Abstract
Electronic devices or final products that are used in human medicine as extracorporeal or even electrically powered implantable medical devices are subject of a number of legal and uniform regulations. Such regulations are for example the classification of devices into one of the hazard classes I to III according to Annex IX of the Medical Device Directive (MDD) or to FDA regulations and the classification of the energy supply into the electrical protection classes I or II according to IEC 60601-1:2005 part 1. The connection between patient and medical device can be application type body (B), body floating (BF) or cardiac floating (CF) according to IEC 60601-1. To obey the regulations, an accurate selection of materials for the medical device is required. Guidelines for the assessment of applicability or inapplicability of functional materials for such systems are given by standard ISO 10993 (parts 1 to 18) that describes the nature of body contact and the contact duration of products with patients. On that score the manufacturer commits himself to proof the fulfillment of all requirements regarding all applying European and American conformity assessment procedures for medical devices.
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Notes
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Ames test was developed in the late ’60s by Bruce Ames as a simple test method for rapid detection of carcinogenic substances [2].
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Uhlemann, J., Kirchner, R., Wolter, KJ. (2012). Biocompatibility of Packaging Materials. In: Gerlach, G., Wolter, KJ. (eds) Bio and Nano Packaging Techniques for Electron Devices. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-28522-6_24
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