Biocompatibility of dosing pipettes according to ISO 10993

The biocompatibility of medical devices is a crucial factor for patient safety. The ISO 10993 standard defines the requirements for the biological evaluation of materials that come into direct or indirect contact with the human body. Various tests are conducted to ensure that no harmful interactions occur.

According to ISO 10993-1, the biocompatibility assessment begins with a detailed characterization of the materials used. This process identifies potential risks posed by extractable and leachable substances. Based on the duration of exposure and the intended application, the necessary biological tests are determined.

In our case, the biocompatibility of the pipettes we manufacture for oral drug administration requires a cytotoxicity test in accordance with ISO 10993-5, as well as a chemical material characterization according to ISO 10993-18 to detect organic leachable and extractable substances.

The cytotoxicity test is a highly sensitive screening test that can detect both inorganic leachable substances (e.g., critical heavy metals such as Ni, Pb, and Cu) and organic contaminants (e.g., additives, solvents, processing aids, etc.) in the smallest amounts. For this purpose, extractions were performed using our dosing pipette, and the resulting extracts were subsequently incubated with cell cultures. The cell viability was then determined by using biochemical assays. A significant reduction in cell viability would indicate a potential cytotoxic effect. Our dosing pipettes successfully passed this test and exhibit no cytotoxic properties.

Chemical material characterization is typically performed using high-performance liquid chromatography (HPLC) and gas chromatography (GC) combination with a mass spectrometer to identify organic leachable and extractable substances. These analyses enable precise and sensitive screening for solvents, monomers, additives, contaminants, phthalates, and processing aids. Particular attention was given to the selection of extraction media and elevated extraction conditions to ensure maximum biological safety. The extraction of potentially present substances was carried out using media of varying polarity. The extracted substances were then analyzed using HPLC- and/or GC-MS, characterized, and toxicologically evaluated.

These investigations are essential to ensure that our pipettes do not cause toxic, allergenic, or irritating effects. Especially for dosing pipettes used for oral drug administration, a comprehensive biological safety assessment is indispensable. The dosing pipettes from elmplastic have been tested in accordance with the requirements of ISO 10993 and meet all necessary biocompatibility criteria. Our products are safe to use and ensure the high quality required in the medical and pharmaceutical industries. This provides our customers with the assurance that our pipettes comply with the highest safety standards.