Biological evaluation of medical devices and biomaterials requires the use of sensitive, precise and reproducible test methods capable of providing accurate and repeatable results. The fulfilment of these requirements is essential for quality assurance and compliance of the testing processes.

The Cell Culture Laboratory (LCC) is RENAR accredited according to SR EN ISO/IEC 17025:2018 for RESEARCH activities, as specified in the Annex of the accreditation certificate no. LI 1304, available electronically on the platform ECO. Accreditation is the guarantee that the activities carried out and the test reports issued fulfil the requirements of the applicable international standards:

• SR EN ISO/IEC 17025:2018 - General requirements for the competence of testing and calibration laboratories;
• SR EN ISO 10993-5:2009 - Biological evaluation of medical devices. Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

The laboratory offers the following services:

• Assessment of cytotoxicity of medical devices by the direct contact test (SR EN ISO10993-5:2009, Chapter 8.3);
• Assessment of cytotoxicity of medical devices by the extract test (SR EN ISO10993-5:2009, chapter 8.2)

The lab is equipped with equipment suitable for the activities carried out, calibrated by the INM and included in a regular programme of metrological checks and calibrations. Pictures

Laboratory team consists of qualified and continuously trained staff in the field of quality assurance, risk management and waste management, working in accordance with the requirements of ISO/IEC 17025 and ISO 9001 standards, as well as safety and environmental regulations.

Contact person: Dr Elena Iulia Oprița - Dr Elena Iulia Oprița - iulia.oprita@incdsb.ro / office@incdsb.ro