We can offer a range of biocompatibility testing services including:

+ ISO 10993-5

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR IN VITRO CYTOTOXICITY

ISO 10993-5 provides the general requirements for evaluating the cytotoxic potential of a medical device. The in vitro tests described assess the cytotoxic potential of a device or material to inhibit cell growth or cause cell death and can be performed qualitatively and/or quantitatively. There are three categories of test – extract test, direct contact test and indirect contact test. The appropriate test method is selected based on the nature of the sample, the potential site of use and the nature of use.

+ OECD 439

IN VITRO SKIN IRRITATION – RECONSTRUCTED HUMAN EPIDERMIS TEST METHOD

OECD 439 described an in vitro procedure that may be used for the hazard group identification of irritant chemicals in accordance with the UN Globally Harmonized System of Classification and Labelling (GHS) in Category 2. Reconstructed human epidermis is exposed to the test substance, following exposure cell viability is measured quantitatively. Irritant test substances are identified by their ability to decrease cell viability below defined threshold levels.

+ USP 87

BIOLOGICAL REACTIVITY TESTS – IN VITRO

USP 87 details test methods designed to determine the biological reactivity of mammalian cell cultures following contact with elastomeric plastics and other polymeric materials with direct or indirect patient contact or of specific extracts prepared from the materials under test. Three tests are described – agar diffusion test, direct contact test and elution test. The appropriate test method is selected based on the nature of the sample, the potential site of use and the nature of use. The biological reactivity is rated on a scale of 0 to 4 qualitatively.