Biocompatibility testing and evaluation of medical devices is performed to determine the potential toxicity resulting from contact of the device with the body. The device materials should not-either directly or through the release of their material constituents-produce adverse local or systemic effects, be carcinogenic, or produce adverse reproductive and developmental effects. The biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation programme within a risk management process in accordance with ISO 14971 as set out in the figur
As per ISO 10993 the choice of tests and the data required in a biological evaluation and their interpretation shall take into account the chemical composition of the materials, including the conditions of exposure as well as the nature, degree, frequency and duration of exposure of the medical device or its constituents to the body, enabling the categorization of devices to facilitate the selection of appropriate tests.
The biological evaluation performed based on ISO 10993 categorizes medical devices according to: