one of the few accredited laboratories in Europe. Chemtoxbiolab has started to work for Good Laboratory Practices (GLP) in the field of both chemical and physical characterisation tests of medical devices and has set the target of completing the process in 2024.
"Precision
is the key"
CHEMTOXbıolab
WHO WE ARE
Chemtoxbiolab laboratory, which determines it’s main purpose as carrying out tests on product performance and safety of medical device manufacturers in accordance with the relevant standard requirements, started its activities within Yıldız Technical University – Technology Transfer Office in 2019.
The main target of the laboratory was determined as chemical characterisation according to EN ISO 10993-18 and toxicological risk assessment studies within the scope of ISO 10993-17 before biocompatibility tests, which are lacking in both local and the global market.
In addition, within the scope of our laboratory’s field of activity, EN ISO 8836-2020, EN ISO 10555-1-2013, EN ISO 10555-2:2013, EN ISO 20696-2018, EN ISO 20697-2018, EN ISO 7886-2:2020, EN ISO 80369-20:201 EN ISO 7864:2016, EN ISO 8536-4:2020 and EN ISO 8536-9: 2015 standards, it provides chemical and physical performance testing of catheters (chest catheter, rectal catheter, IV cannula, urethral catheter), syringes and infusion sets.
Our laboratory has renewed its device park especially in physical tests and started to provide services for the pre-clinical testing of implants. These tests aim to ensure that the performance test requirements of the implants, the adequacy of the biomechanical (static and dynamic) data of the implants comply with national and international test standards.
In this context, our laboratory serves according to ASTM F 2267, ASTM F 2077, ASTM F 382, ASTM F 384, ASTM F 1717, ASTM F 1798, ASTM F 1541, ASTM F 1264, ASTM F 543 standards.,
MISSION
Chemtoxbiolab’s main field of activity is to provide chemical and physical tests of medical devices in accordance with national and international standards.
VISION
Chemtoxbiolab; In order to be a reliable and competent laboratory at national and international level in the field of physical and chemical testing activities of medical devices, set it’s main vision as actively participating in the development of standards applied in this field and in academic scientific studies.
