Materials with skin contact

The EN ISO 10993 standard applies to the assessment of the biological compatibility of medical devices. The standard classifies medical devices according to the type and duration of intended body contact and identifies biological risks which must be evaluated according to the respective category of the product in question. The purpose of the biological assessment is to determine whether the medical device or its materials are expected to pose physiological hazards as a result of contact with the patient. Accordingly, the tests pursuant to EN ISO 10993 Part 5 (cytotoxicity) and EN ISO 10993 Part 10 (irritation and sensitisation) are relevant for Ottobock materials with skin contact.

Cytotoxicity test (EN ISO 10993 Part 5)

The cytotoxicity test is recognised as the basic biological test for all medical devices and their materials. Through the use of cell cultures, it is possible to establish that no cytotoxic substances are released from the material when used properly. Solids are extracted using a culture medium or other suitable solvents and then used in the investigation. The cytotoxicity test provides evidence of the biological compatibility of materials used to manufacture medical devices. Relevant Ottobock materials have successfully passed this test; therefore, no cytotoxicity effect is expected. The biological compatibility of the relevant Ottobock materials is confirmed in accordance with the EN ISO 10993-5 standard or by equivalent data.

Testing for irritation and sensitisation (EN ISO 10993 Part 10)

The most common test method is the patch test. This is a provocation test used to determine if there is a contact allergy. In this test, the test specimens or extracts are applied exclusively to the skin. As a rule, the test substances are applied to a test patch that has been especially prepared and is applied “on the skin” (=epicutaneous) of the patient. The patch is left in place for 48 hours before being removed. The physician examines the area of skin for possible changes (reddening, swelling) 15 to 30 minutes after it is removed; this examination is repeated after two and three days as well as possibly again later. The patch test is indicative of the biological compatibility of materials for the production of medical devices. Relevant Ottobock materials have successfully passed this test, so skin irritation or allergic sensitisation are not expected. The biological compatibility of the relevant Ottobock materials is confirmed in accordance with the EN ISO 10993-10 standard or by equivalent data.

A statement regarding materials and semi-finished products produced by Ottobock SE & Co. KGaA for use in medical devices can be found under the following link.