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Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application. (Williams, 1999) The critique against this definition usually boils down to the fact that it is not possible to make a single test that determines whether a material is biocompatible or not. Indeed, since the hemostasis of the immune response and repair functions in the body are so complicated it would seem odd that one can make one test to determine the biocompatibility of any given material. Sometimes one hears of biocompatibility testing that is a large battery of in vitro test that is used in accordance with ISO 10993 to determine if a certain material (or rather biomedical product) is biocompatible. These tests do not determine the biocompatibility of a material, but they constitute an important step towards the animal testing and finally clinical trials that will determine the biocompatibility of the material in a given application, and thus medical devices such as implants or drug delivery devices.
In short: there is no such thing as a universally biocompatible material but there are degrees of biocompatibility.
Additional recommended knowledge
Three definitions of biocompatibility
Comments on the above three definitions
All these definitions deal with materials and not with devices. This is a drawback since many medical devices are made of more than one material. Much of the pre-clinical testing of the materials is not conducted on the devices but rather the material itself. But at some stage the testing will have to include the device since the shape, geometry and surface treatment etc of the device will also affect its biocompatibility.
In the literature one quite often stumble upon the adjective form: biocompatible. But according to Williams dictionary this does make any sense because it is biocompatibility is contextual, i.e. much more than just the material itself will determine the clinical outcome of the medical device of which the biomaterial is a part. This also points to one of the weaknesses with the current definition because a medical device usually is comprise of more than one material.
The scope of the first definition is so wide that D Williams tried to find suitable subgroups of applications in order to be able to make more narrow definitions. In the MDT article from 2003 the chosen supgroups and their definitions were:
In these definitions the notion of biocompatibility is related to devices rather than to materials as compared to top three definitions.
There was a consensus conference on biomaterial definitions in Sorrento 2005 September 15-16, http://www.esb2005.it/satellite.html
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Biocompatibility". A list of authors is available in Wikipedia.|