DIN EN ISO 10993-3:2015-02

The basis for biological evaluation of medical devices is often empirical and driven by the relevant concerns for human safety. The risk of serious and irreversible effects, such as cancer or second generation abnormalities, is of particular public concern. It is inherent in the provision of safe medical devices that such risks be minimised to the greatest extent feasible. The assessment of mutagenic, carcinogenic and reproductive hazards is an essential component of the control of these risks. Not all test methods for the assessment of genotoxicity, carcinogenicity or reproductive toxicity are equally well developed, nor is their validity well established for the testing of medical devices. Significant issues with test sample size and preparation, scientific understanding of disease processes and test validation can be cited as limitations of available methods. In the selection of tests needed to evaluate a particular medical device, there is no substitute for a careful assessment of expected human uses and potential interactions of the medical device with various biological systems. These considerations will be particularly important in such areas as reproductive and developmental toxicology. DIN EN ISO 10993-3 presents test methods for the detection of specific biological hazards, and strategies for the selection of tests, where appropriate, that will assist in hazard identification. Testing for the purpose of hazard identification is not always necessary or helpful but, where it is appropriate, it is important that maximum test sensitivity is achieved. The interpretation of test results and their significance for human health is outside the scope of DIN EN ISO 10993-3. In view of the multitude of possible outcomes and the importance of factors such as extent of exposure, species differences and mechanical or physical considerations, risk assessment can only be performed on a case-by-case basis. This standard is directed at manufacturers of medical devices and test laboratories. The committee responsible for this standard is NA 027-02-12 AA "Biologische Beurteilung von Medizinprodukten" ("Biological evaluation of medical devices") at DIN.