EVS-EN ISO 7405:2025

ISO 7405 specifies test methods for evaluating the biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

Only the test methods for which the members of the committee considered there was sufficient published data have been included. In recommending test methods, the need to minimise the number and exposure of test animals was given a high priority. The decision to undertake tests involving animals must be reached only after a full and careful review of the evidence indicating that a similar outcome cannot be achieved by other types of tests.

To keep the number of animals required for tests to an absolute minimum, consistent with achieving the objective indicated, it can be appropriate to conduct more than one type of test on the same animal at the same time, e.g. pulp and dentine usage test and pulp capping test. However, by ISO 10993-2, these tests are performed both in an efficient and humane way. On all occasions when animal testing is undertaken, such tests are conducted empathetically and by standardised procedures.

ISO 7405 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

ISO 7405:2025 text has been approved in Europe as EN ISO 7405:2025 without any changes.