New Accredited Tests for the Biological Evaluation of Medical Devices
Renolab expands its portfolio of accredited services with two new in vitro tests for the biological evaluation of medical devices in accordance with the ISO 10993 series, essential for demonstrating biological safety and supporting the CE marking process.
Consult our ACCREDIA accreditation certificate and the list of accredited tests.
In Vitro Cytotoxicity – XTT Test (ISO 10993-5)
The in vitro cytotoxicity test (XTT assay) enables a rapid and reliable assessment of cell viability following exposure to the sample.
- Recognized method according to ISO 10993-5
- Quantitative evaluation of cytotoxicity
- Support for product development and validation phases
- Reduced testing timelines
The XTT test represents a strategic tool for the early identification of potential biological risks and for supporting the technical documentation required under the MDR framework.
In Vitro Skin Irritation Test (ISO 10993-23)
The in vitro skin irritation test, performed on reconstructed human epidermis models, allows for the scientifically robust determination of a medical device’s irritation potential.
- Compliant with ISO 10993-23
- Validated alternative to animal testing
- Support for regulatory compliance
- Technical data suitable for CE marking purposes
This innovative methodology enables manufacturers to obtain reliable data aligned with the latest European regulatory standards.
Comprehensive Regulatory Compliance Support
Both tests fall within the biological evaluation framework of the ISO 10993 series, providing medical device manufacturers with qualified support throughout the entire regulatory compliance pathway.
Our technical team assists companies in test planning, result interpretation, and integration of data into the technical documentation.