The health of patients and users must not be endangered by a medical device. Medical devices that come into contact with the human body must therefore be tested for their biological safety (biocompatibility according to the EN ISO 10993 series of standards "Biological evaluation of medical devices").
Which biological tests must be performed for my medical device (EN ISO 10993-1)?
This question cannot be answered quickly or without additional information. Basically, it depends on the type of body contact and how long this contact lasts.
According to EN ISO 10993-1, the following endpoints must be provided as minimum information for each medical device:
Chemical information / characterization of medical devices (EN ISO 10993-18)
We collaborate with experts to provide you with optimal support in information gathering, chemical analysis, and toxicological evaluation of your product.
Cytotoxicity test (EN ISO 10993-5)
The word "cytotoxicity" describes cell-damaging effects due to toxic substances. To check whether a medical device contains cell-damaging substances, the product, usually in the form of an extract, is incubated with a cultured cell line (in vitro). The cytotoxicity test represents a simple, inexpensive, and rapid assay with good informative value.
Sensitization (EN ISO 10993-10)
After single or repeated contact with the skin surface, sensitizing substances cause an immune reaction and inflammation. Most tests for sensitization are still based on animal experiments. However, due to ethical reasons, validated in vitro tests as part of a testing strategy shall be preferred. We offer the following in vitro sensitization tests: Direct Peptide Reactivity Assay (DPRA, in chemico test, OECD 442C) and ARE-Nrf2 (cell culture based, OECD 442D).
Irritation (EN ISO 10993-23)
Irritating substances cause a local non-specific inflammatory reaction. Reconstructed human epidermis (RhE) is a 3D reconstructed human skin prepared from kerationocytes from healthy donors and grown on cell culture inserts. It is optimally suited for testing medical devices or their extracts for potential skin irritant properties.
We offer alternatives to animal testing
HygCen Austria acts according to the "3R concept”. This is a guideline to replace, reduce and refine animal testing. We contribute our part by offering validated in vitro alternatives for testing medical devices. Aside from overriding animal welfare considerations, these replacement methods are also often much more sensitive, less expensive, and faster to perform than animal testing. We are always informed about innovations and the current state of the art in research and standards.
We are experts and look forward to your request
Professionals with extensive experience in the fields of medical devices, quality management, hygiene, cell biology, molecular biology and toxicology will support you and take care of your individual requirements and wishes.
Contact us.
